Medicines
The Human Medicines Regulations 2012
Made19th July 2012
Laid before Parliament24th July 2012
Coming into force14th August 2012
The Secretary of State and the Minister for Health, Social Services and Public Safety make the following Regulations. They do so in exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 1972M1, having been designated for the purposes of section 2(2) of that Act in relation to medicinal productsM2 and to measures in the veterinary and phytosanitary fields for the protection of public healthM3. They do so in exercise also of the powers conferred by sections 87(1), 88(1) and (2), 91(2), and 129(1), (2) and (5) of the Medicines Act 1968M4, having consulted such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations in accordance with section 129(6) of that Act.C10
PART 1 General¶
1 Citation and commencement¶
C12 Medicinal products¶
2A Definition of advanced therapy medicinal product etc.¶
3 Scope of these Regulations: special provisions¶
3A Preparation and assembly of medicinal products used for vaccination against an infectious disease or in the reformulation of such products¶
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- “relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence).
4 Special provisions for pharmacies etc¶
5 Classification of medicinal products¶
6 The licensing authority and the Ministers¶
7 Advertisements relating to medicinal products¶
8 General interpretation¶
- “the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use;
- “the 2018 Regulations” means the Health Service Products (Provision and Disclosure of Information) Regulations 2018;
- “active implantable medical device”—
- has the meaning given in regulation 2 of the Medical Devices Regulations 2002; or
- to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 137 of those Regulations;
- “active substance” means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;
- “administer” means administer to a human being—
- orally, by injection, or by introduction into the body in any other way; or
- by external application (whether or not by direct application to the body),
and any reference in these Regulations to administering anything is to administering it in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, a substance used as a vehicle; - F1153...
- “adverse reaction” means a response to a medicinal product that is noxious and unintended;
- “advisory body” has the meaning given by regulation 12(1);
- “agreed paediatric investigation plan” means a paediatric investigation plan which the licensing authority has agreed in accordance with regulation 50B;
- “Annex I to the 2001 Directive” means, in relation to UKMA(GB) or UKMA(UK)(Category 1), Annex I to the 2001 Directive, as modified in accordance with Schedule 8B;
- “approved country for batch testing list” means the list published by the licensing authority under paragraph 14(3) of Schedule 7 (obligations of qualified persons) and “approved country for batch testing” means a country included in that list;
- “approved country for import list” means the list published by the licensing authority under regulation 18A (approved country for import) and “approved country for import” means a country included in that list;
- “appropriate practitioner” means an appropriate practitioner within the meaning of regulation 214;
- “Article 126a authorisation” means an authorisation granted by the licensing authority under Part 8 of these Regulations;
- “assemble”, in relation to a medicinal product or an active substance, includes the various processes of dividing up, packaging and presentation of the product or substance, and “assembly” has a corresponding meaning;
- “biological medicinal product” and “biological substance” have the meaning given in the third indent of paragraph 3.2.1.1.(b) of Annex I to the 2001 Directive;
- “blood component” means any of the following—
- red cells;
- white cells;
- platelets; and
- plasma;
- “the British Pharmacopoeia” means the British Pharmacopoeia referred to in regulation 317;
- “brokering” means all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person;
- “business” includes—
- a professional practice;
- any activity carried on by a body of persons whether corporate or unincorporated; and
- the provision of services by or on behalf of the Secretary of State, the Minister for Health, Social Services and Public Safety, the Welsh Ministers or the Scottish Ministers as the case may be under the following enactments—
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- “certificate of registration” means a certificate of registration granted by the licensing authority under Part 6 of these Regulations and—
- “COR(UK)” means such a certificate in force in the whole United Kingdom;
- “COR(GB)” means such a certificate in force in Great Britain only;
- “COR(NI)” means such a certificate in force in Northern Ireland only;
- “clinical management plan” means a written plan relating to the treatment of an individual patient and agreed by—
- the patient;
- the doctor or dentist who is a party to the plan; and
- any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;
- “clinical trial” has the meaning given by regulation 2 of the Clinical Trials Regulations;
- “the Clinical Trials Directive” means Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use M11;
- “the Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004 M12;
- “the Commission” has the meaning given by regulation 9(1);
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- “common name” in relation to a medicinal product, active substance or excipient means—
- its international non-proprietary name recommended by the World Health Organisation; or
- if such a name does not exist, its usual common name;
- “the Committee for Medicinal Products for Human Use” means the committee established under Article 5(1) of Regulation (EC) No 726/2004;
- “conditional marketing authorisation” means a UKMA(UK)(Category 1) granted under regulation 49(1)(a) in accordance with regulation 58F;
- “community practitioner nurse prescriber” means a person—
- who is a registered nurse or a registered midwife; and
- against whose name is recorded in the professional register an annotation signifying that the person is qualified to order drugs, medicines and appliances from the Nurse Prescribers' Formulary for Community Practitioners in the current edition of the British National Formulary;
- “contravention” includes failure to comply (and “contravene” has a corresponding meaning);
- “coronavirus” and “coronavirus disease” have the meanings given in section 1(1) of the Coronavirus Act 2020;
- “cosmetic” means any substance or preparation intended to be applied to the surfaces of the human body (including the epidermis, pilary system and hair, nails, lips and external genital organs), or the teeth or buccal mucosa, wholly or mainly for the purpose of—
- perfuming them;
- cleansing them;
- protecting them;
- caring for them or keeping them in condition;
- modifying their appearance (for aesthetic purposes or otherwise); or
- combating body odours or normal body perspiration;
- “country” means a country or territory;
- “dentist” means a person registered in the dentists register under section 14 of the Dentists Act 1984 M13;
- “Directive 2001/18/EC” means Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration;
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- “disease” includes any injury, ailment or adverse condition, whether of body or mind;
- “dispensing content for patients”, in relation to an internet service, means content communicated publicly by an internet service provider as part of an internet service (for example, on a website) which is relevant to the dispensing of orders for the supply of medicinal products;
- “doctor” means a registered medical practitioner;
- “EAMS medicinal product” means a medicinal product that—
- has been included in the Early Access to Medicines Scheme by means of the licensing authority issuing an EAMS scientific opinion in respect of it; and
- remains in the scheme by virtue of the EAMS scientific opinion not ceasing to have effect in respect of it by virtue of regulation 167D;
- “EAMS scientific opinion” is to be construed in accordance with regulation 167C(2)(b);
- “EAMS scientific opinion holder” means the holder of a EAMS scientific opinion, and accordingly, is the person who places on the market the product to which the opinion relates;
- “Early Access to Medicines Scheme” means the scheme of that name established and operated under regulation 167C(1);
- “effervescent”, in relation to a tablet or capsule, means containing not less than 75 per cent, by weight of the tablet or capsule, of ingredients included wholly or mainly for the purpose of releasing carbon dioxide when the tablet or capsule is dissolved or dispersed in water;
- “electronic communication” means a communication transmitted (whether from one person to another, from one device to another or from a person to a device or vice versa)—
- by means of an electronic communications network within the meaning of section 32(1) of the Communications Act 2003 M14; or
- by other means but while in an electronic form;
- “electronic signature” has the meaning given within Article 3(10) of Regulation (EU) 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market;
- “the EMA” means the European Medicines Agency established by Regulation (EC) No 726/2004;
- “enactment” includes primary and secondary legislation of the devolved administrations in Wales, Scotland and Northern Ireland;
- “enforcement authority” means the Secretary of State, the Minister for Health, Social Services and Public Safety or a person on whom a function of enforcing a provision of these Regulations has been conferred by virtue of regulations 323 or 324;
- “EU agreed paediatric investigation plan” means a paediatric investigation plan agreed in accordance with the Paediatric Regulation;
- “EU Clinical Trials Regulation” means Regulation EU No. 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products, and repealing Directive 2001/20/EC;
- “EU Exit Regulations” means the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019;
- “EU marketing authorisation” means a marketing authorisation granted or renewed by the European Commission under Regulation (EC) No 726/2004;
- “European Economic Area” or “EEA” means the European Economic Area created by the EEA agreement;
- “the European Pharmacopoeia” means the European Pharmacopoeia published by the European Directorate for the Quality of Medicines;
- “excipient” means any constituent of a medicinal product other than the active substance and the packaging material;
- “exempt advanced therapy medicinal product” has the meaning given in regulation 171;
- “expert advisory group” has the meaning given by regulation 14(1);
- “export” means export, or attempt to export, from the United Kingdom, whether by land, sea or air;
- “external use” in relation to a medicinal product—
- means its use by application to the skin, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal in circumstances where local action only is necessary and systemic absorption is unlikely to occur; but
- does not include its use by means of a throat spray, nasal spray, nasal inhalation or teething preparation or by means of throat pastilles, throat lozenges, throat tablets or nasal drops;
- “falsified medicinal product” means any medicinal product with a false representation of—
- its identity, including its packaging and labelling, its name or its composition (other than any unintentional quality defect) as regards any of its ingredients including excipients and the strength of those ingredients;
- its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
- its history, including the records and documents relating to the distribution channels used;
- “Fees Regulations” means the Medicines (Products for Human Use) (Fees) Regulations 2016;
- “general practitioner” means a medical practitioner who is included in the General Practitioner Register kept under section 34C of the Medical Act 1983;
- “the Good Manufacturing Practice Directive” means —
- in the case of a medicinal product manufactured or assembled in, or imported into, Great Britain—
- Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A, or
- if Regulations have been made under the powers in regulation B17(1), and have come into force, those Regulations;
- in the case of a medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use;
- “the Health and Care Professions Council register” means the register established and maintained by the Health and Care Professions Council under article 5 of the Health Professions Order 2001 M15;
- “health care professional” means—
- a doctor;
- a dentist;
- a pharmacist;
- a registered nurse;
- a registered midwife;
- a registered optometrist;
- a registered osteopath as defined in section 41 of the Osteopaths Act 1993 M17;
- a registered chiropractor as defined in section 43 of the Chiropractors Act 1994 M18;
- a person registered as a member of a relevant profession within the meaning of article 2 and paragraph 1 of Schedule 3 to the Health Professions Order 2001, in the Health and Care Professions Council register; F1126...
- a person registered in the dental care professionals register established and maintained under section 36B of the Dentists Act 1984 M19 as a member of a profession complementary to dentistry specified by regulation 2 of the General Dental Council (Professions Complementary to Dentistry) Regulations 2006 M20; or
- a person registered under the Anaesthesia Associates and Physician Associates Order 2024
- “health centre” means a health centre maintained under—
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- “herbal medicinal product” means a medicinal product whose only active ingredients are herbal substances or herbal preparations (or both);
- “herbal preparation” means a preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation, and includes a comminuted or powdered herbal substance, a tincture, an extract, an essential oil, an expressed juice or a processed exudate;
- “herbal substance” means a plant or part of a plant, algae, fungi or lichen, or an unprocessed exudate of a plant, defined by the plant part used and the botanical name of the plant, either fresh or dried, but otherwise unprocessed;
- “homoeopathic medicinal product” means a medicinal product prepared from homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by—
- the European Pharmacopoeia; or
- in the absence of such a description in the European Pharmacopoeia,
- in relation to a certificate of registration or marketing authorisation for a national homoeopathic product in force in Great Britain only, the British Pharmacopoeia, or in an pharmacopoeia used officially in an country that is included in a list published by the licensing authority for this purpose;
- in relation to a certificate of registration or marketing authorisation for a national homoeopathic product in force in the whole United Kingdom or in Northern Ireland only, in the British Pharmacopoeia or in any pharmacopoeia used officially in an EEA State;
- “hospice” means an institution whose primary function is the provision of palliative care to persons resident there who are suffering from a progressive disease in its final stages;
- “hospital” includes a clinic, nursing home or similar institution;
- “immediate packaging” in relation to a medicinal product means the container or other form of packaging immediately in contact with the medicinal product;
- “import” means import, or attempt to import, into the United Kingdom, whether by land, sea or air and “imported” is to be construed accordingly;
- “inspector” means a person authorised in writing by an enforcement authority for the purposes of Part 16 (enforcement) (and references to “the enforcement authority”, in relation to an inspector, are to the enforcement authority by whom the inspector is so authorised);
- “intermediate product” means a substance which—
- has been manufactured for use in the manufacture of medicinal products; and
- is intended for further processing by a manufacturer of such products;
- “internet service” means a service made publicly available by means of the internet, which includes a service made publicly available by means of a combination of the internet and an electronic communications service or electronic communications network (within the meanings given to those expressions in section 32 of the Communications Act 2003);
- “investigational medicinal product” has the meaning given in regulation 2(1) of the Clinical Trials Regulations;
- “labelling” in relation to a container or package of medicinal products means affixing to or otherwise displaying on it a notice describing or otherwise relating to the contents (and “label” has a corresponding meaning);
- “the licensing authority” has the meaning given by regulation 6(2);
- “listed NIMAR product” means a product included in a list maintained in accordance with regulation 167B on the date it is dispatched from Great Britain to Northern Ireland;
- “local naloxone provider” is to be construed in accordance with regulation 237A(3);
- “manufacture”, in relation to a medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, a substance used as a vehicle for the purpose of administering it;
- “manufacturer's licence” has the meaning given by regulation 17(1);
- “manufacturer’s licence (MM)” means a manufacturer’s licence that relates to the manufacture or assembly of MM medicinal products specified in that licence;
- “manufacturer’s licence (POC)” means a manufacturer’s licence that relates to the manufacture or assembly of POC medicinal products specified in that licence;
- “marketing authorisation” means—
- “medicinal product subject to general sale” has the meaning given in regulation 5(1) (classification of medicinal products);
- “medical device”—
- has the meaning given in regulation 2 of the Medical Devices Regulations 2002; or
- to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 69 of those Regulations;
- “medicinal products on a general sale list” means medicinal products subject to general sale, as provided for by regulation 5(1)(a) (and related expressions are to be construed accordingly);
- “the Ministers” is to be construed in accordance with regulation 6(6) to (8);
- “MM” means modular manufacture;
- “MM control site” means the premises at which the holder of a manufacturer’s licence (MM) supervises and controls the manufacture or assembly of MM medicinal products;
- “MM master file” means a detailed description of the arrangements for the manufacture or assembly of an MM medicinal product;
- “MM medicinal product” means a medicinal product that, for reasons relating to deployment, the licensing authority determines it necessary or expedient to be manufactured or assembled in a modular unit;
- “modular unit” means a relocatable manufacturing unit;
- “naloxone product” means a medicinal product that contains naloxone or a salt, ester or stereoisomeric form of naloxone;
- “name” in relation to a medicinal product means—
- where the product has a UK marketing authorisation or traditional herbal registration, the name—
- as approved by the licensing authority in granting the authorisation or registration, or
- where that name has been varied since that approval, as so amended;
- F1159... and
- where the product has an Article 126a authorisation, the name—
- as approved by the licensing authority to appear on the packaging and any package leaflet of the product under the authorisation, or
- where that name has been varied since that approval, as so amended;
- “the Narcotic Drugs Convention” means the Single Convention on Narcotic Drugs signed by the United Kingdom on 30thMarch 1961 as amended by the Protocol Amending the Single Convention on Narcotic Drugs signed by the United Kingdom on 25th March 1972;
- “NHS dispensing practice” means the business as part of which NHS pharmaceutical services are provided by general practitioners;
- “NHS pharmaceutical services” means—
- in England, pharmaceutical services under Part 7 of the National Health Service Act 2006;
- in Wales, pharmaceutical services under Part 7 of the National Health Service (Wales) Act 2006;
- in Scotland, pharmaceutical services under Part 2 of the National Health Service (Scotland) Act 1978;
- in Northern Ireland, pharmaceutical services under Part 6 of the Health and Personal Social Services (Northern Ireland) Order 1972;
- “NHS primary dental services” means—
- in relation to England, primary dental services under the National Health Service Act 2006;
- in relation to Wales, primary dental services under the National Health Service (Wales) Act 2006;
- in relation to Scotland, dental services under the National Health Service (Scotland) Act 1978 or personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997 M25; and
- in relation to Northern Ireland, general dental services under the Health and Personal Social Services (Northern Ireland) Order 1972 or personal dental services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997 M26;
- “NHS primary medical services” means—
- in relation to England, primary medical services under the National Health Service Act 2006;
- in relation to Wales, primary medical services under the National Health Service (Wales) Act 2006;
- in relation to Scotland, primary medical services under the National Health Service (Scotland) Act 1978; and
- in relation to Northern Ireland, primary medical services under the Health and Personal Social Services (Northern Ireland) Order 1972;
- “NIMAR” means Northern Ireland MHRA authorised route;
- “nurse independent prescriber” means a person who—
- is a registered nurse or registered midwife; and
- is noted in the professional register as qualified to order drugs, medicines and appliances as a nurse independent prescriber or a nurse independent / supplementary prescriber;
- “nursing home” has the meaning given by article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
- “occupational health vaccinator” means a person who is employed or engaged by a person operating an occupational health scheme, who is an individual belonging to one of the classes of individuals specified in Part 4 of Schedule 16;
- “optometrist independent prescriber” means a person—
- who is a registered optometrist; and
- against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;
- “orphan criteria” means the criteria listed in regulation 50G(2);
- “orphan marketing authorisation” means a UK marketing authorisation granted under regulation 49(1)(a) in accordance with regulation 58C;
- “Orphan Regulation” means Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products as it has effect in EU law;
- “outer packaging” in relation to a medicinal product means any packaging into which the immediate packaging of the medicinal product is placed;
- “package” in relation to a medicinal product, includes—
- a container of the product;
- any box, packet or other article in which one or more containers of the product are or are to be enclosed; and
- any box, packet or other article in which a box, packet or other article mentioned in paragraph (b) or this paragraph is or is to be enclosed;
- “package leaflet” in relation to a medicinal product, means a leaflet that accompanies the product and contains information for the user of the product;
- “paediatric clinical trial” means a clinical trial conducted in whole or in part on persons under the age of 18 years;
- “paediatric indication” means a term of a UK marketing authorisation enabling the medicinal product to which the authorisation relates to be used by or administered to persons under the age of 18 years;
- “paediatric investigation plan” means a research and development programme with the purpose of generating data determining the conditions in which a medicinal product may be authorised to treat persons under the age of 18 years;
- “paediatric population” means that part of the population consisting of persons under the age of 18 years;
- “the Paediatric Regulation” means Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 M27;
- “parallel import licence” has the meaning given in regulation 48(2);
- “paramedic independent prescriber” means a person—
- who is a registered paramedic; and
- against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a paramedic independent prescriber;
- “periodic safety update report” or “PSUR” has the meaning given in regulation 191 (obligation on holder to submit periodic safety update reports: general requirements);
- “pharmacist” means—
- “pharmacist independent prescriber” means a person who—
- is a pharmacist; and
- is noted in the relevant register as qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;
- “the Pharmacovigilance Risk Assessment Committee” means the committee of the EMA established by Article 56(1)(aa) of Regulation (EC) No 726/2004;
- “pharmacovigilance system” means a system used by the holder of a UK marketing authorisation F1160..., traditional herbal registration or Article 126a authorisation, or by the licensing authority, to fulfil the tasks and responsibilities set out in Part 11 and designed to monitor the safety of authorised or registered medicinal products and detect any change to their risk-benefit balance;
- “pharmacovigilance system master file” means a detailed description of the pharmacovigilance system used by the holder of a UK marketing authorisation F1161..., traditional herbal registration or Article 126a authorisation with respect to one or more authorised or registered medicinal products;
- “pharmacy medicine” has the meaning given in regulation 5(5) (classification of medicinal products);
- “physiotherapist independent prescriber” means a person—
- who is a registered physiotherapist; and
- against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;
- “POC” means point of care;
- “POC control site” means the premises at which the holder of a manufacturer’s licence (POC) supervises and controls the manufacture or assembly of POC medicinal products;
- “POC master file” means a detailed description of the arrangements for the manufacture or assembly of a POC medicinal product;
- “POC medicinal product” means a medicinal product that, for reasons relating to method of manufacture, shelf life, constituents or method or route of administration, can only be manufactured at or near the place where the product is to be used or administered;
- “POC site” means a site at which the manufacture or assembly of a POC medicinal product takes place;
- “podiatrist independent prescriber” means a person—
- who is a registered podiatrist; and
- against whose name is recorded in the relevant register an annotation signifying that the person is qualified to order drugs, medicines and appliances as a podiatrist independent prescriber;
- “post-authorisation efficacy study” means any study relating to a medicinal product to which a UK marketing authorisation relates that is conducted with the aim of considering the efficacy of that product;
- “post-authorisation safety study” means any study relating to a medicinal product to which a UK marketing authorisation F1162..., traditional herbal registration or Article 126a authorisation relates that is conducted with the aim of—
- identifying, characterising or quantifying a safety hazard;
- confirming the safety profile of the medicinal product; or
- measuring the effectiveness of risk management measures;
- “prescription only medicine” has the meaning given in regulation 5(3) (classification of medicinal products);
- “product information” in relation to a medicinal product means—
- the summary of the product characteristics;
- the immediate and outer packaging; and
- the package leaflet;
- “the professional register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001 M30;
- “provider of probation services”—
- in England and Wales, has the same meaning as in Part 1 of the Offender Management Act 2007 (new arrangements for the provision of probation services); and
- in Northern Ireland, means the Probation Board for Northern Ireland;
- “provider of youth justice services” means—
- in England and Wales, a provider, other than a local authority, of the services specified in section 38(4) of the Crime and Disorder Act 1998 (local provision of youth justice services);
- in Scotland, a provider, other than a local authority, of the services in Scotland in respect of a child that most closely correspond to the services specified in section 38(4) of the Crime and Disorder Act 1998, and for these purposes “child” has the meaning given in section 199 of the Children’s Hearings (Scotland) Act 2011 (meaning of “child”); and
- in Northern Ireland, a body or other person with which or whom the Department of Justice has made arrangements for the provision of juvenile justice centres pursuant to Article 51(2) of the Criminal Justice (Children) (Northern Ireland) Order 1998 (juvenile justice centres);
- “the Psychotropic Substances Convention” means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971;
- “qualified person”, except in relation to the expression “appropriately qualified person”, means—
- a person who satisfies the requirements specified in Part 1 or 2 of Schedule 7; or
- where an application for a licence is made before 30th April 2013, in so far as the application relates to activities in respect of traditional herbal medicinal products, a person who has been engaged in activities in respect of traditional herbal medicinal products equivalent to those in Part 3 of Schedule 7 on or before 30th April 2011 and continues to be so engaged at the time when the application is made;
- “qualifying Northern Ireland goods” has the same meaning that it has in the European Union (Withdrawal) Act 2018, including any meaning defined for the purposes of that Act from time to time by regulations made under the power conferred by section 8C(6) of that Act;
- “radiation emergency” has the meaning given by regulation 2(1) of the Radiation (Emergency Preparedness and Public Information) Regulations 2019;
- “radionuclide” means a radioactive isotope;
- “radionuclide generator” means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and is to be used in a radiopharmaceutical;
- “radionuclide kit” means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration;
- “radionuclide precursor” means any radionuclide produced for the radio-labelling of another substance prior to administration, other than a radionuclide that is incorporated in or produced from a generator or is included in a radiopharmaceutical;
- “radiopharmaceutical” means a medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose;
- “registered dietitian” means a person registered in Part 4 of the Health and Care Professions Council register;
- “registered midwife” means a person registered in the Midwives Part of the professional register;
- “registered nurse” means a person registered in the Nurses Part or the Specialist Community Public Health Nurses Part of the professional register;
- “registered paramedic” means a person who is registered in Part 8 of the Health and Care Professions Council register;
- “registered pharmacy” means—
- in relation to Great Britain, premises entered in the register required to be kept under article 19 of the Pharmacy Order 2010 for the purposes of sections 74A and 74J of the Medicines Act 1968 M32; and
- in relation to Northern Ireland, premises entered in the register required to be kept under section 75 M33 of the Medicines Act 1968;
- “registered physiotherapist” means a person registered in Part 9 of the Health and Care Professions Council register;
- “registered podiatrist” means a person registered in Part 2 of the Health and Care Professions Council register;
- “registered radiographer” means a person registered in Part 11 of the Health and Care Professions Council register;
- “registrable homoeopathic medicinal product” means a homoeopathic medicinal product to which regulation 102 applies;
- “Regulation (EC) No 726/2004” means Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency , as it has effect in EU law;
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- “Regulation (EC) No 1234/2008” means Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products M34 , as it has effect in EU law;
- “the relevant EU provisions” means the provisions of legislation of the European Union relating to medicinal products for human use, except to the extent that any other enactment provides for any function in relation to any such provision to be exercised otherwise than by the licensing authority;
- “relevant European State” means an EEA State or Switzerland;
- “relevant medicinal product” has the meaning given by regulation 48;
- “the relevant register” means—
- in relation to a pharmacist—
- in Great Britain, Part 1 of the Register of pharmacists and pharmacy technicians maintained under article 19(2) of the Pharmacy Order 2010, or
- in Northern Ireland, the register maintained in pursuance of articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;
- in relation to a registered nurse or registered midwife, the professional register;
- in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989 F412...; and
- in relation to a chiropodist or podiatrist, a physiotherapist, an orthoptist , a paramedic or a radiographer, the part of the Health and Care Professions Council register relating to—
- “retail pharmacy business” means a business (other than a professional practice carried on by a doctor , any other professional practice which is an NHS dispensing practice or a professional practice carried on by a dentist) which consists of or includes the retail sale of medicinal products that are not subject to general sale;
- “risk management plan” means a detailed description of the risk management system;
- “risk management system” means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including an assessment of the effectiveness of those activities and interventions;
- “serious adverse reaction” means an adverse reaction that—
- results in a person's death;
- threatens a person's life;
- results in a person being hospitalised as an inpatient or prolongs a person's existing stay in hospital;
- results in a person's persistent or significant disability or incapacity; or
- results in a congenital anomaly or birth defect;
- “special medicinal product” means a product within the meaning of regulation 167 or any equivalent legislation in a country other than the United Kingdom;
- “substance” means any matter regardless of its origins and includes—
- human substances (such as human blood and human blood products);
- animal substances (such as micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts and blood products);
- vegetable substances (such as micro-organisms, plants, parts of plants, vegetable secretions and extracts);
- chemical substances (such as elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis); and
- gases and vapours;
- “the summary of the product characteristics” in relation to a medicinal product means—
- where the product has a UK marketing authorisation or traditional herbal registration, the summary of the product characteristics—
- as approved by the licensing authority in granting the authorisation or registration, or
- where the summary has been varied since that approval, as so amended; or
- where the product has an EU marketing authorisation, the summary of the product characteristics—
- as approved by the European Commission in granting the authorisation, or
- where the summary has been varied since that approval, as so amended;
- “supplementary prescriber” means a person who is noted in the relevant register as qualified to order drugs, medicines and appliances as a supplementary prescriber (or, in the case of a registered nurse or registered midwife, as a nurse independent/supplementary prescriber) and is—
- a pharmacist;
- a registered midwife;
- a registered nurse;
- a chiropodist, podiatrist, physiotherapist, paramedic or radiographer; F223...
- a registered optometrist; or
- a registered dietitian;
- “supplementary protection certificate” has the meaning given in section 128B(2) of the Patents Act 1977;
- “suspected” in relation to an adverse reaction means that there is at least a reasonable possibility of there being a causal relationship between a medicinal product and an adverse event;
- “therapeutic radiographer independent prescriber” means a person—
- who is a registered radiographer; and
- against whose name is recorded in the relevant register—
- an entitlement to use the title “therapeutic radiographer”; and
- an annotation signifying that the person is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;
- F424...
- “traditional herbal medicinal product” means a herbal medicinal product to which regulation 125 applies;
- “traditional herbal registration” means a traditional herbal registration granted by the licensing authority under these Regulations and—
- “THR(UK)” means such a registration in force in the whole United Kingdom;
- “THR(GB)” means such a registration in force in Great Britain only;
- “THR(NI)” means such a registration in force in Northern Ireland only;
- “UK marketing authorisation” means a marketing authorisation granted by the licensing authority under Part 5 of these Regulations or Chapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure) and—
- “UKMA(UK)” means such an authorisation , within the definition of UKMA(UK)(Category 1) or UKMA(UK)(Category 2), in force in the whole United Kingdom;
- “UKMA(GB)” means such an authorisation in force in Great Britain only;
- “UKMA(NI)” means such an authorisation in force in Northern Ireland only.
- “UKMA(UK)(Category 1)” means a marketing authorisation of the description in regulation 49(1ZB);
- “UKMA(UK)(Category 2)” means a marketing authorisation of the description in regulation 49(1ZC);
- “under the unfettered access route” means an application for—
- a UKMA(UK)(Category 2) under reduced or alternative requirements specified in Part 5 (as referred to in regulation 49(1A));
- a COR(GB) under reduced or alternative requirements specified in Part 6 (as referred to in regulation 103(1A));
- a THR(GB) under reduced or alternative requirements specified in Part 7 (as referred to in regulation 127(1A));
- “vaccine” means an antigenic substance which consists wholly or partly of—
- any micro-organisms, viruses or other organisms in any state;
- any toxins of microbial origin which have been detoxified (toxoids); or
- any extracts or derivatives of any micro-organisms or of any viruses,
being substances which, when administered to human beings, are used for the prevention of specific diseases; - “variation to the terms of a UK marketing authorisation” means any change to—
- the information provided in accordance with regulations 50 to 57 and Schedule 8; or
- the terms of the decision granting the UK marketing authorisation, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting that UK marketing authorisation, or changes to the labelling or the package leaflet connected with changes to the summary of the product characteristics,
- “withdrawal agreement” has the meaning given in section 39 of the European Union (Withdrawal Agreement) Act 2020;
- “wholesale dealer's licence” has the meaning given by regulation 18(1).
PART 2 Administration¶
9 Commission on Human Medicines¶
10 Functions of the Commission¶
11 British Pharmacopoeia Commission¶
12 Reporting to Ministers¶
13 Co-option of additional members of advisory bodies¶
14 Appointment of expert advisory groups¶
15 Delegation of functions to expert advisory groups¶
16 Further provision about advisory bodies and expert advisory groups etc¶
Schedule 2 (which makes further provision about advisory bodies and expert advisory groups, and provision about payment and expenses of expert committees appointed by the licensing authority) has effect.PART 3 Manufacture and distribution of medicinal products and active substances¶
CHAPTER 1 Interpretation¶
A17 Interpretation¶
In this Part “manufacture”, in relation to an active substance, includes any process carried out in the course of making the substance and the various processes of dividing up, packaging, and presentation of the active substance.Chapter 1A Good manufacturing practice and good distribution practice¶
B17 Regulations on good manufacturing practice¶
C17 Guidelines on good manufacturing practice and good distribution practice¶
CHAPTER 2 Manufacturing and wholesale dealing¶
Grant etc of licences¶
17 Manufacturing of medicinal products¶
17A Manufacturing of MM medicinal products¶
A person may not manufacture or assemble an MM medicinal product unless—17B Manufacturing of POC medicinal products¶
A person may not manufacture or assemble a POC medicinal product unless—18 Wholesale dealing in medicinal products¶
18A Approved country for import¶
19 Exemptions from requirement for wholesale dealer's licence¶
20 Mixing of medicines¶
21 Application for manufacturer's or wholesale dealer's licence¶
22 Factors relevant to determination of application for manufacturer's or wholesale dealer's licence¶
23 Grant or refusal of licence¶
24 Standard provisions of licences¶
25 Duration of licence¶
A licence granted under this Part remains in force until—26 General power to suspend, revoke or vary licences¶
27 Procedure where licensing authority proposes to suspend, revoke or vary licence¶
27A Effect of suspension or variation relating to modular unit or POC site¶
28 Suspension of licence in cases of urgency¶
29 Variation of licence on the application of the holder¶
29A Variation of MM master file¶
Except where regulation 27A(1) applies, the holder of a manufacturer’s licence (MM) may amend the information in the MM master file provided in accordance with paragraph 1A(2)(a), (c) and (h) to (k) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.29B Variation of POC master file¶
Except where regulation 27A(2) applies, the holder of a manufacturer’s licence (POC) may amend the information in the POC master file provided in accordance with paragraph 1B(2)(a), (b) and (g) to (j) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.30 Provision of information¶
Miscellaneous and offences¶
31 Certification of manufacturer's licence¶
F5532 Sale and supply of starting materials¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33 Offence concerning data for advanced therapy medicinal products¶
34 Offences: breach of regulations and false information and defence concerning starting materials¶
35 Penalties¶
Conditions for holding a manufacturer's licence¶
36 Conditions for manufacturer's licence¶
37 Manufacturing and assembly¶
37A Manufacturing and assembly of MM medicinal products: additional requirements¶
In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (MM) must ensure that—37B Manufacturing and assembly of POC medicinal products: additional requirements¶
In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (POC) must ensure that—38 Imports from states other than EEA States / countries other than approved countries for import ¶
39 Further requirements for manufacturer's licence¶
40 Obligation to provide information relating to control methods¶
41 Requirements as to qualified persons¶
Conditions for holding a wholesale dealer's licence¶
42 Conditions for wholesale dealer's licence¶
43 Obligations of licence holder¶
43ZA Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland¶
F119243A Requirement for wholesale dealers to decommission the unique identifier¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44 Requirement for wholesale dealers to deal only with specified persons¶
45 Requirement as to responsible persons¶
45AA Requirement as to responsible persons where licence holder imports from an approved country for import¶
45AB Register for responsible persons (import)¶
CHAPTER 3 Brokering¶
45A Brokering in medicinal products¶
45B Application for brokering registration¶
45C Procedure for determining an application for broker’s registration¶
45D Grant or refusal of broker’s registration¶
45E Criteria of broker’s registration¶
45F Provision of information¶
45G Power to suspend or vary a broker’s registration or remove a broker from the register¶
45H Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register¶
45I Suspension of a broker registration in cases of urgency¶
45J Variation of a broker’s registration on the application of the broker¶
45K Offences: breach of regulations and false information¶
45L Penalties¶
CHAPTER 4 Importation, manufacture and distribution of active substances¶
45M Criteria for importation, manufacture or distribution of active substances¶
45N Registration in relation to active substances¶
45O Requirements for registration as an importer, manufacturer or distributor of an active substance¶
45P Provision of information¶
- “R” means a person who is, or has applied to the licensing authority to become, a registered importer, manufacturer or distributor of active substances;
- “reporting year” means a period of twelve months ending on 31st March.
45Q Power to suspend or vary or remove an active substance registration¶
45R Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register¶
45S Suspension of an active substance registration in cases of urgency¶
45T Variation of an active substance registration on an application from the registered person¶
45U Offences: breach of regulations and false information¶
45V Penalties¶
PART 4 Requirement for authorisation¶
46 Requirement for authorisation¶
47 Breach of requirement¶
PART 5 Marketing authorisations¶
48 Application of this Part¶
- F1201...
- “excluded reference product” means—
- a medicinal product authorised on the basis that it was a generic medicinal product;
- a medicinal product authorised on the basis that one or more of the circumstances listed in Article 10(3) of the 2001 Directive or regulation 52(1)(b) applied; or
- a biological medicinal product authorised on the basis that it did not meet a condition for being a generic medicinal product for any of the reasons described in Article 10(4) of the 2001 Directive or regulation 53B(1);
- “generic medicinal product”, in relation to a reference medicinal product for an application for—
- a UKMA(NI) or UKMA(UK)(Category 2), has the meaning given in Article 10(2)(b) of the 2001 Directive;
- a UKMA(UK)(Category 1), means a medicinal product—
- that has the same qualitative and quantitative composition in active substances as the reference medicinal product;
- that has the same pharmaceutical form as the reference medicinal product; and
- whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies;
- “parallel import licence” means a licence that is granted by the licensing authority under this Part authorising the holder to place on the market a medicinal product imported in to the United Kingdom from an EEA State where that product—
- has been granted an EU marketing authorisation or a marketing authorisation in an EEA State under the 2001 Directive; and
- is essentially similar to a product that has been granted a UK marketing authorisation;
- “relevant medicinal product” means a medicinal product that is not—
- a registrable homoeopathic medicinal product; or
- a traditional herbal medicinal product; and
- “reference medicinal product” means—
- in relation to an application for a UKMA(NI), a medicinal product—
- authorised for sale or supply in Northern Ireland under regulation 49(1)(a), in accordance with the provisions of regulation 50; or
- in relation to which an EU marketing authorisation or a marketing authorisation granted by a member State pursuant to the 2001 Directive is or has been in force,
- F1205...
- in relation to an application for a UKMA(UK), a medicinal product—
- authorised under regulation 49(1)(a) for sale or supply in the whole of the United Kingdom, whether by virtue of one or more UK marketing authorisations, in accordance with the provisions of regulation 50,
- F1207...
Application for UK marketing authorisation¶
49 Application for grant of UK marketing authorisation or parallel import licence ¶
50 Accompanying material¶
50A Requirement for certain applications to include results of paediatric investigation plan¶
50B Agreement and modification of paediatric investigation plan¶
50C Deferral of initiation or completion of measures in paediatric investigation plan¶
50D Waiver of production of information in a paediatric investigation plan¶
50E Application for paediatric use marketing authorisation¶
50F Other applications including paediatric indications¶
50G Applications relating to orphan medicinal products¶
50H Applications relating to advanced therapy medicinal products¶
50I Applications relating to conditional marketing authorisations F1129...¶
50J Applications in relation to medicinal products containing or consisting of genetically modified organisms¶
50K Applications relating to POC medicinal products¶
51 Application for UKMA(NI) relating to generic medicinal products¶
F124251A Application for UKMA(GB) relating to generic medicinal products¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51B Application for UKMA(UK) relating to generic medicinal products¶
52 Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc¶
F124552A Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52B Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.¶
53 Application for UKMA(NI) relating to similar biological medicinal products¶
F124853A Application for UKMA(GB) relating to similar biological medicinal products¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53B Application for UKMA(UK) relating to similar biological medicinal products¶
54 Applications relating to products in well-established medicinal use¶
55 Applications relating to new combinations of active substances¶
56 Applications containing information supplied in relation to another product with consent¶
57 Obligation to update information supplied in connection with application¶
57A Obligation to update information supplied in connection with parallel import licence application¶
Consideration of application¶
58 Consideration of application¶
58A Paediatric rewards¶
58B Publication of information relating to paediatric marketing authorisations¶
58C Consideration of applications relating to orphan medicinal products¶
58D Orphan rewards¶
58E Consideration of applications relating to combined advanced therapy medicinal products¶
58F Consideration of applications relating to conditional marketing authorisations¶
58G Consideration of applications in relation to medicinal products containing or consisting of genetically modified organisms¶
59 Conditions of UK marketing authorisation or parallel import licence: general¶
60 Conditions of UK marketing authorisation or parallel import licence: exceptional circumstances¶
60A Condition as to the submitting of samples and other information to the appropriate authority ¶
- “the appropriate authority” is to be construed in accordance with section 57(7) of the Health and Social Care Act 2012;
- “appropriate documentation”, in relation to a sample of a batch submitted to the appropriate authority in accordance with the batch testing condition or pursuant to a notification under paragraph (12), means—
- any certificate issued by a laboratory in an approved country for batch testing and certification of biological medicinal products that relates to the sample of the batch submitted to the appropriate authority with that certificate; and
- such other documentation as the appropriate authority notifies the holder of the UK marketing authorisation to which the sample relates that it requires;
- “approved country list for batch testing and certification of biological medicinal products” means the list described in paragraph (5), and “approved country for batch testing and certification of biological medicinal products” means a country included in that list;
- “the batch testing condition”, in respect of a UK marketing authorisation, is a condition to the effect that, unless the batch testing exemption applies, the holder of the UK marketing authorisation—
- must submit a sample from each batch of the medicinal product that is the subject of that authorisation to the appropriate authority, together with appropriate documentation; and
- must not sell or supply, or offer to sell or supply, a medicinal product that forms part of that batch in the United Kingdom until the appropriate authority has examined—
- the sample from that batch,
- the appropriate documentation, or
- both that sample and that documentation,
and confirmed that it is satisfied that the batch is in conformity with the approved specifications in the UK marketing authorisation; and - “the batch testing exemption” means that—
- in the case of a medicinal product for sale or supply in Northern Ireland only and authorised under a UKMA(NI) or a UKMA(UK)(Category 2), a certificate—
- has been issued by a laboratory in an EEA State, and
- in the case of a product of a kind listed in Article 114(1) of the 2001 Directive, was issued in the same EEA State as that in which the batch was manufactured, and
- in the absence of such a certificate, or in the case of a medicinal product authorised for sale or supply under a UKMA(GB) or a UKMA(UK)(Category 1)—
- a certificate has been issued by a laboratory in a country other than the United Kingdom,
- an agreement has been made between that country and the United Kingdom (whether or not the agreement is solely with that country, a group of countries or an organisation of which that country is a part), and
- that agreement is to the effect that the appropriate authority will recognise that certificate in respect of the batch of the medicinal product, in place of the appropriate authority’s own examination of a sample from the batch, the appropriate documentation or both.
F127160B Submitting of samples and other information: EU marketing authorisations¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 Conditions of UK marketing authorisation: new obligations post-authorisation¶
62 Classification of UK marketing authorisation or parallel import licence¶
63 Frequency of periodic safety update reports¶
64 Duties of licensing authority in connection with determination¶
64A Obligation of licensing authority in case of change of classification¶
Validity of UK marketing authorisation¶
65 Validity of UK marketing authorisation¶
65A Validity of parallel import licence¶
65B Validity of conditional marketing authorisation¶
65C Variation of a UKMA(GB) or a UKMA(UK)(Category 1)¶
66 Application for renewal of authorisation¶
66A Application for renewal of a parallel import licence¶
66B Renewal of conditional marketing authorisation¶
67 Failure to place on the market etc¶
Revocation, variation and suspension of marketing authorisation¶
68 Revocation, variation and suspension of UK marketing authorisation or parallel import licence ¶
69 Suspension of use etc of relevant medicinal product¶
F58570 Authorisations granted under Chapter 4 of Title III of the 2001 Directive¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71 Withdrawal of medicinal product from the market¶
72 Sale etc of suspended medicinal product¶
Obligations of holder of marketing authorisation¶
73 Obligation to notify placing on the market etc¶
74 Obligation to take account of scientific and technical progress¶
74A Obligation to provide information relating to methods of manufacture and control: MM medicinal products¶
The holder of a UK marketing authorisation relating to an MM medicinal product must provide the holder of the manufacturer’s licence (MM) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (MM) and MM master file relating to the product are consistent with the marketing authorisation at all times.74B Obligation to provide information relating to methods of manufacture and control: POC medicinal products¶
The holder of a UK marketing authorisation relating to a POC medicinal product must provide the holder of the manufacturer’s licence (POC) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (POC) and POC master file relating to the product are consistent with the marketing authorisation at all times.75 Obligation to provide information relating to safety etc¶
76 Obligation in relation to product information¶
77 Record-keeping obligations¶
The holder of a marketing authorisation or parallel import licence must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of any product to which the authorisation relates.78 Obligation to ensure appropriate and continued supplies¶
The holder of a marketing authorisation must take all reasonable steps to ensure appropriate and continued supplies of the product to which the authorisation relates to pharmacies and persons authorised to supply the product so that the needs of patients in the United Kingdom are met.78A Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply¶
78B Post authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal products¶
Offences relating to specific requirements¶
79 Failure to provide information on marketing authorisations to EMA¶
80 Urgent safety restrictions¶
The holder of a UK marketing authorisation is guilty of an offence if the holder —80A Urgent safety restrictions: parallel import licences¶
The holder of a parallel import licence is guilty of an offence if the holder—Offences relating to EU marketing authorisations¶
A81 Application of regulations 89 to 94¶
Regulations 89 to 94 apply in relation to medicinal products for sale or supply in Northern Ireland (that are not in Northern Ireland by virtue of regulation 167A).F112881 Obligation to update information supplied in connection with EU application¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F112882 EU marketing authorisations: failure to notify placing on market etc¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F112883 EU marketing authorisations: failure to take account of technical and scientific progress¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F112884 EU marketing authorisations: failure to provide information as to safety etc¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F112885 EU marketing authorisations: failure to update product information¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F112886 EU marketing authorisations: breach of pharmacovigilance condition etc¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Offences relating to advanced therapy medicinal products¶
F112887 Offences in connection with risk management systems and traceability systems¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F112888 Offence concerning data for advanced therapy medicinal products¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Offences relating to the Paediatric Regulation¶
89 Offences in connection with withdrawal of product from the market¶
90 Failure to place on the market taking account of paediatric indication¶
F60091 Failure to notify results of third country clinical trials¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92 Failure of sponsor of UK paediatric clinical trial to notify results of trial¶
93 Failure to notify results of paediatric study¶
94 Failure to submit report to EMA¶
The holder of a marketing authorisation is guilty of an offence if the holder fails to submit an annual report to the EMA as required by Article 34(4) of the Paediatric Regulation.Offences relating to the safety features appearing on the packaging of medicinal products¶
F130694A Offences relating to Commission Regulation 2016/161¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .General provisions relating to offences¶
95 Offences in connection with application¶
A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a marketing authorisation for a relevant medicinal product, the person—95A Offences in connection with parallel import licence application¶
A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a parallel import licence for a relevant medicinal product, the person—96 Provision of false or misleading information¶
97 Breach of pharmacovigilance condition¶
98 General offence of breach of provision of this Part¶
99 Penalties¶
100 Persons liable¶
If a breach of regulation 95 (offences in connection with application) is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.101 Defences¶
PART 6 Certification of homoeopathic medicinal products¶
Application of Part¶
102 Application of Part¶
Application for certificate of registration and consideration of application¶
103 Application for certificate of registration¶
104 Consideration of application¶
105 Conditions of certificate of registration¶
106 Classification of certificate of registration¶
107 Validity of certificate of registration¶
108 Application for renewal of certificate¶
109 Failure to place on the market etc¶
Revocation, variation and suspension of certificate of registration¶
110 Revocation, variation and suspension of certificate of registration¶
F615111 Certificates granted under Chapter 4 of Title III of the 2001 Directive¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112 Withdrawal of homoeopathic medicinal product from the market¶
Obligations of holder of certificate of registration¶
113 Obligation to notify placing on the market etc¶
114 Obligation to take account of scientific and technical progress¶
115 Obligation to provide information relating to safety etc¶
116 Obligation in relation to product information¶
117 Record-keeping obligation¶
The holder of a certificate of registration must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of the product to which the certificate relates.118 Obligation to ensure appropriate and continued supplies¶
The holder of a certificate of registration must take all reasonable steps to ensure appropriate and continued supplies of the product to which the certificate relates to pharmacies and persons authorised to supply the product so that the needs of patients in the United Kingdom are met.Provisions relating to offences¶
119 Offences in connection with applications¶
A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a certificate of registration for a registrable homoeopathic medicinal product, the person—120 Provision of false or misleading information¶
121 General offence of breach of provision of this Part¶
122 Penalties¶
A person guilty of an offence under this Part is liable—123 Persons liable¶
If an offence under regulation 119 (offences in connection with applications) is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.124 Defences¶
PART 7 Traditional herbal registrations¶
Interpretation and application of Part¶
124A Interpretation of this Part¶
In this Part, “relevant list” means—125 Traditional herbal medicinal products¶
125A List of approved countries for traditional use of a herbal medicinal product¶
126 Addition of vitamins or minerals¶
The addition to a traditional herbal medicinal product of a vitamin or mineral does not prevent a traditional herbal registration from being granted for the product if—List of herbal substances, preparations and combinations for use in traditional herbal medicinal products¶
126A Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal products¶
Application for traditional herbal registration¶
127 Application for grant of traditional herbal registration¶
128 Accompanying material¶
129 Obligation to update information supplied in connection with application¶
Consideration of application¶
130 Consideration of application¶
130A Procedure where less than 15 years use of traditional herbal medicinal product¶
- “appropriate committee” has the same meaning as in paragraph 2(4) of Schedule 11;
- “relevant advice” means advice as to whether—
- the conditions in regulation 125, other than condition D, are met in relation to the application; and
- the licensing authority should exercise its powers under regulation 143A to establish a herbal monograph.
131 Classification of traditional herbal registration¶
Validity of traditional herbal registration¶
132 Validity of traditional herbal registration¶
133 Application for renewal of registration¶
134 Failure to place on the market etc¶
Revocation, variation and suspension of traditional herbal registration¶
135 Revocation, variation and suspension of traditional herbal registration¶
136 Revocation by licensing authority: further provisions¶
137 Procedures for revocation, variation or suspension¶
Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a traditional herbal registration, other than a proposal to vary a registration on the application of its holder.138 Suspension of use etc of traditional herbal medicinal product¶
F645139 Registrations granted under Chapter 4 of Title III of the 2001 Directive¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140 Withdrawal of traditional herbal medicinal product from the market¶
141 Sale etc of suspended traditional herbal medicinal product¶
Obligations of holder of traditional herbal registration¶
142 Obligation to notify placing on the market etc¶
143 Obligation to take account of scientific and technical progress¶
143A Establishment of herbal monographs¶
144 Obligation following new herbal monograph¶
145 Obligation to provide information relating to safety etc¶
146 Obligation in relation to product information¶
147 Record-keeping obligations¶
The holder of a traditional herbal registration must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of any product to which the registration relates.148 Obligation to ensure appropriate and continued supplies¶
The holder of a traditional herbal registration must take all reasonable steps to ensure appropriate and continued supplies of the product to which the registration relates to pharmacies and persons authorised to supply the product so that the needs of patients in the United Kingdom are met.148A Urgent safety restrictions¶
Offences relating to traditional herbal registrations¶
149 Urgent safety restrictions¶
150 Offences in connection with applications¶
A person is guilty of an offence if in the course of an application for the grant, renewal or variation of a traditional herbal registration for a traditional herbal medicinal product the person—151 Provision of false or misleading information¶
152 General offence of breach of provision of this Part¶
153 Penalties¶
A person guilty of an offence under this Part is liable—154 Persons liable¶
If an offence under regulation 150 (offences in connection with applications) is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.155 Defences¶
PART 8 Article 126a authorisations¶
156 Article 126a authorisations¶
157 Requests from EU member States ¶
158 Application of these Regulations¶
The following provisions of Part 5 (marketing authorisations) apply to an Article 126a authorisation as they apply to a marketing authorisation—PART 9 Borderline products¶
159 Provisional determination¶
160 Challenge to provisional determination¶
161 Written representations procedure¶
162 Oral representations procedure¶
163 Final determination without representations¶
164 Effect of final determination¶
165 Determination in other cases¶
Nothing in this Part prevents the licensing authority from determining that a product is a medicinal product in relation to these Regulations without following the procedures in this Part when it thinks it appropriate.166 Offences relating to borderline products¶
PART 10 Exceptions to requirement for marketing authorisation etc¶
Exceptions¶
167 Supply to fulfil special patient needs¶
167A NIMAR supply to Northern Ireland¶
167B List of NIMAR products¶
167C Early Access to Medicines Scheme: establishment and licensing authority functions¶
167D EAMS scientific opinions ceasing to have effect¶
167E EAMS medicinal products: manufacture, assembly, importation, distribution and supply¶
167F Advertising of EAMS medicinal products¶
167G EAMS medicinal products: pharmacovigilance¶
167H Early Access to Medicines Scheme: data collection¶
168 Use of non-prescription medicines in the course of a business¶
169 Mixing of general sale medicinal products¶
170 Record-keeping requirements¶
170A MM medicinal products: pharmacovigilance requirements¶
170B POC medicinal products: pharmacovigilance requirements¶
171 Exempt advanced therapy medicinal products¶
172 Parallel import licences¶
173 Exemption for certain radiopharmaceuticals¶
Regulation 46 (requirement for authorisation) does not apply where a radiopharmaceutical is prepared—174 Supply in response to spread of pathogenic agents etc¶
The prohibitions in regulation 46 (requirement for authorisation) do not apply where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis in response to the suspected or confirmed spread of—174A Conditions of temporary authorisations under regulation 174¶
Offences¶
175 Offences relating to exceptions¶
176 Penalties and supplementary provision about offences¶
PART 11 Pharmacovigilance¶
177 Application of this Part and interpretation¶
- “co-ordination group” means the group of that name established under Article 27 of the 2001 Directive;
- “Eudravigilance database” means the database and data-processing network set up and maintained by the EMA under Article 24 of Regulation (EC) No 726/2004;
- “Implementing Regulation” means Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council.
- “infringement notice” has the meaning given to it in regulation 206 (infringement notices);
- “relevant competent authorities” means the competent authority of each EEA state other than the United Kingdom which has granted in relation to a medicinal product—
- an authorisation in accordance with Chapter 1 of Title III to the 2001 Directive (marketing authorization);
- an authorisation in accordance with Chapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure);
- a registration in accordance with Chapter 2a of Title III to the 2001 Directive (traditional use registration for herbal medicinal products); or
- an authorisation in accordance with Article 126a of the 2001 Directive;
- “relevant post-authorisation safety study” means a post-authorisation safety study which—
- is non-interventional;
- is initiated, managed or financed by the holder voluntarily or pursuant to conditions imposed under regulation 59 (conditions of a UK marketing authorisation: general) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation); and
- involves the collection of safety data from patients or health care professionals; F679...
- “signal” means, in relation to a UKMA(GB) , UKMA(UK)(Category 1) or THR(GB), information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action; and
- “UK web-portal” has the meaning given in regulation 203 (obligations on licensing authority in relation to national medicines web-portal).
Obligations on licensing authority in relation to pharmacovigilance¶
178 General obligations of the licensing authority¶
The licensing authority must—179 Obligation on licensing authority to operate pharmacovigilance system¶
180 Obligation on licensing authority to audit pharmacovigilance system¶
181 Delegation of obligations under this Part¶
Obligations on holders in relation to pharmacovigilance system¶
182 Obligation on holder to operate pharmacovigilance system¶
183 Exception to obligation to operate risk management system¶
184 Obligation on holder to audit pharmacovigilance system¶
Recording, reporting and assessment of pharmacovigilance data¶
185 Recording obligations on the licensing authority¶
The licensing authority must record all suspected adverse reactions to medicinal products that—186 Reporting obligations on the licensing authority¶
186A ¶
The licensing authority must collaborate with the World Health Organisation in matters of pharmacovigilance, and must in particular—187 Recording obligations on holders¶
188 Reporting obligations on holders¶
- F716...
- F716...
- “the specified time period” means—
- in the case of serious adverse reactions, the period of 15 days beginning on the day following the day on which the follow up information became known to the holder; and
- in the case of non-serious adverse reactions, the period of 90 days beginning on the day following the day on which the follow up information became known to the holder.
Signal detection¶
189 Signal detection: licensing authority obligations¶
190 Signal detection: holder obligation¶
Periodic Safety Update Reports¶
191 Obligation on holder to submit periodic safety update reports: general requirements¶
- “authorisation” means a UK marketing authorisation or an Article 126a authorisation;
- “the holder” means the holder of a UK marketing authorisation or an Article 126a authorisation; and
- “product” means a product to which a UK marketing authorisation or Article 126a authorisation relates.
191A Obligation on holder of a parallel import licence to submit periodic safety update reports¶
192 Obligation on holder to submit periodic safety update reports: derogation from general requirements¶
- “authorisation or registration” means a marketing authorisation to which paragraph (1)(a) applies or a traditional herbal registration;
- “the holder” means the holder of a marketing authorisation to which paragraph (1)(a) applies or of a traditional herbal registration; and
- “product” means a product to which a marketing authorisation referred to in paragraph (1)(a) or a traditional herbal registration relates.
193 Harmonisation of PSUR frequency or date of submission¶
194 Responding to a single assessment of PSUR under Article 107e of the 2001 Directive¶
195 Obligation on licensing authority to assess PSURs F400...¶
- “EU reference date” has the meaning given in regulation 193(6);
- “EU single assessment procedure” has the meaning given in regulation 194(5); and
- “relevant changes” in relation to a medicinal product means—
- new risks,
- risks that have changed, or
- changes to the risk-benefit balance.
Urgent action and major safety review ¶
196 Urgent action¶
196A Major safety review by the licensing authority¶
197 EU urgent action procedure¶
Post-authorisation safety studies¶
198 Post-authorisation safety studies: general provisions¶
199 Submission of draft study protocols for required studies¶
200 Amendment to study protocols for required studies¶
201 Submission and evaluation of final study reports for required studies¶
202 Follow-up of final study reports¶
Medicinal products subject to additional monitoring¶
202A Licensing authority power in relation to medicinal products subject to additional monitoring¶
Transparency and communications¶
203 Obligations on licensing authority in relation to national medicines web-portal¶
204 Obligation on licensing authority in relation to public announcements¶
205 Obligations on holders in relation to public announcements¶
Further obligations in respect of pharmacovigilance activities¶
205A Further obligations in respect of pharmacovigilance activities¶
Guidance in respect of pharmacovigilance¶
205B Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies¶
Enforcement¶
206 Infringement notices¶
207 Offences¶
208 False and misleading information¶
A person is guilty of an offence if the person provides information to the licensing authority or the EMA, pursuant to an obligation in this Part, but that information is false or misleading in a material particular.209 Penalties¶
F1378210 Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210A Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A ¶
211 Persons liable¶
If an offence under regulation 207(1) (offences) F1382... is committed by a person acting as employee or agent, the employer or principal of that person is guilty of the same offence and is liable to be proceeded against and punished accordingly.Transitional arrangements¶
212 Transitional arrangements¶
Regulations F782... 198, 199, 200, 201, 202 and 210 are subject to the transitional provisions set out in Schedule 33 (transitional arrangements: pharmacovigilance).C11PART 12 Dealings with medicinal products¶
CHAPTER 1 Interpretation¶
213 Interpretation¶
- “approved country health professional” means a person who is practising in a profession included in the list published under regulation 214(6A) in a country that is included in that list in relation to that profession;
- F1091...
- “the Common Services Agency” means the Common Services Agency for the Scottish Health Service established under section 10 of the National Health Service (Scotland) Act 1978 M35;
- F90...
- “the dental care professionals register” means the register established and maintained under section 36B of the Dentists Act 1984 M36;
- “Council Directive 2005/36/EC” means Council Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications;
- F784...
- F92...
- F266...
- “food” includes—
- beverages;
- confectionery;
- articles and substances used as ingredients in the preparation of food; and
- any manufactured substance—
- to which there has been added any vitamin, and
- which is advertised as available and for sale to the general public as a dietary supplement;
- “health authority” means—
- F11...
- in relation to Wales, a Local Health Board established under section 11 of the National Health Service (Wales) Act 2006 M37;
- in relation to Scotland, a Health Board constituted under section 2(1)(a) of the National Health Service (Scotland) Act 1978 M38; and
- in relation to Northern Ireland, the Department of Health in Northern Ireland;
- “health care” means services for or in connection with the prevention, diagnosis or treatment of disease;
- “health prescription” means a prescription issued by a doctor, dentist, supplementary prescriber, nurse independent prescriber, optometrist independent prescriber, pharmacist independent prescriber, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber , paramedic independent prescriber or community practitioner nurse prescriber under—
- in England, the National Health Service Act 2006;
- in Wales, the National Health Service (Wales) Act 2006;
- in Scotland, the National Health Service (Scotland) Act 1978; and
- in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972 M39;
- F12...
- “independent clinic”—
- in relation to England, means an establishment of either of the following kinds—
- a walk-in centre, in which one or more medical practitioners provides services of a kind which, if provided in pursuance of the National Health Services Act 2006, would be provided as primary medical services under Part 4 of that Act, or
- a surgery or consulting room in which a medical practitioner who provides no services in pursuance of the National Health Services Act 2006 provides medical services of any kind (including psychiatric treatment), except where such medical services are provided only under arrangements made on behalf of the patients by—
- their employer,
- a government department or any executive agency of any government department,
- a prison or other establishment in which patients are held under custody, other than pursuant to any provision under the Mental Health Act 1983 M40, or
- an insurance provider with whom the patients hold an insurance policy, other than an insurance policy which is solely or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability or infirmity,
and where two or more medical practitioners use different parts of the same premises as a surgery or consulting room, or use the same surgery or consulting room at different times, each of the medical practitioners shall be regarded as carrying on a separate independent clinic unless they practise together;
- in relation to Wales, has the meaning given by section 2(4) of the Care Standards Act 2000 M41;
- in relation to Scotland, has the meaning given by section 10F(2) of the National Health Service (Scotland) Act 1978 M42; and
- in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 M43;
- “independent hospital”—
- in relation to England, means a hospital as defined by section 275 of the National Health Service Act 2006 that is not a health service hospital as defined by that section;
- in relation to Wales, has the meaning given by section 2(2) of the Care Standards Act 2000;
- in relation to Scotland, has the meaning given by section 10F(2) of the National Health Act 1978; and
- in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
- “independent medical agency”—
- in relation to England, means an undertaking (not being an independent hospital) which consists of or includes the provision of services by medical practitioners, and the term “undertaking” in this definition includes any business or profession and—
- in relation to a public or local authority includes the exercise of any functions of that authority, and
- in relation to any other body of persons, whether corporate or unincorporated, includes any of the activities of that body;
- in relation to Wales, has the meaning given by section 2(5) of the Care Standards Act 2000;
- in relation to Scotland means an undertaking which is neither an independent clinic nor an undertaking comprised in a hospital and which consists of or includes the provision of services, other than in pursuance of the National Health Service (Scotland) Act 1978, by a medical practitioner; and
- in relation to Northern Ireland, has the meaning given by article 2(2) of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
- “integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the National Health Service Act 2006;
- “local authority” has the same meaning as in section 2B of the National Health Service Act 2006;
- “Maritime and Coastguard Agency” means the executive agency of that name of the Department for Transport;
- “maximum daily dose” or “MDD”, in relation to a product for internal use, means the maximum quantity of the substance contained in the amount of the product that it is recommended should be taken or administered in any period of 24 hours;
- “maximum dose” or “MD”, in relation to a product for internal use, means the maximum quantity of the substance contained in the amount of the product that it is recommended should be taken or administered at any one time;
- “NHS body” means—
- the Common Services Agency;
- a health authority;
- a special health authority;
- an integrated care board;
- NHS England;
- F14...
- an NHS trust; or
- an NHS foundation trust;
- “NHS foundation trust” has the meaning given by section 30(1) of the National Health Service Act 2006;
- “NHS trust”—
- in relation to England, means an NHS trust established under section 25(1) of the National Health Service Act 2006;
- in relation to Wales, means an NHS trust established under section 18(1) of the National Health Service (Wales) Act 2006;
- in relation to Scotland, means an NHS trust established under section 12A of the National Health Service (Scotland) Act 1978 M44; and
- in relation to Northern Ireland, means a Health and Social Care trust established under Article 10 of the Health and Personal Social Services (Northern Ireland) Order 1991 M45;
- “nursing home” has the meaning given by article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 M46;
- “parenteral administration” means administration by breach of the skin or mucous membrane;
- “patient group direction” or “PGD” means a written direction that relates to the sale or supply and to the administration of a description or class of medicinal product and that—
- is signed—
- by a doctor or dentist and by a pharmacist, and
- by any other person who may be required to sign it in the circumstances specified for its use in any provision of this Part; and
- relates to sale or supply and to administration to persons generally (subject to any exclusions that may be specified in the PGD);
- F15...
- “prison service” means—
- in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952 M47);
- in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989 M48); and
- in relation to Northern Ireland, the Department of Justice exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953 M49);
- “product subject to special medical prescription” means a prescription only medicine that has been designated as subject to special medical prescription in accordance with paragraph (3);
- “Public Health Agency” means the Regional Agency for Public Health and Social Well-being established by section 12 of the Health and Social Care (Reform) Act (Northern Ireland) 2009;
- F1119...
- “registered chiropodist” means a person who is registered in Part 2 of the Health and Care Professions Council register;
- “registered dental hygienist” means a person registered under that title in the dental care professionals register;
- “registered dental therapist” means a person registered under that title in the dental care professionals register;
- F232...
- “registered occupational therapist” means a person who is registered in Part 6 of the Health and Care Professions Council register;
- “registered orthoptist” means a person who is registered in Part 7 of the Health and Care Professions Council register;
- “registered orthotist and prosthetist” means a person who is registered in Part 10 of the Health and Care Professions Council register;
- “registered pharmacy technician” means a person registered in Part 2 of the Register of pharmacists and pharmacy technicians established and maintained under article 19(1) and (2) of the Pharmacy Order 2010;
- F279...
- F233...
- F234...
- “registered provider”—
- in England, in relation to an independent hospital, independent clinic, an independent medical agency, a dental clinic or a dental practice means the person who is registered as a service provider under Chapter 2 of Part 1 of the Health and Social Care Act 2008 M52 in respect of regulated activities (within the meaning of that Part) carried on in that hospital, clinic, agency, dental clinic or dental practice;
- in Wales, in relation to an independent hospital, an independent clinic or an independent medical agency, means the person who is registered under Part 2 of the Care Standards Act 2000 as the person who carries on the hospital, clinic or agency;
- in Scotland, in relation to an independent hospital, an independent clinic or an independent medical agency, means the person who is registered under section 10P of the National Health Service (Scotland) Act 1978 M53; and
- in Northern Ireland, in relation to an independent hospital, an independent clinic, a nursing home or an independent medical agency, means the person who is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the person who carries on the hospital, clinic, nursing home or agency;
- F235...
- “registered speech and language therapist” means a person who is registered in Part 12 of Health and Care Professions Council register;
- “relevant manager”—
- in England, means—
- a person, other than the registered provider, who is registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008 as the manager of an independent hospital, independent clinic, an independent medical agency, a dental clinic or a dental practice, or
- if there is no such person, but the registered provider has appointed a person to manage the hospital, clinic, agency, dental clinic or dental practice, that person;
- in Wales, means—
- a person, other than the registered provider, who is registered under Part 2 of the Care Standards Act 2000 as the manager of an independent hospital, an independent clinic or an independent medical agency, or
- if there is no such person, but the registered provider has appointed a person to manage the hospital, clinic or agency, that person;
- in Scotland, means a person, other than the registered provider, who was identified as an individual who is to manage an independent hospital, an independent clinic or an independent medical agency on the application for registration of that clinic, hospital or agency under section 10P of the National Health Service (Scotland) Act 1978; and
- in Northern Ireland, means—
- a person, other than the registered provider, who is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 as the manager of an independent hospital, an independent clinic, a nursing home or an independent medical agency, or
- if there is no such person, but the registered provider has appointed a person to manage the hospital, clinic, nursing home or agency, that person;
- “relevant prescriber” means any of the following—
- a doctor;
- a dentist;
- a supplementary prescriber;
- a nurse independent prescriber;
- a pharmacist independent prescriber;
- a community practitioner nurse prescriber;
- a physiotherapist independent prescriber;
- a podiatrist independent prescriber;
- a therapeutic radiographer independent prescriber;
- a paramedic independent prescriber;
- an optometrist independent prescriber; and
- an approved country health professional;
- “repeatable prescription” means a prescription that contains a direction that it may be dispensed more than once;
- “school” means—
- a maintained school (as defined in section 20(7) of the School Standards and Framework Act 1998);
- a maintained nursery school (as defined in section 22(9) of the School Standards and Framework Act 1998);
- an independent school (as defined in section 463 of the Education Act 1996) entered on a register of independent schools kept under section 158 of the Education Act 2002;
- an independent educational institution (as defined in section 92(1) of the Education and Skills Act 2008) entered on a register of independent educational institutions kept under section 95 of that Act;
- a school approved under section 342 of the Education Act 1996 (non-maintained special schools);
- a pupil referral unit (as defined in section 19 of the Education Act 1996);
- an alternative provision Academy (as defined in section 1C(3) of the Academies Act 2010);
- a school as defined in section 135(1) of the Education (Scotland) Act 1980; and
- a school as defined in Article 2(2) of the Education and Libraries (Northern Ireland) Order 1986.
- “sell” means sell by retail (and “sale” has a corresponding meaning);
- “special health authority” means—
- in relation to England, a Special Health Authority established under section 28 of the National Health Service Act 2006;
- in relation to Wales, a Special Health Authority established under section 22 of the National Health Service (Wales) Act 2006;
- in relation to Scotland, a Special Health Board constituted under section 2(1)(b) of the National Health Service (Scotland) Act 1978 M54; and
- in relation to Northern Ireland, a special health and social care agency established under Article 3 of the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990 M55;
- “supply” means supply in circumstances corresponding to retail sale;
- “unit preparation” means a preparation, including a mother tincture, that—
- is prepared by a process of—
- solution,
- extraction, or
- trituration,
with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert dilutent; and - is used—
- in that diluted form, or
- where applicable, by impregnating tablets, granules, powders or other inert substances,
for the purpose of being administered to human beings.
- “vaccine group direction” means a written direction that relates to the supply and administration of a vaccine and that—
- is signed by any person who may be required to sign it in the circumstances specified for its use in regulation 235A; and
- relates to supply and to administration to eligible persons in accordance with regulation 235A (subject to any exclusions that may be specified in the vaccine group direction).
- “the United Kingdom Health Security Agency” means the executive agency of that name of the Department of Health and Social Care.
CHAPTER 2 Sale and supply of medicines¶
Prescription only medicines¶
214 Sale or supply of prescription only medicines¶
215 Prescribing and administration by supplementary prescribers¶
- “clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—
- the patient to whom the plan relates;
- the doctor or dentist who is a party to the plan; and
- any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;
- “health record” has the meaning given by section 68(2) of the Data Protection Act 1998 M56.
216 Exceptions to regulation 215¶
217 Requirements for prescriptions: general¶
217A Requirements for prescriptions to be dispensed in an EEA state F402...¶
- “B” means a person who is an appropriate practitioner for the purposes of regulation 214(3) to (5B);
- “P” means a person who is the patient of B.
217B Original pack dispensing ¶
217BA Original pack dispensing: Northern Ireland¶
217C Original pack dispensing: medicinal products containing a relevant substance ¶
217CA Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland¶
218 Requirements for prescriptions: approved country health professional ¶
219 Electronic prescriptions¶
- “advanced electronic signature” has the meaning given within Article 3(11) of Regulation (EU) No 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market;
- “electronic prescription service” means the service of that name which is managed by NHS England, the body corporate established under section 1H of the National Health Service Act 2006.
219A Electronic Prescriptions: approved country health professionals¶
Medicines not subject to general sale¶
220 Sale or supply of medicinal products not subject to general sale¶
General sale medicines¶
220B Sale or supply of items dispensed by a pharmacist who is absent or treated as absent¶
221 Sale or supply of medicinal products subject to general sale¶
222 Sale of medicinal products from automatic machines¶
A person may not sell or offer for sale a medicinal product by means of an automatic machine if the product is not subject to general sale.222A Assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses¶
222B Hub and spoke arrangements: sharing of data between different businesses¶
CHAPTER 3 Exemptions¶
Exemptions relating to supply in specific circumstances¶
223 Exemptions for doctors and dentists etc¶
224 Emergency sale etc by pharmacist: prescriber unable to provide prescription¶
225 Emergency sale etc by pharmacist: at patient's request¶
| Prescription only medicine | Maximum quantity |
|---|---|
A prescription only medicine that— | The smallest pack that the pharmacist has available for sale or supply. |
| An oral contraceptive. | A quantity sufficient for a full treatment cycle. |
| An antibiotic for oral administration in liquid form. | The smallest quantity that will provide a full course of treatment. |
| A controlled drug within the meaning of Schedule 4 or 5 of the Misuse of Drugs Regulations 2001 or Schedule 4 or 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002. | Five days' treatment. |
| Any other prescription only medicine. | 30 days' treatment. |
226 Emergency sale etc by pharmacist: pandemic diseases¶
226A Sale etc by a pharmacist in accordance with a serious shortage protocol¶
227 Exemption for sale or supply in hospitals¶
228 Exemptions relating to prescriptions given by certain health professionals¶
229 Exemption for supply by national health service bodies and local authorities ¶
230 Exemption for supply etc under a PGD to assist doctors or dentists¶
231 Exemption for supply etc under a PGD by independent hospitals etc¶
232 Exemption for supply etc under a PGD by dental practices and clinics: England and Wales¶
233 Exemption for supply etc under a PGD by person conducting a retail pharmacy business¶
234 Exemption for supply etc of products under a PGD to assist the police etc¶
235 Exemption for sale, supply or administration by certain persons¶
235A Exemption for supply or administration of certain medicines used for vaccination¶
- “a public health agency” means—
- Public Health Scotland in respect of Scotland;
- Public Health Wales in respect of Wales;
- the UK Health Security Agency in respect of England;
- the Public Health Agency in respect of Northern Ireland;
- “relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence);
- “senior manager” means a person who plays a significant role (irrespective of whether other individuals also do so) in—
- the making of decisions about how the whole or a substantial part of the activities of the body in question are to be managed or organised, or
- the actual managing or organising of the whole or a substantial part of those activities.
Exemptions in relation to specific kinds of product¶
236 Products consisting of or containing aloxiprin, aspirin or paracetamol¶
Regulation 214(1) does not apply to a medicinal product that is a prescription only medicine by virtue of paragraph 1(e) of Schedule 1 (non-effervescent aloxiprin, aspirin or paracetamol) if the quantity of the product sold or supplied to a person at any one time does not exceed 100 tablets or capsules.237 Products consisting of or containing pseudoephedrine salts or ephedrine base or salts¶
237A Appropriate suppliers of naloxone products¶
238 Administration of certain medicines in an emergency¶
Regulation 214(2) does not apply to the administration of a prescription only medicine specified in Schedule 19 where this is for the purpose of saving life in an emergency.239 Administration of smallpox vaccine¶
240 Radioactive medicinal products¶
- “IRME practitioner” means—
- in relation to a medical exposure in England and Wales and Scotland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2017;
- in relation to a medical exposure in Northern Ireland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;
- “medical exposure” has the same meaning—
- in England and Wales and Scotland as in the Ionising Radiation (Medical Exposure) Regulations 2017;
- in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;
- “radioactive substance” has the same meaning—
- in England and Wales and Scotland as in the Ionising Radiation (Medical Exposure) Regulations 2017;
- in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.
241 Exemptions in respect of certain herbal remedies¶
242 Exemption for medicinal products at high dilution¶
243 Exemption for certain homoeopathic medicinal products¶
Other exemptions¶
244 Exemption in cases involving another's default¶
245 Exemption in case of forged prescription¶
Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription if the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.246 Exemption where requirements for prescriptions not met¶
Regulation 214(1) does not apply to the sale or supply of a prescription only medicine otherwise than in accordance with a prescription given by an appropriate practitioner if—247 Exemption for supply in the event or anticipation of pandemic disease¶
F1615247A Protocols relating to coronavirus and influenza vaccinations and immunisations¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .248 Exemption for certain collection and delivery arrangements¶
CHAPTER 4 Miscellaneous provisions, offences and disqualification¶
Miscellaneous provisions¶
249 Restrictions on persons to be supplied with medicinal products¶
250 Exceptions to regulation 249¶
- “additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register;
- “contact lens specialist” means a person who is a registered dispensing optician and against whose name particulars of the contact lens speciality have been entered in—
- the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989; or
- the register of visiting dispensing opticians from relevant European States maintained under section 8B(1)(b) of that Act.
251 Compliance with standards specified in certain publications¶
252 Compliance with standards specified in certain publications: supplementary¶
253 Pharmacy records¶
254 Prohibitions concerning traceability of treatment with advanced therapy medicinal products¶
255 Offences relating to dealings with medicinal products¶
F1391255A Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F1392255B Exception to Article 25 of Commission Regulation 2016/161: health care institutions¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F1393255C Offences relating to Commission Regulation 2016/161: management of the repository system¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Disqualification¶
256 Disqualification on conviction¶
PART 12A Sale of medicines to the public at a distance¶
256ZA Application of Part¶
This part applies to Northern Ireland only.256A Interpretation¶
- “common logo” means the common logo that is required to be clearly displayed on websites offering medicinal products for sale at a distance to the public in accordance with the requirements laid down in the implementing acts adopted by the Commission under Article 85c(3) of the 2001 Directive;
- “information society services” means information society services as defined in Article 1(2) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services;
- “the list” means the list of persons who are entitled to supply medicinal products by information society services that is maintained on the website of the licensing authority;
- F813...
- “website of the EMA” means the website of the EMA that—
- gives explicit information to the viewer on the website of the licensing authority containing information on persons authorised or entitled to supply medicinal products at a distance in Northern Ireland;
- provides information on the purpose of the common logo;
- provides background information about the risks related to medicinal products supplied illegally to the public by means of information society services;
- provides information on Community legislation applicable to falsified medicinal products;
- contains a hyperlink to the website of the licensing authority.
- “website of the licensing authority” means a website of the licensing authority providing information on—
- the national legislation applicable to the offering of medicinal products for sale at a distance to the public by information society services;
- the differences between Northern Ireland and EEA States regarding classification of medicinal products and the conditions for their supply;
- the purpose of the common logo;
- the list of persons offering medicinal products for sale at a distance by means of information society services as well as their website addresses;
- background information about the risks related to medicinal products supplied illegally to the public by means of information society services;
- a hyperlink to the website of the EMA;
256B Person who may sell medicinal products by information society services¶
256C Notification requirements for sellers of medicinal products at a distance¶
256D Procedure for listing persons who may supply medicinal products at a distance¶
256E Removal of a person’s entry from the list¶
The licensing authority may remove a person’s entry from the list if—256F Provision of information to the licensing authority ¶
256G Grant or refusal to list a person¶
256H Conditions to be met by a person entered on the list¶
256I Power to suspend, vary or remove a person’s entry on the list¶
256J Procedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list¶
256K Suspension of a person’s entry on the list in cases of urgency¶
256L Variation of a person’s entry on the list on the application of that person¶
256M Offences: breach of regulations and false information¶
256N Penalties¶
PART 13 Packaging and leaflets¶
CHAPTER 1 ¶
Requirements for packaging and package leaflets relating to medicinal products¶
257 Packaging requirements: general¶
257AA Packaging requirements: variation in accordance with regulation 68(11I)¶
257AB Transitional arrangements¶
The information specified in paragraph 18B of Schedule 24 is not required to appear on the packaging of a medicinal product released for sale or distribution before 1st January 2025, unless the product has been re-packaged or relabelled after that date.F1397257A Packaging Requirements: medicinal products required to bear safety features¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F1398257B Transitional Arrangements¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .257C Packaging requirements: advanced therapy medicinal products¶
257CA Packaging requirements: POC medicinal products¶
257D Guidance as to packaging and package leaflets¶
257E Regulation-making power as to certain forms of labelling¶
The Ministers may by regulations require the use of certain forms of labelling of a medicinal product in order to make it possible to ascertain—258 Packaging requirements: specific provisions¶
259 Packaging requirements: information for blind and partially sighted patients¶
260 Package leaflets¶
261 Use of pictures and symbols etc¶
262 Labelling requirements for radionuclides¶
263 Leaflets relating to radionuclides¶
264 Homoeopathic medicines¶
265 Additional requirements for traditional herbal medicinal products¶
266 Language requirements etc¶
267 Submission of mock-ups of packaging and leaflets to licensing authority¶
Enforcement and offences¶
268 Offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc¶
268A Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc¶
269 Offences relating to packaging and package leaflets in Great Britain: other persons¶
269A Offences relating to packaging and package leaflets in Northern Ireland: other persons¶
270 Non-compliance with requirements of this Part¶
271 Offences: penalties¶
A person who is guilty of an offence under regulation 268, 268A, 269, 269A or 270 is liable—CHAPTER 2 ¶
Requirements relating to child safety¶
272 Interpretation¶
In this Chapter—- “appropriate practitioner” means any of the persons described as appropriate practitioners in relation to any prescription only medicine in regulation 214(3), (5) and (6);
- “regulated medicinal product” means a medicinal product containing aspirin, paracetamol or more than 24mg of elemental iron, in the form of tablets, capsules, pills, lozenges, pastilles, suppositories or oral liquids, but does not include—
- effervescent tablets containing not more than 25% of aspirin or paracetamol by weight;
- medicinal products in sachets or other sealed containers which hold only one dose;
- medicinal products which are not intended for retail sale or for supply in circumstances corresponding to retail sale; or
- medicinal products which are for export only.
273 Child resistant containers for regulated medicinal products¶
274 Exemptions from regulation 273¶
275 Colouring of aspirin and paracetamol products for children¶
The sale or supply of a medicinal product containing aspirin or paracetamol of any colour other than white is prohibited if—276 Offences¶
PART 14 Advertising¶
CHAPTER 1 General¶
277 Interpretation¶
- “court” means the High Court or, in Scotland, the Court of Session;
- “holder of a temporary authorisation” means, where there is in force in relation to a medicinal product an authorisation by the licensing authority on a temporary basis under regulation 174 (but not an authorisation, certificate or registration as mentioned in regulation 281(1)(a) to (e)), the person who is responsible for placing that product on the market in the United Kingdom;
- “injunction” (except in regulation 313) includes an interim injunction;
- “OFCOM” means the Office of Communications;
- “person qualified to prescribe or supply medicinal products” includes—
- persons who, in the course of their profession or in the course of a business, may lawfully—
- prescribe medicinal products,
- sell medicinal products by retail, or
- supply medicinal products in circumstances corresponding to retail sale; and
- employees of such persons;
- “publication”, in relation to an advertisement, means the dissemination or issue of that advertisement—
- orally;
- in writing;
- by means of an electronic communications network within the meaning of the Communications Act 2003 M64; or
- in any other way,
and includes causing or procuring such publication by or on behalf of another person, and “publish” has a corresponding meaning.
278 Functions of the Ministers¶
A function of the Ministers under this Part may be exercised by either of them acting alone or both of them acting jointly (and references in this Part to “the Ministers” are to be read accordingly).CHAPTER 2 Requirements relating to advertising¶
General¶
279 Products without a marketing authorisation etc¶
280 General principles¶
281 Duties of authorisation holders and registration holders¶
Advertising to the public¶
282 Application of regulations 283 to 292¶
Regulations 283 (products for the purpose of inducing abortions) to 292 (exception for approved vaccination campaigns) apply to advertisements wholly or mainly directed at members of the public283 Products for the purpose of inducing abortions¶
A person may not publish an advertisement that is likely to lead to the use of a medicinal product for the purpose of inducing an abortion.284 Prescription only medicines¶
284A Medicines with differing classification status in Great Britain and Northern Ireland¶
In the case of a medicinal product for sale or supply in Great Britain where the product concerned is not a prescription only medicine in Great Britain but is either—285 Narcotic and psychotropic substances¶
286 Material relating to diagnosis¶
287 Material about effects of medicinal product¶
288 Material about status of medicinal product¶
A person may not publish an advertisement relating to a medicinal product that suggests that—289 Recommendations by scientists etc¶
A person may not publish an advertisement relating to a medicinal product that refers to a recommendation by—290 Advertisements directed at children¶
A person may not publish an advertisement relating to a medicinal product that contains any material that is directed principally at children.291 Form and content of advertisement¶
291A Campaigns relating to the suspected or confirmed spread of pathogenic agents etc.¶
292 Exception for approved vaccination campaigns¶
Regulations 284 (prescription only medicines), 285 (narcotic and psychotropic substances) and 287(4)(b) (material about effects of medicinal products) do not apply to an advertisement as part of a vaccination campaign that—Prohibition of supply to the public for promotional purposes¶
293 Prohibition of supply to the public for promotional purposes¶
Advertising to persons qualified to prescribe or supply etc¶
294 General requirements¶
295 Abbreviated advertisements¶
296 Exception for advertisements intended as a reminder¶
Regulations 291 (form and content of advertisement) and 294 (general requirements) do not apply to an advertisement relating to a medicinal product if the advertisement is intended solely as a reminder of the product and consists solely of—297 Written material accompanying promotions¶
298 Free samples for persons qualified to prescribe or supply medicinal products¶
299 Medical sales representatives¶
300 Inducements and hospitality¶
Homoeopathic medicinal products¶
301 Advertisements for registered homoeopathic medicinal products¶
Traditional herbal medicinal products¶
302 Advertisements for traditional herbal medicinal products¶
A person may not publish an advertisement relating to a herbal medicinal product to which a traditional herbal registration relates unless it contains—Offences¶
303 Offences¶
CHAPTER 3 Monitoring of Advertising¶
Scrutiny by Ministers¶
304 Requirement to provide copy advertisement¶
305 Invitation to make representations about compatibility¶
306 Decision about compatibility¶
307 Corrective statement¶
308 Offences¶
Complaints to Ministers¶
309 Complaints to Ministers: duty to consider¶
310 Complaints to Ministers: power to refer¶
Injunctions¶
311 Application for injunction¶
312 Application for injunction: accuracy of factual claim¶
313 Grant of injunction: publication of decision and corrective statement¶
Complaints to OFCOM¶
314 Complaints to OFCOM¶
- “S4C Digital” means the television service provided in digital form and known as S4C Digital; and
- “Welsh Authority” means the authority whose name is, by virtue of section 56(1) of the Broadcasting Act 1990 M68, Sianel Pedwar Cymru.
General¶
315 Public interest etc¶
In exercising the functions conferred on them by this Chapter, the Ministers, the court and OFCOM must have regard, in particular, to the public interest.316 Civil proceedings¶
In exercising the functions conferred on them by this Chapter, the Ministers may institute civil proceedings in their own name.PART 15 British Pharmacopoeia¶
317 British Pharmacopoeia and compendia¶
318 Lists of names¶
319 Other documents¶
320 Supplementary provisions¶
321 Specified publications¶
PART 16 Enforcement¶
C3322 Validity of decisions and proceedings¶
323 Enforcement in England, Wales and Scotland¶
324 Enforcement in Northern Ireland¶
C6325 Rights of entry¶
C6326 Application for warrant¶
C6327 Powers of inspection, sampling and seizure¶
C6328 Regulation 327: supplementary¶
C6329 Application of sampling procedure to substance or article seized under this Part¶
C6330 Analysis of samples: other cases¶
331 Findings and reports of inspections¶
331A Guidelines on inspections¶
C7332 Restrictions on disclosure of information¶
C7333 Protection for inspectors¶
C7334 Supplementary provisions and offences¶
PART 17 Miscellaneous and general¶
Provisions relating to offences¶
C7335 Contravention due to fault of another person¶
C7336 Warranty as defence¶
C7337 Offences in relation to warranties and certificates¶
C7338 Offences by bodies corporate and partnerships¶
Prosecutions¶
C7339 Prosecutions¶
General¶
340 Presumptions¶
341 Decisions under these Regulations¶
342 Time limits for provision of information etc¶
C8343 Service of documents¶
344 Payment of expenses by Ministers¶
344A Modifications to deal with serious shortages¶
344B Regulation making powers¶
Immunity from civil liability¶
345 Immunity from civil liability¶
345A Obligation on licensing authority to maintain list of medicinal products to which derogations have applied¶
Review¶
346 Review¶
Transitional provisions, savings, amendments, repeals and revocations¶
347 Transitional provisions and savings¶
Schedule 32 contains transitional provisions and savings.347A Transitional provision in relation to EU exit¶
Schedule 33A contains transitional provision in relation to the EU Exit Regulations.347B Transitional provision relating to the Windsor Framework¶
348 Amendments to existing law¶
Schedule 34 contains amendments to existing law.349 Repeals and revocations¶
Schedule 35 contains repeals and revocations.SCHEDULES
SCHEDULE 1 ¶
Further provisions for classification of medicinal products
Regulation 5
PART 1 Descriptions of certain medicinal products to be available only on prescription¶
PART 2 Descriptions of certain medicinal products to be available only from a pharmacy¶
SCHEDULE 2 ¶
Supplementary provision relating to advisory bodies and expert advisory groups
Regulation 16
Terms of appointment¶
Facilities and proceedings¶
Payment and expenses¶
Status¶
SCHEDULE 2A ¶
Modifications of Commission Directive 2003/94/EC
Regulations 8(1) and B17(3)
| Provision of Commission Directive 2003/94/EC | Modification subject to which that provision is to be read |
|---|---|
| Article 1 (scope) | The reference to— (a) “Article 40 of Directive 2001/83/EC” is to be read as a reference to “regulation 17 of the Human Medicines Regulations 2012”; and (b) “Article 13 of Directive 2001/20/EC” is to be read as a reference to “regulation 36 of the Medicines for Human Use (Clinical Trials) Regulations 2004”. |
| Article 2 (definitions) | In the definition of— (a) “medicinal product”, the reference to “Article 1(2) of Directive 2001/83/EC” is to be read as a reference to “regulation 2 of the Human Medicines Regulations 2012”; (b) “investigational medicinal product”, the reference to “Article 2(d) of Directive 2001/20/EC” is to be read as a reference to “regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004”; (c) “manufacturer” the reference to “Article 40(1) and (3) of Directive 2001/83/EC or the authorisation referred to in Article 13(1) of Directive 2001/20/EC” is to be read as a reference to “regulation 17(1) of the Human Medicines Regulations 2012 or the authorisation referred to in regulation 36(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004”; (d) “qualified person” the reference to “Article 48 of Directive 2001/83/EC or in Article 13(2) of Directive 2001/20/EC” is to be read as a reference to “regulation 41 of the Human Medicines Regulations 2012 or regulation 43 of the Medicines for Human Use (Clinical Trials) Regulations 2004”. |
| Article 3(1) (inspections) | The reference to— (a) “for Article 111(1) of Directive 2001/83/EC” is to be read as a reference to “Part 16 of the Human Medicines Regulations 2012 (enforcement)”; (b) “Article 15(1) of Directive 2001/20/EC” is to be read as a reference to “Part 8 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (enforcement)”; (c) “the Member States”, is to be read as a reference to “the licensing authority”; (d) “Member States shall” is to be read as a reference to “The licensing authority may”; (e) “published by the Commission, of Community procedures on inspections and exchanges of information” is to be read as if after it there were inserted “or any guidance published by the licensing authority to replace that Commission guidance”. |
| Article 3(2) (inspections) | The reference to— (a) “competent authorities” is to be read as a reference to “licensing authority”; (b) “the second paragraph of Article 47 of Directive 2001/83/EC” to the end is to be read as a reference to “regulation C17(1)(a) of the Human Medicines Regulations 2012, or which applies by virtue of regulation C17(2) of those Regulations”. |
| Article 4(2) (conformity with good manufacturing practice) | The reference to— (a) “third countries” is to be read as a reference to “country other than the United Kingdom”; (b) “Community” is to be read as a reference to “licensing authority”. |
| Article 5 (compliance with marketing authorisation) | The reference to— (a) “Article 9(2) of Directive 2001/20/EC” in both places it appears is to be read as a reference to “regulation 17 of the Medicines for Human Use (Clinical Trials) Regulations 2004”; (b) “competent authorities” in both places it appears is to be read as a reference to “licensing authority”. |
| Article 9 (documentation) | The reference in— (a) paragraph (1) to “Article 51(3) of Directive 2001/83/EC” is to be read as a reference to “paragraph 15(1) of Schedule 7 to the Human Medicines Regulations 2012”; (b) paragraph (2) to “competent authorities” is to be read as a reference to “licensing authority”. |
| Article 11 (quality control) | The reference in paragraph (2)— (a) to “point (b) of Article 20 of Directive 2001/83/EC” is to be read as a reference to “paragraph 3 or 17 of Schedule 4 to the Human Medicines Regulations 2012”; (b) to “Article 9(2) of Directive 2001/20/EC” is to be read as a reference to “regulation 17 of the Medicines for Human Use (Clinical Trials) Regulations 2004”; The reference in paragraph (4)— (a) to “Member State” is to be read as a reference to “United Kingdom”; (b) to “competent authority” is to be read as a reference to “licensing authority”; |
| Article 12(4) (work contracted out) | The reference to— (a) “competent authorities” is to be read as a reference to “licensing authority”; (b) “for Article 111 of Directive 2001/83/EC and Article 15(1) of Directive 2001/20/EC” is to be read as a reference to “Part 16 of the Human Medicines Regulations 2012 or Part 8 of the Medicines for Human Use (Clinical Trials) Regulations 2004”. |
| Article 13 (complaints, product recall and emergency unblinding) | The reference to “Article 123 of Directive 2001/83/EC” is to be read as a reference to “Part 5 of the Human Medicines Regulations 2012”. |
SCHEDULE 3 ¶
Applications for licences under Part 3
Regulation 21(1)
Manufacturer's licences¶
Manufacturer’s licences (MM)¶
Manufacturer’s licence (POC)¶
Manufacturers' licence relating to import¶
Wholesale dealer's licences¶
- “the responsible person” means the person who has the functions described in regulation 45(2);
- “the responsible person (import)” means the person who has the functions described in regulation 45AA(4).
All licences¶
SCHEDULE 4 ¶
Standard provisions of licences under Part 3
Regulation 24
PART 1 Manufacturer's licence relating to manufacture and assembly¶
Part 1A Manufacturer’s licence (MM)¶
Part 1B Manufacturer’s Licence (POC)¶
PART 2 Manufacturer's licence relating to the import of medicinal products from a state other than an EEA State / Country other than an Approved Country for Import¶
- “British approved name” means the name which appears in the current edition of the list prepared by the British Pharmacopoeia Commission under regulation 318 (British Pharmacopoeia: lists of names);
- “international non-proprietary name” means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name and in respect of which the Director-General of the World Health Organisation has given notice to that effect in the World Health Organisation Chronicle; and
- “monograph name” means the name or approved synonym which appears at the head of a monograph in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or a foreign or international compendium of standards and “current” in this definition means current at the time the notice is sent to the licensing authority.
PART 3 Manufacturer's licence relating to exempt advanced therapy medicinal products¶
PART 4 Wholesale dealer's licence¶
All wholesale dealer's licences¶
Wholesale dealer's licence relating to special medicinal products¶
- “British approved name” means the name which appears in the current edition of the list prepared by the British Pharmacopoeia Commission under regulation 318 (British Pharmacopoeia- lists of names);
- “international non-proprietary name” means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name and in respect of which the Director-General of the World Health Organisation has given notice to that effect in the World Health Organisation Chronicle; and
- “monograph name” means the name or approved synonym which appears at the head of a monograph in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or a foreign or international compendium of standards, and “current” in this definition means current at the time the notice is sent to the licensing authority.
Wholesale dealer's licence relating to exempt advanced therapy medicinal products¶
SCHEDULE 5 ¶
Review upon oral representations
Regulation 27; Schedule 11paragraphs 11(3), 13(3),23(4) and 30(4)
Application of this Schedule¶
Appointment of reviewers¶
Procedure before hearing¶
Procedure at hearing¶
Procedure following hearing¶
SCHEDULE 6 ¶
Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products
Regulations 36(3) and 42(3)
PART 1 Manufacturer's licences¶
PART 2 Wholesale dealer's licences¶
SCHEDULE 7 ¶
Qualified persons
Regulation 41
PART 1 Qualification requirements for qualified person¶
PART 2 Qualified persons with long experience¶
PART 3 Obligations of qualified person¶
SCHEDULE 7A ¶
Information to be provided for registration as an importer, manufacturer or distributor of active substances
Regulation 45N(5)(b)
SCHEDULE 8 ¶
Material to accompany an application for a UK marketing authorisation
Regulation 50(1)
PART 1 General requirements¶
PART 2 Summary of the product characteristics¶
The summary of the product characteristics must contain the following information in the following order—
SCHEDULE 8A ¶
Material to accompany an application for a parallel import licence
Regulation 50(1A)
SCHEDULE 8B ¶
Modifications of Annex I to the 2001 Directive
Regulation 8(1)
| Provision of Annex I | Modification subject to which that provision is to be read |
|---|---|
| Paragraph (1) of the Introduction and general principles | The reference to “Articles 8 and 10(1)” is to be read as a reference to regulation 50 of the Human Medicines Regulations 2012. |
| Paragraphs (1) and (2) of the Introduction and general principles | If the licensing authority has published guidelines under regulation 50(5B)(a) of the Human Medicines Regulations 2012, the reference to “the rules governing medicinal products in the European Community, Volume 2B, Notice to applicants, medicinal products for human use, presentation and content of the dossier, Common Technical Document” is to be read as a reference to that guidance. |
| Paragraph (4) of the Introduction and general principles | If the licensing authority has published guidelines under regulation 50(5B)(b) of the Human Medicines Regulations 2012, the reference to “the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and the European Medicines Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of the rules governing medicinal products in the European Community” is to be read as a reference to those guidelines. |
| Paragraph (6) of the Introduction and general principles | The reference to “the requirements of Commission Directive 91/356/EEC laying down the principles of and guidelines of Good Manufacturing Practice for medicinal products for human use” is to be read as a reference to the Good Manufacturing Practice Directive, as defined in regulation 8(1) of the Human Medicines Regulations 2012. |
| Paragraph (6) of the Introduction and general principles | If the licensing authority has published principles and guidelines under regulation C17(1) of the Human Medicines Regulations 2012, the reference to “the principles and guidelines on GMP published by the Commission in the rules governing medicinal products in the European Community, Volume 4” is to be read as a reference to those principles and guidelines. |
| Paragraph (8) of the Introduction and general principles | References to “the European Community” are to be read as references to the United Kingdom. |
| Paragraph (8) of the Introduction and general principles | The references to “Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use” are to be read as references to the Medicinal Products for Human Use (Clinical Trials) Regulations 2004. |
| Paragraph (9) of the Introduction and general principles | The reference to “Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances and 88/320/EEC on the inspection and verification of good laboratory practice” is to be read as a reference to the Good Laboratory Practice Regulations 1999. |
| Paragraph (10) of the Introduction and general principles | The reference to “Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulation and administrative provisions of the Member States regarding the protection of animals for experimental and other scientific purposes” is to be read as a reference to the Animals (Scientific Procedures) Act 1986. |
| Paragraph (11) of the Introduction and general principles | The paragraph is to be read as follows: “In order to monitor the benefit/risk assessment, any new information not in the original application and all pharmacovigilance information shall be submitted to the licensing authority. After a marketing authorisation has been granted, any change to the data in the dossier shall be submitted to the licensing authority in accordance with the requirements of Schedule 10A to the Human Medicines Regulations 2012, as well as the requirements of Schedule 12A to those Regulations.” |
| Part I, paragraph 1.2, fourth paragraph | This paragraph is to be read as follows: “Annexed to the administrative data shall be copies of the manufacturing authorisation as defined in regulation 17 of the Human Medicines Regulations 2012.” |
| Part I, paragraph 1.3.1 | The reference to “Article 11” is to be read as a reference to Part 2 of Schedule 8 to the Human Medicines Regulations 2012. |
| Part I, paragraph 1.3.2 | The reference to “Title V” is to be read as a reference to Part I3 of the Human Medicines Regulations 2012, and the references to Articles 63 and 59 are to be read as references to regulations 260 and 266 of the Human Medicines Regulations 2012. |
| Part I, paragraph 1.3.4 | This paragraph is to be read as omitted. |
| Part I, paragraph 1.4 | The reference to “Article 12.2” is to be read as a reference to paragraph 11 of Schedule 8 to the Human Medicines Regulations 2012. |
| Part I, paragraph 2, first paragraph | The reference to “Article 12” is to be read as a reference to paragraph 11 of Schedule 8 to the Human Medicines Regulations 2012. |
| Part I, paragraph 3.2(5), first paragraph | The reference to a “Member State” is to be read as including the United Kingdom. |
| Part I, paragraph 3.2(5), second paragraph | The references to “the national pharmacopoeia of a Member State” are to be read as including references to the British Pharmacopoeia. |
| Part I, paragraph 3.2(6) | The reference to “the pharmacopoeia of a Member State” is to be read as including a reference to the British Pharmacopoeia. |
| Part I, paragraph 3.2(12) | The words “which is required by Community legislation” are to be read as omitted. |
| Part I, paragraph 3.2.1.2 | If the licensing authority has published guidelines under regulation 50(5B)(c) of the Human Medicines Regulations 2012, the reference to “guidelines published by the Agency” is to be read as a reference to those guidelines. |
| Part I, paragraph 3.2.2.1, second paragraph | The reference to “Article 8(3)(c)” is to be read as a reference to paragraph 3 of Schedule 8 to the Human Medicines Regulations 2012. |
| Part I, paragraph 3.2.2.1, second paragraph, first indent | The reference to “the national pharmacopoeia of one of the Member States” is to be read as including the British Pharmacopoeia. |
| Part I, paragraph 3.2.2.1, fifth paragraph | The reference to “any Member State” is to be read as a reference to the United Kingdom and the reference to “the Member States” is to be read as a reference to the United Kingdom. |
| Part I, paragraph 3.2.2.3(a) | The reference to “Article 8(3)(d)” is to be read as a reference to paragraph 5 of Schedule 8 to the Human Medicines Regulations 2012. |
| Part I, paragraph 4.2.2, fifth paragraph | The reference to “this Directive” is to be read as a reference to the Human Medicines Regulations 2012. |
| Part I, paragraph 5.2(a) | The reference to “the clinical particulars provided pursuant to Articles 8(3)(i) and 10(1)” is to be read as a reference to those particulars provided pursuant to paragraph 10 of Schedule 8 to, and regulations 51A, 52A, 53A and 54 to 56 of, the Human Medicines Regulations 2012. |
| Part I, paragraph 5.2(c) | The references to “the European Community” are to be read as references to the United Kingdom. |
| Part I, paragraph 5.2(c), fifth paragraph | The reference to “Directive 2001/20/EC and implementing detail guidelines” is to be read as a reference to the Medicinal Products for Human Use (Clinical Trials) Regulations 2004. |
| Part I, paragraph 5.2.1, second paragraph | The reference to “Article 10(1)(a)” is to be read as a reference to regulation 51A of the Human Medicines Regulations 2012. |
| Part II, paragraph 1, first paragraph | The reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 54 of the Human Medicines Regulations 2012. |
| Part II, paragraph 2(a) | The reference to “Article 10(1)(a)(i)” is to be read as a reference to regulation 56 of the Human Medicines Regulations 2012. |
| Part II, paragraph 2(b) | The reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 51A of the Human Medicines Regulations 2012. |
| Part II, paragraph 4, first paragraph | The first sentence is to be read as omitted and the words “in accordance with regulation 53A of the Human Medicines Regulations 2012” are to be read as added at the end of the second sentence. |
| Part II, paragraph 5, first paragraph | The reference to “Article 10(1)(b)” is to be read as a reference to regulation 55 of the Human Medicines Regulations 2012. |
| Part II, paragraph 6, first paragraph | The reference to “Article 22” is to be read as a reference to regulation 60 of the Human Medicines Regulations 2012. |
| Part III, paragraph 1.1(a), first indent | The reference to “Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EC as regards medical devices incorporating stable derivatives of human blood or blood plasma” is to be read as a reference to the Medical Devices Regulations 2002. |
| Part III, paragraph 1.1(a), third indent | The reference to “the Agency or the competent authority” is to be read as a reference to the licensing authority. |
| Part III, paragraph 1.1(a), fourth indent | This indent is to be read as omitted. |
| Part III, paragraph 1.1(b) | The reference to “Article 109, as amended by Directive 2002/98/EC” is to be read as a reference to the Blood Safety and Quality Regulations 2005. |
| Part III, paragraph 1.1(b)(3), second paragraph | The reference to “medicinal products referred to in Article 2 of Directive 2001/20/EC of the European Parliament and of the Council relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use” is to be read as a reference to investigational medicinal products. |
| Part III, paragraph 1.1.(c), second indent | This indent is to be read as follows: “The Plasma Master File is subject to a scientific and technical evaluation by the licensing authority.” |
| Part III, paragraph 1.1(c), fourth indent | This indent is to be read as follows: “Changes subsequently introduced to the terms of a Plasma Master File must follow the variation procedure in Schedule 10A to the Human Medicines Regulations 2012.” |
| Part III, paragraph 1.1(c), final indent | This indent is to be read as omitted. |
| Part III, paragraph 1.2(c), first indent | The references to “a competent authority” and to “the Agency” are to be read as references to the licensing authority and the final two sentences are to be read as omitted. |
| Part III, paragraph 1.2(c), second indent | The reference to “the Community” is to be read as a reference to the United Kingdom. |
| Part III, paragraph 1.2(c), third indent | This indent is to be read as follows: “Changes in the content of a Vaccine Antigen Master File must follow the variation procedure in Schedule 10A to the Human Medicines Regulations 2012.” |
| Part III, paragraph 1.2(c), fourth indent | This indent is to be read as omitted. |
| Part III, paragraph 1.2(c), fifth indent | This indent is to be read as omitted. |
| Part III, paragraph 2.1 | The reference to “applications based on Articles 6(2) and 9” is to be read as a reference to applications in relation to radionuclide generators, radionuclide kits, radionuclide precursors and radiopharmaceuticals. |
| Part III, paragraph 2.2, fourth paragraph | The reference to “Council Directives 87/18/EEC and 88/320/EEC” is to be read as a reference to the Good Laboratory Practice Regulations 1999. |
| Part III, paragraph 3, second paragraph | The reference to “Article 15” is to be read as a reference to regulation 103 of the Human Medicines Regulations 2012, the reference to “Article 14(1)” is to be read as a reference to regulation 102 of the Human Medicines Regulations 2012 and the words “referred to in Article 16(1)” are to be read as “which are not registerable homoeopathic medicinal products”. |
| Part III, paragraph 3(a) | The reference to “an official pharmacopoeia of a Member State” is to be read as including the British Pharmacopoeia and any pharmacopoeia used officially in a country that is included in a list published by the licensing authority for that purpose, and the reference to “the traditional names used in each Member State” is to be read as including the traditional name used in the United Kingdom. |
| Part III, paragraph 3(b), final paragraph | The reference to “an official pharmacopoeia of a Member State” is to be read as including the British Pharmacopoeia. |
| Part III, paragraph 3, penultimate paragraph | The reference to “Article 14(1)” is to be read as a reference to regulation 102 of the Human Medicines Regulations 2012. |
| Part III, paragraph 5, first indent | The reference to “an orphan medicinal product in the meaning of Regulation (EC) No 141/2000” is to be read as a reference to a medicinal product to which the orphan criteria are claimed to apply. |
| Part III, paragraph 5, second indent | The reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 54 of the Human Medicines Regulations 2012 and the reference to “Article 5” is to be read as a reference to regulation 167 of the Human Medicines Regulations 2012. |
| Part IV, paragraph 1, first paragraph | The reference to “point (a) of Article 2(1) of Regulation (EC) No 1394/2007” is to be read as a reference to regulation 2A of the Human Medicines Regulations 2012. |
| Part IV, paragraph 2 | This paragraph is to be read as omitted. |
| Part IV, paragraph 3.1, second paragraph | The reference to “Directive 2004/23/EC” is to be read as a reference to the Human Fertilisation and Embryology Act 1990and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the reference to “Directive 2002/98/EC” is to be read as a reference to the Blood Safety and Quality Regulations 2005. |
| Part IV, paragraph 3.3.2.1(a) | The reference to “Directive 2004/23/EC” is to be read as a reference to the Human Fertilisation and Embryology Act 1990 and the Human Tissue (Quality and Safety for Human Application) Regulations 2007. |
| Part IV, paragraph 3.4.1, heading | The reference to “devices as referred to in Article 7 of Regulation (EC) No 1394/2007” is to be read as a reference to medical devices, bio-materials, scaffolds or matrices. |
| Part IV, paragraph 3.4.2, heading | The reference to “Article 2(1)(d) of Regulation (EC) No 1394/2007” is to be read as a reference to regulation 2A(10) of the Human Medicines Regulations 2012. |
| Part IV, paragraph 3.4.2(c) | The reference to “Commission Directive 2003/32/EC” is to be read as a reference to the Medical Devices Regulations 2002. |
| Part IV, paragraph 3.4.2(d) | The reference to “Directive 93/42/EEC or Directive 90/385/EEC” is to be read as a reference to the Medical Devices Regulations 2002. |
| Part IV, paragraph 3.4.2, final paragraph | The first sentence is to be read as follows: “The applicant shall make available on request of the licensing authority any information related to the assessment by the notified body which has carried out the assessment referred to in point (d) of this section.” |
SCHEDULE 8C ¶
Material to accompany an application for a UK marketing authorisation under the unfettered access route
Regulation 50(1)
SCHEDULE 9 ¶
Undertakings by non- United Kingdom manufacturers
Regulation 50(4)
SCHEDULE 9A ¶
Meaning of terms used in the orphan criteria and in regulation 58D
Regulation 50G(4)
1 Prevalence of a condition in the United Kingdom ¶
2 Potential for return on investment¶
3 Existence of other methods of diagnosis, prevention or treatment¶
4 Increased safety or effectiveness and clinical superiority¶
- “clinically superior”, in relation to a medicinal product, means that it is shown to provide a significant therapeutic or diagnostic advantage over and above that provided by an authorised orphan medicinal product in one or more of the following ways—
- greater efficacy;
- greater safety in a substantial portion of the target population, as evidenced where appropriate through comparative clinical trials; or
- in exceptional cases, where neither greater safety nor greater efficacy has been shown, a demonstration that the medicinal product otherwise makes a major contribution to diagnosis or to patient care;
- “similar active substance” means an identical active substance, or an active substance with the same principal molecular structural features, but not necessarily all of the same molecular structural features, and which acts via the same mechanism, however, in the case of advanced therapy medicinal products, for which the principal molecular structural features cannot be fully defined, the similarity between two active substances is to be assessed on the basis of the biological and functional characteristics;
- “similar medicinal product” means a medicinal product containing a similar active substance or substances as contained in a currently authorised orphan medicinal product, and which is intended for the same therapeutic indication.
SCHEDULE 10 ¶
National homoeopathic products
Regulations 50(6)(g) and 64(5)(b)
Meaning of “national homoeopathic product”¶
General requirements for application¶
Requirement to submit safety data¶
Exceptions to requirement to submit safety data¶
Requirement to submit efficacy data¶
SCHEDULE 10A ¶
Variations to a UK marketing authorisation
Regulation 65C(2)
1 Interpretation¶
In this Schedule—- “change of, or addition of a new, route of administration”, in relation to parenteral administration, includes any change or addition as between intra-arterial, intra-venous, intramuscular, subcutaneous and any other route;
- “extension of a UK marketing authorisation” or “extension” means a variation which consists of—
- a change to one or more active substances that involves—
- replacement of a chemical active substance by a different salt, ester, complex or derivative, with the same therapeutic moiety, where the efficacy and safety characteristics are not significantly different,
- replacement by a different isomer, a different mixture of isomers, of a mixture by an isolated isomer (for example, racemate by a single enantiomer), where the efficacy and safety characteristics are not significantly different,
- replacement of a biological active substance with one of a slightly different molecular structure where the efficacy and safety characteristics are not significantly different, with the exception of changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza,
- modification of the vector used to produce the antigen or the source material, including a new master cell bank from a different source, where the efficacy and safety characteristics are not significantly different,
- a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy and safety characteristics are not significantly different, or
- change to the extraction solvent or the ratio of herbal drug to herbal drug preparation where the efficacy and safety characteristics are not significantly different; or
- a change to strength, pharmaceutical form and route of administration that involves—
- change of bioavailability,
- change of pharmacokinetics, for example change in rate of release,
- change or addition of a new strength or potency,
- change or addition of a new pharmaceutical form, or
- change or addition of a new route of administration;
- “holder” means UK marketing authorisation holder;
- “major variation of type II” means a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned namely—
- variations related to the addition of a new therapeutic indication or to the modification of an existing one;
- variations related to significant modifications of the summary of product characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance findings;
- variations related to changes outside the range of approved specifications, limits or acceptance criteria;
- variations related to substantial changes to the manufacturing process, formulation, specifications or impurity profile of the active substance or finished medicinal product which may have a significant impact on the quality, safety or efficacy of the medicinal product;
- variations related to modifications in the manufacturing process or sites of the active substance for a biological medicinal product;
- variations related to the introduction of a new design space or the extension of an approved one, where the design space has been developed in accordance with international scientific guidelines; or
- variations related to changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
- “minor variation of type IA” means a variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned namely—
- variations of purely administrative nature that are related to the identity and contact details of—
- the holder,
- the manufacturer or supplier of any starting material, reagent, intermediate, active substance used in the manufacturing process or finished product;
- variations related to the identity, location and contact details of the qualified person for pharmacovigilance, or the location of the pharmacovigilance system master file;
- variations related to the deletion of any manufacturing site, including for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place;
- variations related to minor changes to an approved physico-chemical test procedure, where the updated procedure is demonstrated to be at least equivalent to the former test procedure, appropriate validation studies have been performed and the results show that the updated test procedure is at least equivalent to the former;
- variations related to changes made to the specifications of the active substance or of an excipient in order to comply with an update of the relevant monograph of the European Pharmacopoeia or of the British Pharmacopoeia, where the change is made exclusively to comply with the pharmacopoeia and the specifications for product specific properties are unchanged;
- variations related to changes in the packaging material not in contact with the finished product, which do not affect the delivery, use, safety or stability of the medicinal product;
- variations related to the tightening of specification limits, where the change is not a consequence of any commitment from previous assessment to review specification limits and does not result from unexpected events arising during manufacture;
- “minor variation of type IB” means a variation which is not a minor variation of type IA, a major variation of type II nor an extension; and
- “urgent safety restriction” means an interim change in the terms of the UK marketing authorisation due to new information having a bearing on the safe use of the medicinal product.
2 Classification of variations¶
3 Licensing authority recommendation on unclassified variations¶
4 Variations leading to the revision of product information¶
Where a variation leads to the revision of the summary of product characteristics, labelling or the package leaflet, the revision must be considered by the licensing authority as part of that variation.5 Grouping of variations¶
6 Notification procedure for minor variations of type IA¶
7 Notification procedure for minor variations of type IB¶
8 Prior approval procedure for major variations of type II¶
9 Elements to be submitted¶
An application or notification under this Schedule must include—10 Measures to close the procedures specified in paragraphs 6 to 8¶
Where reference is made to this paragraph, the licensing authority must take the following measures—11 Extensions of marketing authorisations¶
12 Human influenza vaccines¶
13 Pandemic situation with respect to human influenza¶
14 Urgent safety restrictions¶
15 Amendments to the decision granting the marketing authorisation¶
16 Implementation of variations¶
17 Continuous monitoring¶
Where requested to do so by the licensing authority, the holder must supply to the licensing authority without delay any information related to the implementation of a given variation.SCHEDULE 11 ¶
Advice and representations
Regulations 58(5);59(7); 60(11);66(8); 68(12); 104(4);105(9); 108(8); 110(9);130(11); 133(8); and 137
PART 1 General procedures¶
Application of this Part¶
Requirement to consult the appropriate committee¶
Exceptions to requirement to consult¶
Provisional opinion against authorisation¶
Opportunity to make representations¶
Written representations¶
Oral representations¶
Other decisions of the appropriate committee¶
Decision of licensing authority¶
Right to review after paragraph 10 notification¶
Licensing authority decisions in other cases¶
Right to review or representations after paragraph 12 notification¶
PART 1A Paediatric Decisions¶
13A Application of this Part¶
This Part applies to a proposed decision by the licensing authority—13B Opportunity to make representations¶
13C Written representations¶
13D Oral representations¶
13E Other decisions of the appropriate committee¶
13F Decision of licensing authority¶
13G Right to review after paragraph 13F notification¶
PART 2 Type II variation applications, complex variation applications and new excipient variation applications¶
Application of this Part¶
Opportunity to make representations¶
Written representations¶
Oral representations¶
Other decisions of the appropriate committee¶
Decision of licensing authority following report¶
Right to review after paragraph 22 notification¶
PART 3 Referral to the appropriate committee for traditional herbal registrations¶
Application of this Part¶
Opportunity to make representations¶
Written representations¶
Oral representations¶
Other decisions of the appropriate committee¶
Decision of licensing authority following report¶
Right to review after paragraph 29 notification¶
PART 4 Exceptions to Schedule¶
SCHEDULE 12 ¶
Material to accompany an application for a traditional herbal registration
Regulation 128(1)
PART 1 General requirements¶
PART 2 Summary of the product characteristics¶
The summary of the product characteristics must contain the following information in the following order—
SCHEDULE 12A ¶
Further provision as to the performance of pharmacovigilance activities
Regulation 205A
PART 1 Pharmacovigilance system master file¶
1 Structure of the pharmacovigilance system master file¶
2 Content of the pharmacovigilance system master file¶
The pharmacovigilance system master file must, as a minimum, contain—3 Content of the Annex to the pharmacovigilance system master file¶
The pharmacovigilance system master file must have an Annex containing the following documents—4 Maintenance of the pharmacovigilance system master file¶
5 Form of the documents contained in the pharmacovigilance system master file¶
6 Subcontracting¶
7 Availability and location of the pharmacovigilance system master file¶
PART 2 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders¶
8 Quality system¶
9 Performance indicators¶
PART 3 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders¶
10 Management of human resources¶
11 Compliance management¶
12 Record management and data retention¶
13 Audit¶
PART 4 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority¶
14 Management of human resources¶
15 Compliance management¶
The licensing authority must establish specific procedures and processes in order to achieve the following objectives—16 Record management and data retention¶
17 Audit¶
PART 5 Use of terminology, formats and standards¶
18 Use of internationally agreed terminology, formats and standards¶
The licensing authority may publish a list of which of the internationally agreed—PART 6 Transmission of reports of suspected adverse reactions¶
19 Individual case safety reports¶
Individual case safety reports must be used for reporting to the licensing authority suspected adverse reactions to a medicinal product that occur in a single patient at a specific point in time.20 Content of the individual case safety report¶
21 Format of electronic transmission of suspected adverse reactions¶
Holders must use the formats and terminology specified in the list published under paragraph 18 for the electronic transmission of suspected adverse reactions, if the licensing authority has published a list under that paragraph.PART 7 Risk management plans¶
22 Content of the risk management plan¶
23 Summary of the risk management plan¶
24 Updates of the risk management plan¶
25 Format of the risk management plan¶
The risk management plan must be in the following format—PART 8 Periodic safety update reports¶
26 Content of periodic safety update reports¶
27 Format of periodic safety update reports¶
PART 9 Post-authorisation safety studies¶
28 Scope and interpretation¶
- “start of data collection” means the date on which information on the first study subject is first recorded in the study dataset or, in the case of the secondary use of data, the date on which the data extraction starts; and
- “end of data collection” means the date on which the analytical dataset is completely available.
29 Obligations as to post-authorisation safety studies¶
30 Format of the study protocol¶
The study protocol for a non-interventional post-authorisation safety studies must be submitted in the following format—31 Format of the abstract of the final study report¶
The abstract of the final study report for a non-interventional post-authorisation safety studies must be submitted in the following format—32 Format of the final study report¶
The final study report for a non-interventional post-authorisation safety studies must be submitted in the following format—SCHEDULE 13 ¶
Prescription only medicines for which community practitioner nurse prescribers are appropriate practitioners
Regulations 214(4) and 216(1)
- Co-danthramer Capsules NPF
- Co-danthramer Capsules Strong NPF
- Co-danthramer Oral Suspension NPF
- Co-danthramer Oral Suspension Strong NPF
- Co-danthrusate Capsules
- Co-danthrusate Oral Suspension NPF
- Mebendazole Tablets NPF
- Mebendazole Oral Suspension NPF
- Miconazole Oral Gel NPF
- Nystatin Oral Suspension
- Nystatin Pastilles NPF
- Streptokinase and Streptodornase Topical Powder NPF
- Water for injections
- In this Schedule “NPF” means the Nurse Prescribers' Formulary Appendix in the British National Formulary.
SCHEDULE 14 ¶
Prescription etc by supplementary prescribers: particulars of clinical management plan
Regulation 215
A clinical management plan must contain the following particulars—
SCHEDULE 15 ¶
Requirements for specific products subject to general sale
Regulation 221
| Column 1 | Column 2 |
|---|---|
Effervescent tablets— (a) that do not contain aspirin, or (b) that do not contain more than 325 milligrams of aspirin per tablet. | 30 tablets |
Effervescent tablets— (a) that contain more than 325 milligrams of aspirin per tablet, but (b) that do not contain more than 500 milligrams per tablet. | 20 tablets |
Non-effervescent tablets— (a) that are enteric-coated, (b) that contain aspirin only, and (c) that do not contain more than 75 milligrams per tablet. | 28 tablets |
| Other non-effervescent tablets | 16 tablets |
| Powder or granules | 10 sachets |
| Capsules | 16 capsules |
| Liquid preparations of paracetamol intended for persons aged 12 years and over | 160 millilitres |
| Liquid preparations of paracetamol intended for persons aged less than 12 years | Individual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses |
| Form of product | Maximum amount |
|---|---|
| Tablets | 16 tablets |
| Capsules | 16 capsules |
| Powder or granules | 12 sachets |
| Liquid preparations of ibuprofen | Individual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses |
SCHEDULE 16 ¶
Patient group directions and vaccine group directions
Regulations 229, 230, 231,232, 233 and 234
PART 1 Particulars to be included in a patient group direction and a vaccine group direction ¶
PART 2 Persons on whose behalf a patient group Direction must be signed¶
| Column 1: Class of person by whom product is supplied | Column 2: Person on whose behalf direction must be signed |
|---|---|
| Common Services Agency | The Agency |
| Health authority | The health authority |
| Special health authority | The special health authority |
| NHS trust or NHS foundation trust | The trust |
| Local authority | The Chief Executive or Director of Public Health of the local authority |
| the United Kingdom Health Security Agency | The Chief Executive of the United Kingdom Health Security Agency |
| Public Health Agency | The Public Health Agency |
| F2... | F2... |
A person who supplies medicinal products pursuant to an arrangement made with— | The Common Services Agency (where the arrangement has been made with the Agency); otherwise the— |
PART 3 Persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed¶
| Column 1: Force or service by whom or on whose behalf the health care is provided | Column 2: Person by whom or on whose behalf direction must be signed |
|---|---|
| A police force in England and Wales | The chief officer of police for that police force (within the meaning of the Police Act 1996 M83) |
| A police force in Scotland | The chief constable of that police force (within the meaning of the Police (Scotland) Act 1967 M84) |
| The Police Service of Northern Ireland | The Chief Constable of the Police Service of Northern Ireland |
| The prison service in England and Wales | The governor of the prison in relation to which the health care in question is being provided |
| The prison service in Scotland | The Scottish Prison Service Management Board |
| The prison service in Northern Ireland | The Northern Ireland Prison Service Management Board |
| Her Majesty's Forces | (a) the Surgeon General, (b) a Medical Director General, or (c) a chief executive of an executive agency of the Ministry of Defence |
| Contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency | Medical Director of the contractor carrying out search and rescue operations on behalf of the Maritime and Coastguard Agency |
PART 4 Classes of individuals by whom supplies may be made¶
- Pharmacists.
- Registered chiropodists and podiatrists.
- Registered dental hygienist.
- Registered dental therapist.
- Registered dietitians.
- Registered midwives.
- Registered nurses.
- Registered occupational therapists.
- Registered optometrists.
- Registered orthoptists.
- Registered orthotists and prosthetists.
- Registered paramedics.
- Registered pharmacy technicians.
- Registered physiotherapists.
- Registered radiographers.
- Registered speech and language therapists.
SCHEDULE 17 ¶
Exemption for sale, supply or administration by certain persons
Regulations 223(5)(b) and (c) 235,250(5) and 253(5)(d)
PART 1 Exemption from restrictions on sale and supply of prescription only medicines¶
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
| 1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research. | 1. All prescription only medicines. | 1. The sale or supply shall be— (a) subject to the presentation of an order signed by the principal of an institution concerned with educational research or the appropriate head of department in charge of a specified course of research stating— (i) the name of the institution for which the prescription only medicine is required, and (ii) the purpose for which the prescription only medicine is required, and (iii) the total quantity required; and (b) for the purpose of the education or research with which the institution is concerned. |
2. Persons selling or supplying prescription only medicines to any of the following— (b) an authorised officer within the meaning of section 5(6) of the Food Safety Act 1990 M87; (c) a sampling officer within the meaning of article 38(1) of the Food (Northern Ireland) Order 1989 M88; (d) an inspector acting under regulations 325 to 328; (e) a sampling officer within the meaning of Schedule 31. | 2. All prescription only medicines. | 2. The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in column 1 stating the status of the person signing it and the amount of prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions. |
| 3. Persons selling or supplying prescription only medicines to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of the drugs and appliances supplied under the National Health Service Act 2006 M89, the National Health Service (Scotland) Act 1978 M90, the National Health Service (Wales) Act 2006 M91 and the Health and Personal Social Services (Northern Ireland) Order 1972 M92, or under any subordinate legislation made under those Acts or that Order. | 3. All prescription only medicines | 3. The sale or supply shall be— (a) subject to the presentation of an order signed by or on behalf of the person so employed or engaged stating the status of the person signing it and the amount of the prescription only medicine required; and (b) for the purposes of a scheme referred to in column 1 in this paragraph. |
| 4. Registered midwives. | 4. Prescription only medicines containing any of the following substances— (a) Diclofenac; (b) Hydrocortisone Acetate; (c) Miconazole; (d) Nystatin; (e) Phytomenadione; | 4. The sale or supply shall be only in the course of their professional practice. |
| 5. Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968. | 5. Water for injection. | 5. The sale or supply is to a person— (a) for a purpose other than parenteral administration; or (b) who has been prescribed dry powder for parenteral administration but has not been prescribed the water for injection that is needed as a diluent. |
| 6. Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968. | 6. Items which are— (a) prescription only medicines which are not for parenteral administration and which— (i) are eye drops and are prescription only medicines by reason only that they contain not more than 0.5 per cent of Chloramphenicol, or (ii) are eye ointments and are prescription only medicines by reason only that they contain not more than 1.0 per cent Chloramphenicol, or (iii) are prescription only medicines by reason only that they contain any of the following substances— (aa) Cyclopentolate hydrochloride, (bb) Fusidic Acid, (cc) Tropicamide; (b) the following prescription only medicines— (i) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight, (ii) Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in lacquer does not exceed 5 per cent by weight in volume, (iii) Amoxicillin, (iv) Co-Codamol, (v) Co-dydramol 10/500 tablets, (vi) Codeine Phosphate, (vii) Erythromycin, (viii) Flucloxacillin, (ix) Silver Sulfadiazine, (x) Tioconazole 28%, (xi) Topical hydrocortisone where the maximum strength of hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight. | 6. The sale or supply shall be subject to the presentation of an order signed by— (a) a registered optometrist for a medicine listed under item (a) in column 2; (b) a registered chiropodist or podiatrist for a medicine listed under item (b) in column 2. |
| 7. Registered optometrists. | 7. Prescription only medicines listed in item (a) of paragraph 6 column 2. | 7. The sale or supply shall be only— (a) in the course of their professional practice, and (b) in an emergency. |
| 8. Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968. | 8. Medicinal products not for parenteral administration which are prescription only medicines by reason only that they contain any of the following substances— (a) Acetylcysteine, (b) Atropine sulphate, (c) Azelastine hydrochloride, (d) Diclofenac sodium, (e) Emedastine, (f) Homotropine hydrobromide, (g) Ketotifen, (h) Levocabastine, (i) Lodoxamide, (j) Nedocromil sodium, (k) Olopatadine, (l) Pilocarpine hydrochloride, (m) Pilocarpine nitrate, (n) Polymyxin B/bacitracin, (o) Polymyxin B/trimethoprim, (p) Sodium cromoglycate. | 8. The sale or supply shall be subject to the presentation of an order signed by an additional supply optometrist. |
| 9. Additional supply optometrists. | 9. Prescription only medicines specified in paragraph 8 column 2. | 9. The sale or supply shall be only— (a) in the course of their professional practice, and (b) in an emergency. |
| 10. Holders of UK marketing authorisations, F1135..., product licences or manufacturer's licences. | 10. Prescription only medicines referred to in those authorisations or licences. | 10. The sale or supply shall be only— (a) to a pharmacist, (b) so as to enable that pharmacist to prepare an entry relating to the prescription only medicine in question in a tablet or capsule identification guide or similar publication, and (c) of no greater quantity than is reasonably necessary for that purpose. |
| 11. Registered chiropodists or podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicine specified in column 2. | 11. The following prescription only medicines— (a) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight, (b) Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in lacquer does not exceed 5 per cent by weight in volume, (c) Amoxicillin, (d) Co-Codamol, (e) Co-dydramol 10/500 tablets, (f) Codeine Phosphate, (g) Erythromycin, (h) Flucloxacillin, (i) Silver Sulfadiazine, (j) Tioconazole 28%, (k) Topical hydrocortisone where the maximum strength of hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight. | 11. The sale or supply shall be only in the course of their professional practice. |
| 12. Persons selling or supplying prescription only medicines to a school. | 12. Prescription only medicines comprising:
| 12. The sale or supply shall be— (a) subject to the presentation of an order signed by the principal or head teacher at the school concerned stating— (i) the name of the school for which the medicinal product is required, (ii) the purpose for which that product is required, and (iii) the total quantity required, and (b) for the purpose of supplying or administering the medicinal product to pupils at the school in an emergency. |
| 13 Registered orthoptists against whose names are recorded in the relevant register annotations signifying that they are qualified to sell or supply the medicine specified in column 2. | 13 The following prescription only medicines– (a) Atropine, (b) Cyclopentolate, (c) Tropicamide, (d) Lidocaine with fluorescein, (e) Oxybuprocaine, (f) Proxymetacaine, (g) Tetracaine, (h) Chloramphenicol, (i) Fusidic acid. | 13 The sale or supply shall be only in the course of their professional practice. |
PART 2 Exemption from the restriction on supply of prescription only medicines¶
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
| 1. Royal National Lifeboat Institution and certified first aiders of the Institution. | 1. All prescription only medicines | 1. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the exercise of the functions of the Institution. |
| 2. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement. | 2. All prescription only medicines. | 2. The supply shall be only so far as is necessary for the treatment of persons on the ship. |
| 3. Persons authorised by licences granted under regulation 5 of the Misuse of Drugs Regulations 2001 M93 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002 M94 to supply a controlled drug. | 3. Such prescription only medicines, being controlled drugs, as are specified in the licence. | 3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence. |
| 4. Persons employed or engaged in the provision of lawful drug treatment services. | 4. Ampoules of sterile water for injection that contain no more than 2ml of water each. | 4. The supply shall be only in the course of provisions of lawful drug treatment services. |
| F1113. . . | F1113. . . | F1113. . . |
| 5. Persons requiring prescription only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees. | 5. Such prescription only medicines as may be specified in the relevant enactment. | 5. The supply shall be— (a) for the purpose of enabling them to comply with any requirements made by or in pursuance of any such enactment, and (b) subject to such conditions and such circumstances as may be specified in the relevant enactment. |
| 6. Persons operating an occupational health scheme. | 6. Prescription only medicines sold or supplied to a person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse. | 6. The supply of the prescription only medicine shall be— (a) in the course of operating an occupational health scheme, and (b) made by— (i) a doctor, or (ii) a registered nurse acting in accordance with the written directions of a doctor as to the circumstance in which such medicines are to be used in the course of an occupational health scheme. |
| 6a. Persons operating an occupational health scheme and occupational health vaccinators employed or engaged by them. | 6b. A prescription only medicine used for vaccination or immunisation F1587... sold or supplied to a person operating an occupational health scheme mentioned in entry 6a in response to an order in writing signed by a doctor or an occupational health vaccinator. | 6c. The supply of the medicine is in the course of an occupational health scheme mentioned in entry 6a and is made, if not by a doctor, by an occupational health vaccinator acting in accordance with the written directions of a doctor as to the circumstances in which such medicines are to be used. |
| 7. The operator or commander of an aircraft. | 7. Prescription only medicines which are not for parenteral administration and which have been sold or supplied to an operator or commander of an aircraft in response to an order in writing signed by a doctor. | 7. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft. |
| 8. Persons employed as qualified first-aid personnel on off-shore installations. | 8. All prescription only medicines. | 8. The supply shall be only so far as is necessary for the treatment of persons on the installation. |
| 9. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee. | 9. Prescription only medicines supplied to a person specified in column 1 in response to an order in writing signed by a doctor. | 9. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services. |
| 10. Persons (“P”) who are members of Her Majesty's armed forces. | 10. All prescription only medicines. | 10. The supply shall be— (a) in the course of P undertaking any function as a member of Her Majesty's armed forces; and (b) where P is satisfied that it is not practicable for another person who is legally entitled to supply a prescription only medicine to do so; and (c) only in so far as is necessary— (i) for the treatment of a sick or injured person in a medical emergency, or (ii) to prevent ill-health where there is a risk that a person would suffer ill-health if the prescription only medicine is not supplied. |
| 11. A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine. | 11. A prescription only medicinal product comprising an inhaler containing salbutamol. | 11. The supply shall be— (a) in the course of P carrying on the business of a school; (b) where supply is to a pupil at that school who is known to suffer from asthma; and (c) where the pupil requires the medicinal product in an emergency. |
| 12 Registered midwives. | 12 Prescription only medicines for parenteral administration that contain– (a) Diamorphine, (b) Morphine, (c) Pethidine hydrochloride. | 12 The supply shall be only in the course of their professional practice. |
| 13. Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2. |
13. The following prescription only medicines—
| 13. The supply shall be only in the course of their professional practice. |
PART 3 Exemptions from the restriction on administration of prescription only medicines¶
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
| 1. Registered chiropodists or podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2. | 1. Prescription only medicines for parenteral administration that contain— (a) Adrenaline, (b) Bupivacaine hydrochloride, (c) Bupivacaine hydrochloride with adrenaline where the maximum strength of adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride, (d) Levobupivacaine hydrochloride, (e) Lidocaine hydrochloride, (f) Lidocaine hydrochloride with adrenaline where the maximum strength of adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride, (g) Mepivacaine hydrochloride, (h) Methylprednisolone, (i) Prilocaine hydrochloride, (j) Ropivacaine hydrochloride. | 1. The administration shall only be in the course of their professional practice and where the medicine includes a combination of substances in column 2, those substances shall not have been combined by the chiropodist or podiatrist. |
| 2. Registered midwives and student midwives. | 2. Prescription only medicines for parenteral administration containing any of the following substances but no other substance that is classified as a product available on prescription only— (a) Adrenaline, (b) Anti-D immunoglobulin, (c) Carboprost, (d) Cyclizine lactate, (e) Diamorphine, (f) Ergometrine maleate, (g) Gelofusine, (h) Hartmann's solution, (i) Hepatitis B vaccine, (j) Hepatitis immunoglobulin, (k) Lidocaine hydrochloride, (l) Morphine, (m) Naloxone hydrochloride, (n) Oxytocins, natural and synthetic, (o) Pethidine hydrochloride, (p) Phytomenadione, (q) Prochloperazine, (r) Sodium chloride 0.9%. | 2. The medicine shall— (a) in the case of Lidocaine and Lidocaine hydrochloride, be administered only while attending on a woman in childbirth, and (b) where administration is— (i) by a registered midwife, be administered in the course of their professional practice; (ii) by a student midwife— (aa) be administered under the direct supervision of a registered midwife; and (bb) not include Diamorphine, Morphine or Pethidine hydrochloride. |
| 3. Persons who are authorised as members of a group by a group authority granted under regulations 8(3) or 9(3) of the Misuse of Drugs Regulations 2001 M95 or, regulations 8(3) or 9(3) of the Misuse of Drugs Regulations (Northern Ireland) 2002 M96, to supply a controlled drug by way of administration only. | 3. Prescription only medicines that are specified in the group authority. | 3. The administration shall be subject to such conditions and in such circumstances and to such extent as may be specified in the group authority. |
| 4. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement. | 4. All prescription only medicines that are for parenteral administration. | 4. The administration shall be only so far as is necessary for the treatment of persons on the ship. |
| 5. Persons operating an occupational health scheme. | 5. Prescription only medicines that are for parenteral administration sold or supplied to the person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse. | 5. The prescription only is administered in the course of an occupational health scheme, and the individual administering the medicine is— (a) a doctor, or (b) a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used. |
| 5a. Persons operating an occupational health scheme and occupational health vaccinators employed or engaged by them. | 5b. A prescription only medicine used for vaccination or immunisation F1589... sold or supplied to a person operating an occupational health scheme mentioned in entry 5a in response to an order in writing signed by a doctor or an occupational health vaccinator. | 5c. The administration of the medicine is in the course of an occupational health scheme mentioned in entry 5a, and the individual administering the medicine is, if not a doctor, an occupational health vaccinator acting in accordance with the written directions of a doctor as to the circumstances in which such medicines are to be used. |
| 6. The operator or commander of an aircraft. | 6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor. | 6. The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of the doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft. |
| 7. Persons employed as qualified first-aid personnel on off-shore installations. | 7. All prescription only medicines that are for parenteral administration. | 7. The administration shall be only so far as is necessary for the treatment of persons on the installation. |
| 8. Persons who are registered paramedics. | 8. The following prescription only medicines for parenteral administration— (a) Diazepam 5 mg per ml emulsion for injection, (b) Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion, (c) medicines containing the substance Ergometrine Maleate 500 mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient, (d) prescription only medicines containing one or more of the following substances, but no other active ingredient— (i) Adrenaline Acid Tartrate, (ii) Adrenaline hydrochloride, (iii) Amiodarone, (iv) Anhydrous glucose, (v) Benzlypenicillin, (vi) Compound Sodium Lactate Intravenous Infusion (Hartmann's Solution), (vii) Ergometrine Maleate, (viii) Furosemide, (ix) Glucose, (x) Heparin Sodium, (xi) Lidocaine Hydrochloride, (xii) Metoclopramide, (xiii) Morphine Sulphate, (xiv) Nalbuphine Hydrochloride, (xv) Naloxone Hydrochloride, (xvi) Ondansetron (xvii) Paracetamol, (xviii) Reteplase, (xix) Sodium Chloride, (xx) Streptokinase, (xxi) Tenecteplase. | 8. The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing. |
| 9. Persons who hold the advanced life support provider certificate issued by the Resuscitation Council (UK). | 9. The following prescription only medicines for parenteral administration — (a) Adrenaline 1:10,000 up to I mg; and (b) Amiodarone. | 9. The administration shall be only in an emergency involving cardiac arrest, and in the case of adrenaline the administration shall be intravenous only. |
| 10. Persons (“P”) who are members of Her Majesty’s armed forces. | 10. All prescription only medicines. | 10. The administration shall be—
|
| 11 A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine. | 11 A prescription only medicine comprising an auto-injector containing adrenaline. | 11 The administration shall be— (a) in the course of P carrying on the business of a school; (b) where administration is to a pupil at that school who is known to be at risk of anaphylaxis; and (c) where the pupil requires the medicinal product in an emergency. |
| 12. Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2. |
12. The following prescription only medicines for parenteral administration—
| 12. The administration shall be only in the course of their professional practice. |
PART 4 Exemptions from the restrictions in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products¶
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Persons exempted | Medicinal products to which exemption applies | Conditions |
| 1. Registered chiropodists and podiatrists. | 1. Medicinal products on a general sale list which are for external use and are not veterinary drugs and the following pharmacy medicines for external use— (a) Potassium permanganate crystals or solution; (b) ointment of heparinoid and hyaluronidase; and (c) products containing, as their only active ingredients, any of the following substances, at a strength, in the case of each substance, not exceeding that specified in relation to that substance— (i) 9.0 per cent Borotannic complex (ii) 10.0 per cent Buclosamide (iii) 3.0 per cent Chlorquinaldol (iv) 1.0 per cent Clotrimazole (v) 10.0 per cent Crotamiton (vi) 5.0 per cent Diamthazole hydrochloride (vii) 1.0 per cent Econazole nitrate (viii) 1.0 per cent Fenticlor (ix) 10.0 per cent Glutaraldehyde (x) 1.0 per cent Griseofulvin (xi) 0.4 per cent Hydrargaphen (xii) 2.0 per cent Mepyramine maleate (xiii) 2.0 per cent Miconazole nitrate (xiv) 2.0 per cent Phenoxypropan-2-ol (xv) 20.0 per cent Podophyllum resin (xvi) 10.0 per cent Polynoxylin (xvii) 70.0 per cent Pyrogallol (xviii) 70.0 per cent Salicylic acid (xix) 1.0 per cent Terbinafine (xx) 0.1 per cent Thiomersal. | |
| 2. Registered chiropodists and podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines in column 2. | 2. (a) The following prescription only medicines— (i) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight, (ii) Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in the lacquer does not exceed 5 per cent by weight in volume, (iii) Amoxicillin, (iv) Co-Codamol, (v) Co-dydramol 10/500 tablets, (vi) Codeine Phosphate, (vii) Erythromycin, (viii) Flucloxacillin, (ix) Silver Sulfadiazine, (x) Tioconazole 28%, (xi) Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight; and | 2. The sale or supply shall be only in the course of their professional practice, and the medicinal product must have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied. |
| (b) Ibuprofen, other than preparations of ibuprofen which are prescription only medicines. | ||
| 3. Registered optometrists. | 3. All medical products on a general sale list, all pharmacy medicines and prescription only medicines which are not for parenteral administration and which— (a) are eye drops and are prescription only medicines by reason only that they contain not more than— (i) 30.0 per cent Sulphacetamide Sodium, or (ii) 0.5 per cent Chloramphenicol, or (b) are eye ointments and are prescription only medicines by reason only that they contain not more than— (i) 30.0 per cent Sulphacetamide Sodium, or (ii) 1.0 per cent Chloramphenicol, or (c) are prescription only medicines by reason only that they contain any of the following substances— (i) Cyclopentolate hydrochloride, (ii) Fusidic acid, (iii) Tropicamide. | 3. The sale or supply shall be only— (a) in the case of medicinal products on a general sale list and pharmacy medicines, in the course of their professional practice; (b) in the case of prescription only medicines, in the course of their professional practice and in an emergency. |
| 4. Additional supply optometrists. | 4. Medicinal products which are prescription only medicines by reason only that they contain any of the following substances— (a) Acetylcysteine, (b) Atropine sulphate, (c) Azelastine hydrochloride, (d) Diclofenac sodium, (e) Emedastine, (f) Homotropine hydrobromide, (g) Ketotifen, (h) Levocabastine, (i) Lodoximide, (j) Nedocromil sodium, (k) Olopatadine, (l) Pilocarpine hydrochloride, (m) Pilocarpine nitrate, (n) Polymyxin B/bacitracin, (o) Polymyxin B/trimethoprim, (p) Sodium Cromoglycate. | 4. The sale or supply shall be only in the course of their professional practice and only in an emergency. |
| 5. Holders of manufacturer's licences where the licence in question contains a provision that the licence holder shall manufacture the medicinal product to which the licence relates only for a particular person after being requested by or on behalf of that person and in that person's presence to use his own judgement as to the treatment required. | 5. Medicinal products on a general sale list which are for external use and are not veterinary drugs and pharmacy medicines which are for external use in the treatment of hair and scalp conditions and which contain any of the following— (a) not more than 5.0 per cent of Boric acid, (b) Isopropyl myristate or Lauryl sulphate, (c) not more than 0.004 per cent Oestrogens, (d) not more than 1.0 per cent of Resorcinol, (e) not more than 3.0 per cent of Salicylic acid, (f) not more than 0.2 per cent of Sodium pyrithione. | 5. The licence holder shall sell or supply the medicinal product in question only to a particular person after being requested by or on behalf of that person and in that person's presence to use his own judgement as to the treatment required. |
| 6. Persons selling or supplying medicinal products to universities, other institutions concerned with higher education or institutions concerned with research. | 6. All medicinal products. | 6. The sale or supply shall be— (a) Subject to the presentation of an order signed by the principal of the institution concerned with education or research or the appropriate head of department in charge of the specified course of research stating— (i) the name of the institution for which the medicinal product is required, (ii) the purpose for which the medicinal product is required, and (iii) the total quantity required, and (b) for the purposes of the education or research with which the institution is concerned. |
| 7. Persons selling or supplying medicinal products to organisations for research purposes. | 7. All medicinal products. | 7. The sale or supply is only for the purposes of research and shall be— (a) subject to the presentation of an order signed by the representative of the organisation concerned stating— (i) who requires the medicine, (ii) the purposes for which it is required, (iii) the quantity required, and (iv) the purposes of the research with which the organisation is concerned; and (b) not for administration to humans. |
8. Persons selling or supplying medicinal products to any of the following— (a) a public analyst appointed under section 27 of the Food Safety Act 1990 or under article 27 of the Food Safety (Northern Ireland) Order 1991; (b) an agricultural analyst appointed under section 67 of the Agriculture Act 1970 M97, (c) a person duly authorised by an enforcement authority under regulations 325 to 328, (d) a sampling officer within the meaning a sampling officer within the meaning of Schedule 31. | 8. All medicinal products. | 8. The sale or supply is in connection with the exercise of any statutory function carried out by any person listed in sub-paragraphs (a) to (d) of column 1 provided that— (a) the medicinal products are requested on an order signed by or on behalf of a person listed in sub-paragraph (a) to (d) of column 1, and (b) the order gives— (i) the status of the person signing it, (ii) the amount of medicinal product required. |
| 9. Holders of a UK marketing authorisation, F1136..., a certificate of registration or a manufacturer's licence. | 9. Medicinal product referred to in the UK marketing authorisation, F1136..., certificate of registration or manufacturer's licence. | The sale or supply shall be only— (a) to a pharmacist, (b) so as to enable that pharmacist to prepare an entry relating to the medical product in question in a tablet or capsule identification guide or similar publication, and (c) of no greater quantity than is reasonably necessary for that purpose. |
| 10. Registered dispensing opticians. | 10. Pharmacy medicines for external use containing chloramphenicol at a strength not exceeding— (a) 0.5 per cent in eye drops; (b) 1 per cent in ointment. | 10. The sale or supply shall only be in the course of their professional practice. |
| 11. Operator or commander of an aircraft. | 11. All medicinal products on a general sale list. | 11. The medicinal product must—
|
| 12. The operator of a train. | 12. All medicinal products on a general sale list. | 12. The medicinal product must—
|
| 13 Registered orthoptists against whose names are recorded in the relevant register annotations signifying that they are qualified to sell or supply the medicine specified in column 2. | 13 All medicinal products on a general sale list, all pharmacy medicines and the following prescription only medicines– (a) Atropine, (b) Cyclopentolate, (c) Tropicamide, (d) Lidocaine with fluorescein, (e) Oxybuprocaine, (f) Proxymetacaine, (g) Tetracaine, (h) Chloramphenicol, (i) Fusidic acid. | 13 The sale or supply shall be only in the course of their professional practice. |
| 14. Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2. |
14. All medicinal products on a general sale list, all pharmacy medicines and the following prescription only medicines which are not for parenteral administration—
| 14. The sale, supply or offer for sale or supply shall be only in the course of their professional practice. |
PART 5 Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products¶
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| Persons exempted | Medicinal products to which exemption applies | Conditions |
| 1. Royal National Lifeboat Institution and certificated first aiders of the Institution. | 1. All medicinal products. | 1. The supply shall be only so far as is necessary for the treatment of sick or injured persons. |
| 2. British Red Cross Society and certificated first aid and certificated nursing members of the Society. | 2. All pharmacy medicines and all medicinal products on a general sale list. | 2. The supply shall be only so far as is necessary for the treatment of sick or injured persons. |
| 3. St John Ambulance Association and Brigade and certificated first aid and certificated nursing members of the Association and Brigade. | 3. All pharmacy medicines and all medicinal products on a general sale list. | 3. The supply shall be only so far as is necessary for the treatment of sick or injured persons. |
| 4. St. Andrew's Ambulance Association and certificated first aid and certificated nursing members of the Association. | 4. All pharmacy medicines and all medicinal products on a general sale list. | 4. The supply shall be only so far as is necessary for the treatment of sick and injured persons. |
| 5. Order of Malta Ambulance Corps and certificated first aid and certificated nursing members of the Corps. | 5. All pharmacy medicines and all medicinal products on a general sale list. | 5. The supply shall be only so far as is necessary for the treatment of sick or injured persons. |
| 6. Persons authorised by licences granted under regulation 5 of the Misuse of Drugs Regulations 2001 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002. | 6. Such prescription only medicines and such pharmacy medicines as are specified in the licence. | 6. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence. |
| 7. Persons employed or engaged in the provision of lawful drug treatment services. | 7. Ampoules of sterile water for injection that contain no more than 5ml of water each. | 7. The supply shall be only in the course of provision of lawful drug treatment services. |
| F1114. . . | F1114. . . | F1114. . . |
| 8. Persons requiring medicinal products for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees. | 8. Such prescription only medicines and such pharmacy medicines as may be specified in the relevant enactment and medicinal products on a general sale list. | 8. The supply shall be— (a) for the purpose of enabling compliance with any requirement made by or in pursuance of any such enactment, and (b) subject to such conditions and in such circumstances as may be specified in the relevant enactment. |
| 9. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement. | 9. All medicinal products. | 9. The supply shall be only so far as is necessary for the treatment of persons on the ship. |
| 10. Persons operating an occupational health scheme. | 10. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines as are sold or supplied to a person operating an occupational health scheme in response to an order signed by a doctor or a registered nurse. | 10. (a) The supply shall be in the course of an occupational health scheme. (b) The individual supplying the medicinal product, if not a doctor, shall be— (i) a registered nurse, and (ii) where the medicinal product in question is a prescription only medicine, acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of an occupational health scheme. |
| 10a. Persons operating an occupational health scheme and occupational health vaccinators employed or engaged by them. | 10b. A prescription only medicine used for vaccination or immunisation F1591... sold or supplied to a person operating an occupational health scheme mentioned in entry 10a in response to an order in writing signed by a doctor or an occupational health vaccinator. | 10c. The supply of the medicine is in the course of an occupational health scheme mentioned in entry 10a, and the individual supplying the medicine is, if not a doctor, an occupational health vaccinator acting in accordance with the written directions of a doctor as to the circumstances in which such medicines are to be used. |
| 11. Persons carrying on the business of a school providing full-time education. | 11. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride. | 11. The supply shall be— (a) in the course of a school dental scheme, and (b) if to a child under 16 only where the parent or guardian of that child has consented to such supply. |
| 12. Health authorities or Primary Health Trusts. | 12. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride. | 12. The supply shall be in the course of— (a) a pre-school dental scheme, and the individual supplying the medicinal product shall be a registered nurse, or (b) a school dental scheme, and if to a child under 16 only where the parent or guardian of that child has consented to such supply. |
| 13. The operator or commander of an aircraft. | 13. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of an aircraft in response to an order in writing signed by a doctor. | 13. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and, in the case of a prescription only medicine, shall be in accordance with the written instructions of a doctor as to the circumstances in which the prescription only medicines of the description in question are to be used on the aircraft. |
| 14. Persons employed as qualified first-aid personnel on offshore installations. | 14. All medicinal products. | 14. The supply shall be only so far as is necessary for the treatment of persons on the installation. |
| 15. A prison officer. | 15. All medicinal products on the general sale list. | 15. The supply shall only be so far as is necessary for the treatment of prisoners. |
| 16. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee. | 16. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are sold or supplied to a person specified in column 1 of this paragraph in response to an order in writing signed by a doctor. | 16. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services. |
| 17. Her Majesty's armed forces. | 17. All medicinal products. | 17. The supply shall be only so far as is necessary for the treatment of a sick or injured person or the prevention of ill-health. |
| 18. A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine. | 18. A prescription only medicinal product comprising an inhaler containing salbutamol. | 18. The supply shall be— (a) in the course of P carrying on the business of a school; (b) where supply is to a pupil at that school who is known to suffer from asthma; and (c) where the pupil requires the medicinal product in an emergency. |
| 19. Persons supplying medicinal products under an off-site emergency plan prepared under the Radiation (Emergency Preparedness and Public Information) Regulations 2019. | 19. Pharmacy medicines which contain any of the following substances but no other active ingredient— (a) Potassium Iodide; (b) Potassium Iodate. | 19. The supply shall be— (a) in accordance with the off-site emergency plan; and (b) only in the event that a radiation emergency has occurred or an event has occurred which could reasonably be expected to lead to a radiation emergency. |
| 20. A person or body listed in Part 1 or 2 of Schedule 1 to the Civil Contingencies Act 2004. | 20. Pharmacy medicines which contain any of the following substances but no other active ingredient— (a) Potassium Iodide; (b) Potassium Iodate. | 20. The supply shall only be in response to the occurrence, or likely occurrence, of one of the following events— (a) an emergency within the meaning of section 1 of the Civil Contingencies Act 2004; (b) a radiation emergency within the meaning of regulation 24 of the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009. |
SCHEDULE 18 ¶
Substances that may not be sold or supplied by a pharmacist without a prescription in reliance on regulation 225
Regulation 225
- Ammonium bromide
- Calcium bromide
- Calcium bromidolactobionate
- Embutramide
- Fencamfamin hydrochloride
- Fluanisone
- Hexobarbitone
- Hexobarbitone sodium
- Hydrobromic acid
- Meclofenoxate hydrochloride
- Methohexitone sodium
- Pemoline
- Piracetam
- Potassium bromide
- Prolintane hydrochloride
- Sodium bromide
- Strychnine hydrochloride
- Tacrine hydrochloride
- Thiopentone sodium
SCHEDULE 19 ¶
Medicinal products for parenteral administration in an emergency
Regulation 238
- Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis
- Atropine sulphate and obidoxime chloride injection
- Atropine sulphate and pralidoxime chloride injection
- Atropine sulphate injection
- Atropine sulphate, pralidoxime mesilate and avizafone injection
- Chlorphenamine injection
- Dicobalt edetate injection
- Glucagon injection
- Glucose injection
- Hydrocortisone injection
- Naloxone products
- Pralidoxime chloride injection
- Pralidoxime mesilate injection
- Promethazine hydrochloride injection
- Snake venom antiserum
- Sodium nitrite injection
- Sodium thiosulphate injection
- Sterile pralidoxime
SCHEDULE 20 ¶
Herbal medicinal products specified for the purposes of regulation 241
Regulation 241
PART 1 ¶
| Botanical Source | Common Name |
|---|---|
| Apocynum cannabinum | Canadian hemp |
| Areca catechu | Areca |
| Artemisia cina | Santonica |
| Brayera anthelmintica | Kousso |
| Catha edulis | Catha |
| Chenopodium ambrosioides var anthelminticum | Chenopodium |
| Crotalaria berberoana | Crotalaria fulva |
| Crotalaria spectabilis | Crotalaria spect. |
| Cucurbita maxima | Cucurbita |
| Delphinium staphisagria | Stavesacre seeds |
| Dryopteris filix-mas | Male fern |
Duboisia leichardtii Duboisia myoporoides | Duboisia |
| Ecballium elaterium | Elaterium |
Embelia ribes Embelia robusta | Embelia |
| Erysimum canescens | Erysimum |
| Holarrhena antidysenterica | Holarrhena |
| Juniperus sabina | Savin |
| Mallotus philippinensis | Kamala |
| Pausinystalia yohimbe | Yohimbe bark |
| Punica granatum | Pomegranate bark |
| Rhus radicans | Poison ivy |
Scopolia carniolica Scopolia japonica | Scopolia |
Strophanthus courmonti Strophanthus emini Strophanthus gratus Strophanthus hispidus Strophanthus kombe Strophanthus nicholsoni Strophanthus sarmentosus | Strophanthus |
Ulmus fulva Ulmus rubra | Slippery elm bark (whole or unpowdered) |
| Viscum album | Misletoe berry |
PART 2 ¶
| Column 1 | Column 2 | Column 3 | |
|---|---|---|---|
| Substance | |||
| Botanical Source | Common Name | Maximum dose and maximum daily dose | Percentage |
Aconitum balfourni Aconitum chasmanthum Aconitum deinorrhizum Aconitum lycoctonum Aconitum napellus Aconitum spicatum Aconitum stoerkianum Aconitum uncinatum var japonicum | Aconite | 1.3 per cent | |
| Adonis vernalis | Adonis vernalis | 100 mg (MD) 300mg (MDD) | |
| Aspidosperma quebrachoblanco | Quebracho | 50 mg (MD) 150 mg (MDD) | |
Atropa acuminata Atropa belladonna | Belladonna herb, belladonna root | In the form of belladonna herb: 50 mg (MD) 150 mg (MDD); In the form of belladonna root: 30 mg (MD) 90 mg (MDD) | |
| Chelidonium majus | Celandine | 2 g (MD) 6 g (MDD) | |
Cinchona calisaya Cinchona ledgerana Cinchona micrantha Cinchona officinalis Cinchona succirubra | Cinchona bark | 250 mg (MD) 750 mg (MDD) | |
| Colchicum autumnale | Colchicum corm | 100 mg (MD) 300 mg (MDD) | |
| Conium maculatum | Conium fruits, conium leaf | 7.0 per cent | |
| Convallaria majalis | Convallaria | 150 mg (MD) 450 mg (MDD) | |
Datura innoxia Datura stramonium | Stramonium | 50 mg (MD) 150 mg (MDD) | |
Ephedra distachya Ephedra equisetina Ephedra gerardiana Ephedra intermedia Ephedra sinica | Ephedra | 600 mg (MD) 1800 mg (MDD) | |
| Gelsemium sempervirens | Gelsemium | 25 mg (MD) 75 mg (MDD) | |
Hyoscyamus albus Hyoscyamus muticus Hyoscyamus niger | Hyoscyamus | 100mg (MD) 300 mg (MDD) | |
| Lobelia inflata | Lobelia | 200 mg (MD) 600 mg (MDD) | |
Pilocarpus jaborandi Pilocarpus microphyllus | Jaborandi | 5.0 per cent | |
| Rhus toxicodendron | Poison oak | 10.0 per cent | |
| Senecio jacobaea | Ragwort | 10.0 per cent | |
SCHEDULE 21 ¶
Medicinal products at high dilutions
Regulation 242
PART 1 Dilutions of unit preparations diluted to at least one part in a thousand (3x)¶
- Agaricus muscarius
- Ailanthus glandulosa
- Apocynum cannabinum
- Aurum lodatum
- Belladonna
- Bismuth Subgallate
- Bryonia alba dioica
- Calcium Fluoride
- Cantharis
- Cerium oxalicum
- Chelidonium majus
- Chenopodium oil
- Cina
- Colocynthis
- Convallaria majalis
- Gelsemium sempervirens
- Hyoscyamus niger
- Lycopodium
- Manganese acetate
- Ranunculus bulbosus
- Terebinthinae oleum
PART 2 Dilutions of unit preparations diluted to at least one part in a million (6x)¶
- Adonis vernalis
- Agaricus bulbosus
- Agaricus muscarius
- Agnus castus
- Ailanthus glandulosa
- Alum
- Amethyst
- Ammonium Iodide
- Amygdalae amarae
- Apatite
- Apocynum androsaemifolium
- Apocynum cannabinum
- Argentite
- Argentum Chloride
- Argentum Iodide
- Arnica
- Artemisia cina
- Aspidium filix-mas
- Aspidium anthelmintica
- Aurum Sulphide
- Balsamum copivae
- Balsamum peruvianum
- Barium Citrate
- Barium Citrate
- Barium Sulphate
- Bismuth Metal
- Bismuth Subgallate
- Bismuth Subnitrate
- Boletus laricis
- Bovista
- Cade Oil
- Calcium Fluoride
- Cantharis
- Carduus marianus
- Cedar Wood Oil
- Cerium Oxalicum
- Chalcocite
- Chalcopyrite
- Chelidonium majus
- Chenopodium Oil
- Colocynthis
- Convallaria majalis
- Copper Silicate, Nat.
- Crotalus horridus
- Cucurbita
- Cucumis melo
- Datura Stramonium
- Derris
- Diamond
- Ephedra vulgaris
- Ferric Acetate
- Ferrous Iodide
- Ferrous Oxalate
- Ferrous Sulphide
- Formic Acid
- Gall
- Gelsemium sempervirens
- Gneiss
- Granatum ( Pomegranate) Bark
- Harmamelis Virginiana
- Hepar Sulfuris
- Hyoscyamus niger
- Iris florentine
- Jaborandi
- Juniperus sabina
- Kalinite
- Lachmanthus tinctoria
- Lapis Albus
- Lycopodium
- Magnesium
- Magnesium Acetate
- Magnesium Chloride
- Magnetite
- Manganese Acetate
- Nicotiana tabacum
- Nicotiana tabacum oil
- Oleander
- Opuntia vulgaris
- Oxalic Acid
- Petroleum
- Phellandrium aquaticum
- Pix Liquida
- Platinum
- Platinum Chloride
- Potassium Hydroxide
- Potassium Silicate
- Pyrethrum
- Pyrolusite
- Ranunculus acris
- Ranunculus bulbosus
- Ranunculus flammula
- Ranunculus repens
- Ranunculus sceleratus
- Rhodium Oxynitrate
- Rhododendron chrysanthemum
- Rhus toxicodendron
- Salicylic Acid
- Scrophularia aquatica
- Sodium Aluminium Chloride
- Sodium Auro-chloride
- Sodium Hypochlorite
- Sodium Nitrate
- Squill
- Stannum Metal
- Staphisagria
- Sulphur Iodide
- Tamus communis
- Tannic Acid
- Terebinthinae Oleum
- Theridion
- Thuja occidentalis
- Topaz
- Uric Acid
- Zinc Hypophosphite
- Zinc Isovalerate
PART 3 Dilutions of unit preparations diluted to at least one part in ten (1x)¶
- Abies excelsa
- Abies nigra
- Abies nobilis
- Acalpha indica
- Agate
- Alisma plantago Aq.
- Alstonia scholaris
- Aluminium
- Amber (Succinum)
- Ambra grisea
- Ammonium Phosphate
- Angostura vera
- Anthoxanthum
- Apis mellifera
- Aqua Marina
- Aqua Mellis
- Aralia racemosa
- Aranea diadema
- Arum maculatum
- Arum triphyllum
- Asarum
- Asperula odorata
- Astacus fluviatillis
- Auric Chloride
- Badiaga
- Beech (fagus sylvestris)
- Bellis perennis
- Berberis aquifolium
- Borago officinalis
- Butyric Acid
- Calcium Metal
- Calcium Chloride
- Calcium Oxide
- Calcium Sulphate
- Castoreum
- Ceanothus americanus
- Cedron
- Cerato (Ceratostigma Willmottiana)
- Cherry Plum (Prunus cerasifera)
- Chestnut, Red and Sweet
- Cholesterinum
- Chrysolite
- Cistus canadensis
- Clematis erecta
- Conchae vera
- Conchiolinum
- Corallium Rubrum
- Crab Apple
- Crocus sativus
- Erbium
- Erigeron Canadense
- Fuligo
- Genista tinctoria
- Geum urbanum
- Glycogen
- Gnaphalium leontopodium
- Gold
- Gorse (Ulex europaeus)
- Graphites
- Gratiola officinalis
- Gymnocladus (American Coffee Tree)
- Haematoxylon Campechianum
- Hecla Lava (Ash from Mount Hecla)
- Hedeoma pulegioides
- Hedra helix
- Heliotrope
- Heracleum spondylium
- Herniaria
- Hornbeam (Carpinus betulus)
- Iberis amara
- Impatiens
- Iris germanica
- Iris pseudacorus
- Jacaranda procera
- Jatropha curcas
- Juncus communis
- Justica adhatoda
- Lamium album
- Laurus nobilis oil
- Laurocerasus
- Ledum palustre
- Lilium tigrinum
- Lonicera caprifolium
- Lysimachia vulgaris
- Magnesium Phosphate
- Magnesite
- Magnolia
- Marum verum
- Melilotus officinalis
- Menispermum canadense
- Pephitis putorius
- Mercurialis perennis
- Mimulus (Mimullis guttatus)
- Moschus
- Myrica gale
- Myrtus communis
- Ocimum basilicum
- Olive
- Oxalis acetosella
- Pangamic Acid
- Paullinia cupana
- Penthorum sedoides
- Pollen (mixed)
- Polygonatum multiflorum
- Polygonum aviculare
- Polypodium vulgare
- Primula vulgaris
- Prunella vulgaris
- Ptellea trifoliata
- Ratanhia
- Robinia pseudoacacia
- Rubia tinctorum
- Rumex acetosella
- Sal Marina
- Sarcolactic Acid
- Sarracenia purpurea
- Scleranthus (Scleranthus annuus)
- Silica
- Silphium laciniathum
- Sodium Benzoate
- Spongia marina
- Star of Bethlehem (Ornithogalum umbellatum)
- Ulmus campestris
- Vine
- Walnut (juglerus regia)
- Water Violet (Hottonia palustris)
- Wild Oat
- Wild Rose
PART 4 Dilutions of unit preparations diluted to at least one part in ten (1x) for external use¶
- Adonis vernalis
- Agricus bulbosus
- Agricus muscarius
- Agnus castus
- Allanthus glandulosa
- Alum
- Amethyst
- Ammonium Iodide
- Amygdalae amarae
- Apatite
- Apocynum androsaemifolium
- Apocynum cannabinum
- Argentite
- Argentum Chloride
- Argentum Iodide
- Artemisia cina
- Aspidium filix-mas
- Aspidium anthelmintica
- Aurum Sulphide
- Balsamum copaivae
- Balsamum peruvianum
- Barium Citrate
- Barium Sulphate
- Bismuth Metal
- Bismuth Subgallate
- Bismuth Subnitrate
- Boletus laricis
- Bovista
- Cade Oil
- Calcium Fluoride
- Carduus marianus
- Cedar Wood Oil
- Cerium Oxalicum
- Chalcocite
- Chalcopyrite
- Chelidonium majus
- Chenopodium Oil
- Colocynthis
- Convallaria majalis
- Copper Silicate, Nat
- Crotalus horridus
- Cucurbita
- Cucumis melo
- Datura stramonium
- Derris
- Diamond
- Ephedra vulgaris
- Ferric Acetate
- Ferrous Iodide
- Ferrous Oxalate
- Ferrous Sulphide
- Formic Acid
- Gall
- Gelsemium sempervirens
- Gneiss
- Hamamelis virginiana
- Hepar Sulfuris
- Hyoscyamus niger
- Iris florentine
- Jaborandi
- Juniperus sabina
- Kaolinite
- Lachmanthus tinctoria
- Lapis Albus
- Lycopodium
- Magnesium
- Magnesium Acetate
- Magnesium Chloride
- Magnetite
- Manganese Acetate
- Nicotiana tabacum
- Nicotiana tabacum oil
- Oleander
- Opuntia vulgaris
- Oxalic Acid
- Petroleum
- Phellandrium aquaticum
- Pix Liquida
- Platinum
- Platinum Chloride
- Potassium Hydroxide
- Potassium Silicate
- Pyrethrum
- Pyrolusite
- Ranunculus acris
- Ranunculus bulbosus
- Ranunculus flammula
- Ranunculus repens
- Ranunculus scelerantus
- Rhodium Oxynitrate
- Rhododendron chrysanthemum
- Rhus toxicidendron
- Salicylic Acid
- Scrophularia aquatica
- Sodium Aluminium Chloride
- Sodium Auro-chloride
- Sodium Hypochlorite
- Sodium Nitrate
- Squill
- Stannum Metal
- Sulphur Iodide
- Tannic Acid
- Terebinthinae Oleum
- Topaz
- Uric Acid
- Zinc Hypophosphite
- Zinc Isovalerate
SCHEDULE 22 ¶
Classes of person for the purposes of regulation 249
Regulation 249
Doctors
Dentists
Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.
Authorities or persons carrying on the business of—
Holders of wholesale dealer's licences or persons to whom the restrictions imposed by regulation 18(1) do not apply by virtue of an exemption in these Regulations.
Ministers of the Crown and Government departments.
Scottish Ministers.
Welsh Ministers.
A Northern Ireland Minister.
An NHS trust.
An NHS foundation trust.
A local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006).
The United Kingdom Health Security Agency .
Public Health Agency.
The Common Services Agency.
A health authority or a special health authority.
F8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A person other than an excepted person who carries on a business consisting (wholly or partly) of supplying medicinal products in circumstances corresponding to retail sale, or of administering such products, pursuant to an arrangement made with—
A person other than an excepted person who carries on a business consisting (wholly or partly) of the supply or administration of medicinal products for the purpose of assisting the provision of health care by or on behalf of, or under arrangements made by—
In this Schedule “excepted person” means—
SCHEDULE 23 ¶
Particulars in pharmacy records
Regulation 253
SCHEDULE 24 ¶
Packaging information requirements
Regulation 257
PART 1 Outer and immediate packaging¶
PART 2 Immediate packaging: blister packs¶
PART 3 Immediate packaging: small packages¶
PART 4 Outer and immediate packaging: advanced therapy medicinal products F1138...¶
34 ¶
The name of the advanced therapy medicinal product which is the international non-proprietary name, or if none, the common name.35 ¶
Where appropriate, whether the product is intended for babies, children or adults.36 ¶
The expiry date in clear terms including the year and month and, if applicable, day.37 ¶
A description of the active substance, expressed qualitatively and quantitatively.38 ¶
Where the product contains tissues and cells of human or animal origin—39 ¶
The pharmaceutical form and the contents by weight, volume or number of doses of the product.40 ¶
A list of excipients, including preservative systems.41 ¶
The method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated.42 ¶
A special warning that the product is to be stored out of the sight and reach and children.43 ¶
Any special warning necessary for the particular product.44 ¶
Any special storage precautions.45 ¶
Specific precautions relating to the disposal of the unused product or of waste derived from the product and, where appropriate, reference to any appropriate collection system.46 ¶
The name and address of the holder of the UK marketing authorisation and, where applicable, the name of the representative appointed by the holder to represent him.47 ¶
The UK marketing authorisation number.48 ¶
The manufacturer's batch number.49 ¶
The unique donation code assigned by a tissue establishment pursuant to—50 ¶
Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.PART 5 Immediate packaging: blister packs and small packaging (advanced therapy medicinal products F1139...)¶
51 ¶
The information specified in Part 2.52 ¶
The unique donation code assigned by a tissue establishment pursuant to—53 ¶
Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.PART 6 Outer and Immediate Packaging: POC Medicinal Products for sale or supply in Great Britain only¶
PART 7 Immediate Packaging: Blister Packs and Small Packaging (POC Medicinal Products for sale or supply in Great Britain only)¶
SCHEDULE 25 ¶
Packaging requirements: specific provisions
Regulation 258
PART 1 Medicines on prescription¶
PART 2 Transport, delivery and storage¶
PART 3 Pharmacy and prescription only medicines¶
PART 4 Medicines containing paracetamol¶
SCHEDULE 26 ¶
Packaging requirements: special provisions
Regulations 3(13) and 4(5)
PART 1 Supply by doctors, dentists, nurses, midwives and pharmacists ¶
PART 2 Pharmacy exceptions¶
SCHEDULE 27 ¶
Package leaflets
Regulation 260
PART 1 General requirements¶
PART 2 Paracetamol¶
Part 3 Advanced therapy medicinal products F1140...¶
18 ¶
The name of the advanced therapy medicinal product.19 ¶
Where appropriate, whether the product is intended for babies, children or adults.20 ¶
The common name of the advanced therapy medicinal product.21 ¶
The therapeutic group, or type of activity, of the product, in terms easily comprehensible for the patient.22 ¶
Where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.23 ¶
Where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin.24 ¶
The product's therapeutic indications.25 ¶
A list of information which is necessary before the medicinal product is taken or used, including—26 ¶
The list mentioned in paragraph 25 must—27 ¶
Instructions for proper use of the product including in particular—28 ¶
A description of the adverse reactions which may occur in normal use of the medicinal product and, if necessary, the action to be taken in such a case.29 ¶
A reference to the expiry date printed on the packaging of the product with—30 ¶
The date on which the package leaflet was last revised.SCHEDULE 28 ¶
Labelling requirements for registrable homoeopathic medicinal products
Regulation 264
PART 1 Outer and immediate packaging¶
PART 2 Blister packs etc contained in outer packaging¶
PART 3 Small immediate packaging¶
SCHEDULE 29 ¶
Labelling of traditional herbal medicinal products
Regulation 265
PART 1 Traditional herbal medicinal products: general¶
PART 2 Traditional herbal medicinal products not subject to general sale¶
SCHEDULE 30 ¶
Particulars for advertisements to persons qualified to prescribe or supply
Regulations 294, 295 and 297
C9SCHEDULE 31 ¶
Sampling
Regulation 328(3)
Introductory¶
Division of sample¶
Notice to person named on container¶
Analysis or other examination¶
Provisions as to evidence¶
Analysis under direction of court¶
Proof by written statement¶
Payment for sample taken under compulsory powers¶
SCHEDULE 32 ¶
Transitional provisions and savings
Regulation 347
Continuity of the law¶
Product licences¶
Product licences of right¶
Classification of UK marketing authorisation and certificate of registration¶
Advanced therapy medicinal products¶
Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)¶
Section 60 of the Medicines Act 1968 etc¶
SCHEDULE 33 ¶
Transitional arrangements: pharmacovigilance
Regulation 212
F10231 Pharmacovigilance system master file¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 Post-authorisation safety studies¶
Regulations 198, 199, 200, 201 and 202 (provisions relating to post authorisation safety studies) do not apply to post authorisation safety studies commenced before 21st July 2012.F3965 Reporting obligations¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F3969 Periodic safety update reports¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SCHEDULE 33A ¶
Transitional provision in relation to EU Exit
Regulation 347A
PART 1 Interpretation¶
- “the COMP” means the Committee for Orphan Medicinal Products of the EMA, established under Article 4 of the Orphan Regulation;
- “converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2);
- “the Paediatric Regulation” means Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, as it has effect in EU law;
- “the Paediatric Committee” means the committee of the EMA established under Article 3 of the Paediatric Regulation;
- “the Pharmacovigilance Risk Assessment Committee” means the Committee of the EMA established by Article 56(1)(aa) of Regulation (EC) No 726/2004; and
- “Regulation (EC) No 507/2006” means Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council, as it has effect in EU law.
PART 2 Manufacturing, wholesale dealing and brokering¶
2 Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion day¶
3 Approved country for import list on IP completion day (regulation 18A)¶
4 Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)¶
5 List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9))¶
PART 3 Transitional provision in respect of conversion of EU marketing authorisations in force immediately before IP completion day¶
6 Conversion of EU marketing authorisations in force before IP completion day¶
7 Classification of converted EU marketing authorisations¶
For the purposes of regulation 62 (classification of UK marketing authorisation), it is a term of a converted EU marketing authorisation that the product to which the authorisation relates is to be available—8 Obligations of licensing authority in connection with converted EU marketing authorisations¶
9 Obligations of holders of converted EU marketing authorisations¶
10 Powers of licensing authority in connection with provision of information¶
11 Variations of converted EU marketing authorisations notified or applied for before IP completion day¶
12 Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date¶
13 Variations of converted EU marketing authorisations sought in advance of the data submission date¶
14 Applications for renewals of converted EU marketing authorisations made before IP completion day¶
15 Applications for renewals of conditional marketing authorisations made before IP completion day¶
16 Applications for renewals of converted EU marketing authorisations made after IP completion day¶
17 Applications for renewals of conditional marketing authorisations made after IP completion day¶
18 Renewals of converted EU marketing authorisations sought in advance of the data submission date¶
19 Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations¶
20 Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission date¶
21 Article 61(3) notifications sought in advance of the data submission date¶
22 Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day¶
- “the specified period” means 4 weeks beginning with IP completion day; and
- “the transitional period” means the period of 24 months beginning with IP completion day.
23 Temporary exemption as to packaging requirements for converted EU marketing authorisations¶
24 Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day¶
25 Enforcement¶
If a holder of a converted EU marketing authorisation fails to comply with an obligation imposed on the holder by or under this Part, the licensing authority may suspend the authorisation until the holder complies with the obligation.PART 4 Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices¶
26ZA Status of certain UK marketing authorisations granted before IP completion day¶
26 Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day¶
27 Temporary exemption as to packaging requirements: change of place of establishment¶
27A Status of parallel import licences granted before IP completion day¶
28 Conversion of parallel distribution notices in to parallel import licences¶
29 Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A)¶
F148129A Application of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B)¶
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30 Existing data and marketing exclusivity and global marketing authorisations¶
31 Applications for EU marketing authorisations made before IP completion day¶
32 Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)¶
33 Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day¶
34 Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied¶
35 Transitional provision in respect of Plasma Master Files¶
36 Suspensions of UK marketing authorisations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive or Regulation (EC) No 726/2004¶
Where, immediately before IP completion day, a marketing authorisation, which is a UK marketing authorisation on IP completion day, has been suspended pursuant to the procedures in Chapter IV of Title III of 2001 Directive or Regulation (EC) No 726/2004, the suspension—37 Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion day¶
- “concluded before IP completion day”, in relation to an Article 31 referral, means—
- a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; or
- an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 31 referral procedure, has been given before IP completion day; and
- “specified matter” means—
- a matter referred under Article 31 of the 2001 Directive before IP completion day that concerns a proposal to suspend, revoke or otherwise vary a UK marketing authorisation or an EU marketing authorisation; but
- does not include a referral made under Article 107i of the 2001 Directive.
PART 5 Transitional provision in relation to variations of marketing authorisations other than converted EU marketing authorisations¶
38 Application or notification made before IP completion day in respect of a variation under Chapter IIa of Regulation (EC) No 1234/2008 (variations to purely national marketing authorisations)¶
39 Application or notification made before IP completion day in respect of a variation under Chapter II of Regulation (EC) No 1234/2008 (variations to marketing authorisations granted in accordance with Chapter 4 of the 2001 Directive)¶
40 Application or notification in respect of a variations made before IP completion day under Article 20 of Regulation (EC) No 1234/2008 (work-sharing procedure)¶
PART 6 Transitional provision in relation to the Paediatric Regulation¶
41 Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric Regulation¶
41A Transitional provision in relation to global marketing authorisations under the 2001 Directive¶
Where a relevant medicinal product is subject to a global marketing authorisation as described in Article 6 of the 2001 Directive before IP completion day, a paediatric investigation plan does not need to be carried out in relation to that product.PART 8 Transitional provision in respect of homoeopathic medicinal products¶
43 List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion day¶
44 Place of establishment for holders of certificates of registration established in EEA before IP completion day¶
45 Temporary exemption as to packaging requirements: change of place of establishment¶
46 Applications made for a certificate of registration for a registrable homoeopathic product before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied¶
47 Suspensions of certificates of registration that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive¶
Where, immediately before IP completion day, a certificate of registration has been suspended pursuant to the procedures in Chapter IV of Title III of 2001 Directive, the suspension—48 Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a certificate of registration that have not concluded before IP completion day¶
- “concluded before IP completion day”, in relation to an Article 31 referral, means—
- a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; or
- an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 31 referral procedure, has been given before IP completion day;
- “specified matter” means—
- a matter referred under Article 31 of the 2001 Directive before IP completion day that concerns a proposal to suspend, revoke or otherwise vary a certificate of registration; but
- does not include a referral made under Article 107i of the 2001 Directive.
PART 9 Transitional provision in respect of traditional herbal registrations¶
49 Place of establishment for holders of traditional herbal registrations established in EEA before IP completion day¶
50 Temporary exemption as to packaging requirements: change of place of establishment¶
51 List of approved countries for traditional use of a herbal medicinal product on IP completion day¶
52 Applications made for a traditional herbal registration before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied¶
53 Suspensions of traditional herbal registrations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive¶
Where, immediately before IP completion day, a traditional herbal registration in force in Great Britain only has been suspended pursuant to the procedures in Chapter IV of Title III of 2001 Directive, the suspension—54 Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a traditional herbal registration that have not concluded before IP completion day¶
- “concluded before IP completion day”, in relation to an Article 31 referral, means—
- a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; or
- an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 31 referral procedure, has been given before IP completion day; and
- “specified matter” means—
- a matter referred under Article 31 of the 2001 Directive before IP completion day that concerns a proposal to suspend, revoke or otherwise vary a traditional herbal registration; but
- does not include a referral made under Article 107i of the 2001 Directive.
55 Proposals to refer an application for a traditional herbal registration to the Committee for Herbal Medicinal Products and the procedure in Part 3 of Schedule 11 that were on-going at IP completion day¶
PART 10 Transitional provision in respect of pharmacovigilance¶
58 Referrals made under Article 107i of the 2001 Directive concerning the evaluation of data from pharmacovigilance activities which are not concluded before IP completion day¶
- “concluded before IP completion day”, in relation to an Article 107i referral, means—
- a Commission decision as provided for in Article 107k of the 2001 Directive has been taken before IP completion day; or
- an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 107i referral procedure in accordance with Article 107k(2), has been given before IP completion day;
- “specified matter” means a referral made under Article 107i of the 2001 Directive on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities.
59 Matters on-going at IP completion day in respect of periodic safety update reports¶
60 Matters on-going at IP completion day in relation to draft study protocols under Article 107n and 107o of the 2001 Directive (submission of, and amendment to, draft study protocols for required studies)¶
61 Matters on-going at IP completion day in respect of the follow up of final study reports¶
PART 11 Transitional provision in respect of Part 12¶
62 Approved country health professional list on IP completion day (regulation 214(6A))¶
PART 12 General provision in relation to transitional provisions¶
63 Licensing authority power to require information¶
SCHEDULE 33B ¶
Transitional Provision in relation to the Windsor Framework
Reg 347B
1 Existing marketing authorisations¶
2 Existing applications for marketing authorisation¶
3 Post-authorisation processes¶
SCHEDULE 34 ¶
Amendments to existing law
Regulation 348
PART 1 The Medicines Acts 1968 and 1971¶
.
.
.
.
.
.
; and
;
Medicines Act 1971¶
PART 2 Other primary legislation¶
Trade Descriptions Act 1968¶
House of Commons Disqualification Act 1975¶
.
Northern Ireland Assembly Disqualification Act 1975¶
.
Consumer Protection Act 1987¶
Environmental Protection Act 1990¶
Value Added Tax Act 1994¶
, and
Health Act 1999¶
Communications Act 2003¶
.
Christmas Day and New Year's Day Trading (Scotland) Act 2007¶
.
PART 3 Northern Ireland Orders in Council¶
Health and Personal Social Services (Northern Ireland) Order 1972¶
Pharmacy (Northern Ireland) Order 1976¶
Poisons (Northern Ireland) Order 1976¶
Diseases of Animals (Northern Ireland) Order 1981¶
Waste and Contaminated Land (Northern Ireland) Order 1997¶
Shops (Sunday Trading &c.) (Northern Ireland) Order 1997¶
PART 4 The Medicines for Human Use (Clinical Trials) Regulations 2004¶
;
;
;
; and
; and
.
; and
; and
PART 5 Other United Kingdom, Scotland and Wales Secondary legislation¶
Medicines (Administration of Radioactive Substances) Regulations 1978¶
Importation of Animal Products and Poultry Products Order 1980¶
Medicines Act (Hearings by Persons Appointed) (Scotland) Rules 1986¶
Medicines Act (Hearings by Persons Appointed) Rules 1986¶
Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989¶
.
.
;
.
.
Medical Devices (Consultation Requirements) (Fees) Regulations 1995¶
Prescription Only Medicines (Human Use) Order 1997¶
;
General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999¶
National Health Service (Charges for Drugs and Appliances) Regulations 2000¶
Biocidal Products Regulations 2001¶
.
Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001¶
Misuse of Drugs Regulations 2001¶
Medicines for Human Use (Kava-kava) (Prohibition Order) 2002¶
Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003¶
Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003¶
Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003¶
Health Professions (Parts of and Entries in the Register) Order of Council 2003¶
; and
Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003¶
.
;
;
;
; and
, and
.
National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004¶
National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004¶
National Health Service (General Medical Services Contracts) Regulations 2004¶
National Health Service (General Medical Services Contracts) (Wales) Regulations 2004¶
National Health Service (Personal Medical Services Agreements) Regulations 2004¶
National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004¶
Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004¶
.
General Optical Council (Registration Rules) Order of Council 2005¶
National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007¶
Human Tissue (Quality and Safety for Human Application) Regulations 2007¶
.
Legislative and Regulatory Reform (Regulatory Functions) Order 2007¶
,
,
,
,
, and
; and
.
, and
; and
.
; and
.
; and
.
; and
.
Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008¶
Specified Animal Pathogens Order 2008¶
Specified Animal Pathogens (Wales) Order 2008¶
Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008¶
Specified Animal Pathogens (Scotland) Order 2009¶
National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009¶
Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009¶
; and
.
; and
.
; and
.
Single Use Carrier Bags Charge (Wales) Regulations 2010¶
PART 6 Northern Ireland statutory rules¶
Control of Pesticides Regulations (Northern Ireland) 1987¶
.
Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995¶
Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996¶
Pharmaceutical Services Regulations (Northern Ireland) 1997¶
Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998¶
Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998¶
Importation of Animal Pathogens Order (Northern Ireland) 1999¶
Biocidal Products Regulations (Northern Ireland) 2001¶
.
Misuse of Drugs Regulations (Northern Ireland) 2002¶
.
Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003¶
Waste Management Licensing Regulations (Northern Ireland) 2003¶
Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004¶
Nursing Homes Regulations (Northern Ireland) 2005¶
Residential Care Homes Regulations (Northern Ireland) 2005¶
Children's Homes Regulations (Northern Ireland) 2005¶
Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006¶
Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007¶
Day Care Setting Regulations (Northern Ireland) 2007¶
Residential Family Centres Regulations (Northern Ireland) 2007¶
Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007¶
Specified Animal Pathogens Order (Northern Ireland) 2008¶
Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009¶
Private Water Supplies Regulations (Northern Ireland) 2009¶
SCHEDULE 35 ¶
Repeals and revocations
Regulation 349
| Enactment or instrument | Extent of repeal or revocation |
|---|---|
| Medicines Act 1968 (c. 67) | Sections 2A to 9. Section 10(7). Sections 11 to 14. Section 15(1) and (2). Sections 16 to 57. Section 58(1A), (2) and (3). Sections 59 to 61. Sections 65 and 66. Section 67(3A), (5) and (6). Section 68. Sections 85 and 86. Section 89. Section 91(1). Sections 92 to 103. Section 108(3) to (5) and (7). Section 109(3). Section 110(3). Section 111(3). Section 112(7). Sections 115 and 116. Section 126(4). Section 130(2) to (8) and (10). Section 132(2), (3) and (5). Schedules 1A and 2. In Schedule 3, paragraphs 5 to 7. |
| Medicines (Extension to Antimicrobial Substances) Order 1973 (S.I. 1973/367) | The whole Order. |
| Medicines (Specified Articles and Substances) Order 1976 (S.I. 1976/968) | The whole Order. |
| Medicines (Fluted Bottles) Regulations 1978 (S.I. 1978/40) | The whole of the Regulations. |
| Medicines (Medicines Act 1968 Amendment) Regulations 1983 (S.I. 1983/1724) | The whole of the Regulations. |
| Medicines (Products Other than Veterinary Drugs) (General Sale List) Amendment Order 1990 (S.I. 1990/1129) | The whole Order. |
| Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992 (S.I. 1992/605) | The whole of the Regulations. |
| Medicines Act 1968 (Amendment) Regulations 1993 (S.I. 1993/834) | The whole of the Regulations. |
| Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (S.I. 1994/105) | The whole of the Regulations. |
| Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1994 (S.I. 1994/899) | The whole of the Regulations. |
| Medicines (Advertising) Regulations 1994 (S.I. 1994/1932) | The whole of the Regulations. |
| Medicines (Monitoring of Advertising) Regulations 1994 (S.I. 1994/1933) | The whole of the Regulations. |
| Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144) | The whole of the Regulations. |
| Medicines Act 1968 (Amendment) Regulations 1995 (S.I. 1995/2321) | The whole of the Regulations. |
| Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996 (S.I. 1996/482) | The whole of the Regulations. |
| Prescription Only Medicines (Human Use) Order 1997 (S.I. 1997/1830) | The whole of the Order except articles 1(1) to (5), 5 and 10 and Schedules 1 and 2. |
| Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 1998 (S.I. 1998/3105) | The whole of the Regulations. |
| Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 (S.I. 1999/267) | The whole of the Regulations. |
| Medicines (Monitoring of Advertising) Amendment Regulations 1999 (S.I. 1999/784) | The whole of the Regulations. |
| Medicines (Codification Amendments Etc.) Regulations 2002 (S.I. 2002/236) | The whole of the Regulations |
| Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003 (S.I. 2003/1618) | The whole of the Regulations. |
| Medicines (Child Safety) Regulations 2003 (S.I. 2003/2317) | The whole of the Regulations. |
| Medicines (Advertising) Amendment Regulations 2004 (S.I. 2004/1480) | The whole of the Regulations. |
| Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765) | The whole Order. |
| Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/768) | The whole of the Regulations. |
| Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094) | The whole of the Regulations except paragraph 12(1), (4) and (5) of Schedule 1, and regulation 8 as it relates to those paragraphs. |
| Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005 (S.I. 2005/1520) | The whole of the Regulations. |
| Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/1710) | The whole of the Regulations. |
| Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750) | The whole of the Regulations except paragraph 8(a)(i) and (b) of Schedule 7, and regulation 12 as it relates to those paragraphs. |
| Medicines (Advisory Bodies) (No 2) Regulations 2005 (S.I. 2005/2754) | The whole of the Regulations, except Schedule 3, and regulation 4 as it relates to that Schedule, and paragraphs 3 and 7(1) and (3) of Schedule 4, and regulation 5 as it relates to those paragraphs. |
| Medicines (Advertising Amendments) Regulations 2005 (S.I. 2005/2787) | The whole of the Regulations. |
| Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789) | The whole of the Regulations. |
| Medicines (Traditional Herbal Medicinal Products for Human Use) (Consequential Amendment) Regulations 2006 (S.I. 2006/395) | The whole of the Regulations. |
| Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006 (S.I. 2006/1952) | The whole of the Regulations. |
| Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008 (S.I. 2008/1692) | The whole of the Regulations. |
| Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 (S.I. 2008/3097) | The whole of the Regulations. |
| Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 (S.I. 2009/1164) | The whole of the Regulations, except regulation 3. |
| Medicines (Exemptions and Miscellaneous Amendments) Order 2009 (S.I. 2009/3062) | The whole Order. |
| Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882) | The whole of the Regulations. |
Footnotes
- M11972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative Reform Act 2006 (2006 c,51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (2008 c.7). Section 2(5) was amended by section 41(1) of and Part 1 of Schedule 6 to the Northern Ireland Constitution Act 1973 (1973 c.36).
- M2S.I. 1972/1811.
- M3S.I. 1999/2027.
- M41968 c.67.
- M5Section 10(1) was amended by paragraph 10(a) of Part 1 of Schedule 8 to S.I. 2006/2407, paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001, and article 3 of S.I. 1971/1445. Section 10(2) was repealed by paragraph 10(b) and (3)(b) was repealed by paragraph 10(c) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(4) was amended and section 10(5) and (6) inserted by article 3 of S.I. 1971/1445. Section 10(6A) was repealed by paragraph 10(d) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(7) was inserted by article 3 of S.I. 1971/1445, and amended by regulation 3 of S.I. 1993/834. Section 10(7A) to (7C) was inserted by the Health Act 2006 section 26(1), and section 10(7A) was amended by paragraph 10(e) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(8) was inserted by S.I. 1971/1445 article 3. Section 10(9) was inserted by paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001.
- M62006 c.41.
- M7S.I. 1972/1265 (N.I. 14).
- M82009 c.1 (N.I.).
- M92006 c.42.
- M101978 c.29.
- M11OJ No L 121, 1.5.2001, p.34. Directive 2001/20/EC was last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14).
- M12S.I. 2004/1031, to which there are amendments not relevant to these Regulations.
- M131984 c.24. Section 14 was substituted by the Dentists Act 1984 (Amendment) Order 2005 (S.I. 2005/2011) articles 2 and 6 and further amended by the European Qualifications (Health and Social Care Professions) Regulations 2007 (S.I. 2007/3101), regulations 109 and 111. Other amendments of the Dentists Act are not relevant to these Regulations.
- M142003 c.21.
- M15S.I. 2002/254, as amended by S.I. 2009/1182. There are other amendments that are not relevant.
- M16S.I. 2010/231.
- M171993 c.21. Section 41 was amended by S.I. 2007/3101 regulations 206 and 214.
- M181994 c.17.
- M191984 c.24. Section 36B was inserted by S.I. 2005/2011, articles 2(1) and 29.
- M20S.I. 2006/1440, Schedule.
- M212006 c.41.
- M222006 c.42.
- M231978 c.29. Concurrent functions under section 36(1) were transferred to the National Waiting Times Board by article 4(2)(c) and (4) of S.S.I. 2002/305.
- M24S.I. 1972/1265 (N.I. 14), as amended by S.I. 1984/1158 (N.I. 8), S.I. 1986/595 ( N.I. 4) and 2004/311 (N.I. 2).
- M251997 c.46.
- M26S.I. 1997/1177 (N.I. 7).
- M27OJ No L 378, 27.12.2006, p.1. Regulation (EC) No 1901/2006, as amended by Regulation (EC) No 1902/2006 (OJ No L 378, 27.12.2006, p.20) .
- M28S.I. 2010/231.
- M29S.I. 1976/1213 (N.I. 22), as amended by S.R. 2008 No. 192.
- M30S.I. 2002/253, as amended by S.I. 2009/1182.
- M311989 c.44; section 7(a) was amended by S.I. 2005/848, articles 2 and 7(1).
- M321968 c.67. Sections 74A and 74J were inserted by article 68 of and paragraph 1 of Schedule 4 to S.I. 2010/231.
- M33Section 75 was amended by article 68 of and paragraph 1 of Schedule 4 to S.I. 2010/231
- M34OJ No L 334, 12.12.2008, p.7.
- M351978 c.29. Section 10(1) was amended by the Health Services Act 1980 (1980 c.53), Schedule 6 paragraph 2. There are other amendments not relevant to these Regulations.
- M361984 c.24. Section 36B was inserted by S.I. 2005/2011, articles 2(1) and 29.
- M372006 c.42.
- M381978 c.29. Section 2(1)(a) was amended by section 28(a)(i) of the National Health Service and Community Care Act 1990 (1990 c.19) and section 14(2) of, and paragraph 1 of Schedule 7 to, the Health and Social Services and Social Security Adjudications Act 1983 (1983 c.41).
- M39S.I. 1972/1265 (N.I. 14).
- M401983 c.20.
- M412000 c.14.
- M421978 c.29. Section 10F was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).
- M43S.I. 2003/431 (N.I. 9).
- M441978 c.29. Section 12A was inserted by section 31 of the National Health Service and Community Care Act 1990 (1990 c.19), and amended by section 46(1)(a) of the Health Act 1999 (1999 c.8).
- M45S.I. 1991/194 (N.I. 1), Health and Social Services trusts were renamed Health and Social Care trusts by section 1(3) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (2009 c.1 (N.I.)). There are other amendments not relevant to this regulation.
- M46References to a nursing home in these Regulations concern Northern Ireland only.
- M471952 c.52.
- M481989 c.45.
- M491953 c.18 (N.I.). Functions transferred by article 6(1) of, and Schedule 4 to, S.I. 2010/976.
- M501989 c.44; section 7 was amended by S.I. 2005/848, articles 2 and 7(1).
- M51Section 8B was inserted by S.I. 2007/3101, regulations 178 and 180.
- M522008 c.14.
- M531978 c.29. Section 10P was inserted by section 108 of the Public Services Reform (Scotland) Act 2010 (2010 asp 8).
- M54Section 2(1)(b) was inserted by section 28(a) of the National Health Service and Community Care Act 1990 (1990 c.19).
- M55S.I. 1990/247 (N.I. 3). Special Health and Social Services Agencies were renamed Special Health and Social Care Agencies by section 1(4) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (2009 c.1 (N.I.)).
- M561998 c.29.
- M571978 c.29.
- M582008 c.14.
- M59Regulated activities for the purposes of section 10 are defined in section 8 of that Act and set out in regulation 3 of, and Schedule 1 to, S.I. 2010/781.
- M602008 No. 1976 (W. 185).
- M61S.S.I. 2004/115
- M62S.R. (NI) 2004 No. 140.
- M63OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.
- M642003 c.21.
- M652003 c.21.
- M661990 c.42.
- M671996 c.55.
- M68Section 56(1) was amended by section 406(7) of and Schedule 19(1) to the Communications Act 2003.
- M691994 c.39. There is an amendment to section 2(1) that is not relevant to this regulation.
- M701972 c.9 (N.I.).
- M711990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.
- M721991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.
- M732000 c.36.
- M741995 c. 46.
- M751987 c.43. Section 2(4) was repealed in relation to England and Wales by S.I. 2000/2771 article 2(1) and (3) and in relation to Scotland by S.S.I. 2001/265 article 2(1) and (3).
- M76S.I. 1987/2049 (N.I. 20), as amended by 2001 c.13 (NI).
- M77S.I. 1997/1830, as amended by S.I. 1997/2044, S.I. 1998/108, S.I. 1998/1178, S.I. 1998/2081, S.I. 1999/1044, S.I. 1999/3463, S.I. 2000/1917, S.I. 2000/2899, S.I. 2000/3231, S.I. 2001/2777, S.I. 2001/3942, S.I. 2003/696 and S.I. 2006/915 and these Regulations. There are other amendments, but none is relevant.
- M78OJ No L 147, 9.6.1975, p.13, no longer in force.
- M79OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.
- M80OJ No L 31, 1.2.2002, p.1, as last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p. 14).
- M81OJ No L 334, 12.12.2008, p.7.
- M82OJ No L 15, 17.1.1987. p.38.
- M831996 c.16.
- M841967 c.77.
- M851990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.
- M861991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.
- M871990 c.16.
- M881989 No. 846 (N.I. 6).
- M892006 c. 41.
- M901978 c. 29.
- M912006 c. 42.
- M92S.I. 1972/1265 (N.I. 14).
- M93S.I. 2001/3998, to which there are amendments that are not relevant.
- M94S.R. 2002 No. 1, to which there are amendments that are not relevant.
- M95S.I. 2001/3998 as amended by S.I. 2007/2154. There are other amendments that are not relevant.
- M96S.R. 2002 No. 1, as amended by S.R. 2007 No. 348. There are other amendments that are not relevant.
- M971970 c.40: subsection (1) was amended by section 272(1) of and Schedule 30 to the Local Government Act 1972; section 16 of and Schedule 8 paragraph 15 to the Local Government Act 1985, and section 66(6) and (8) of, and Schedule 16 paragraph 38(5) and Schedule 18 to the Local Government (Wales) Act 1994. Subsection (1A) was inserted by section 66(6) of and Schedule 16 paragraph 38(5) to that Act. Subsection 2 was substituted by section 180(1) of and Schedule 13 paragraph 85(2) to the Local Government etc (Scotland) Act 1994, and subsection (7) was repealed by sections 1(1) and 194 of, and Schedule 1 paragraph 8 and Schedule 34 Part 1 to the Local Government, Planning and Land Act 1980.
- M981967 c.80.
- M99S.I. 1994/3144, as amended by S.I. 2004/3224 and S.I. 2005/2759. There are other amendments to those regulations that are not relevant to this paragraph..
- M100S.I. 1976/1726, as amended by S.I. 1977/996 and 2168, S.I. 1978/41 and 1140, S.I. 1981/1791, S.I. 1983/1729, S.I. 1985/1558 and 2008, S.I. 1988/1009, S.I. 1989/1183, S.I. 1992/3273, S.I. 1994/104 and 3144, S.I. 2002/236, S.I. 2004/1031 and S.I. 2005/2745 and 2753.
- M101S.I. 1977/1055, as amended by S.I. 1992/3274, 1994/104 and 3144, and 2005/2753..
- M102Section 28(3) was amended by Schedule 1 to the Animal Health and Welfare Act 1984 (1984 c.40), regulation 4(5) of S.I. 1977/1050, regulation 2(2) of S.I. 1975/1169, regulation 6(2) of S.I. 1994/276, regulation 2(a)(iii) of S.I. 2002/236 and paragraph 14 of Schedule 8 to S.I. 2006/2407.
- M103S.I. 1975/1326, as amended by S.I. 1979/1760 and S.I. 1994/1932.
- M104S.I. 1976/1726, as amended by S.I. 1977/996, S.I. 1977/2168, S.I. 1978/41, S.I. 1978/1140, S.I. 1981/1791, S.I. 1983/1729, S.I. 1985/1558, S.I. 1985/2008, S.I. 1988/1009, S.I. 1989/1183, S.I. 1992/3273, S.I. 1994/104 S.I. 1994/3144, S.I. 2002/236, S.I. 2004/1031, S.I. 2005/2745 and S.I. 2005/2753.
- M105S.I. 1977/1055, as amended by S.I. 1992/3274, S.I. 1994/104, S.I. 1994/3144, and S.I. 2005/2753.
- M106S.I. 1978/41, as amended by S.I. 2004/1771.
- M107S.I. 2010/1882.
- M108S.I. 1978/1006, as amended by S.I. 1995/2147, S.I. 2005/2754. S.I. 2006/2407 and S.I. 2006/2806.
- M1091968 c.67. Schedule 1A was inserted by regulation 7(2) of S.I. 2005/1094.
- M1101968, c.67. Section 10(1), 10(3) and 10(7A) were amended and 10(2) repealed by Part 1 paragraphs 1 and 10 of Schedule 8 to S.I. 2006/2407, section 10(1), 10(4) were amended and 10(5) to (7) and 10(8) inserted by article 3 of S.I. 1971/1445, section 10(1) was amended and section 10(9) inserted by paragraph 5 Schedule 1 to the Regulations of Care (Scotland) Act 2001, and section 10(7A) to (7C) were inserted by section 26(1) of the Health Act 2006.
- M111Section 15(3) was amended by paragraphs 1 and 11(b) of Part 1 of Schedule 8 to S.I. 2006/2407.
- M112Section 58((1), (4) and (6) was amended by paragraph 29 of Part 1 of Schedule 8 to S.I. 2006/2407. Section 58(4) was amended by paragraph 2(b) of Schedule 5 to S.I. 2002/53. Section 58(4) was amended by section 63(1 and (4) of, and section 58(4A) and (4C) inserted by section 63(1) and (5) of, the Health and Social Care Act 2001.
- M113Section 58A was inserted by regulation 2 of S.I. 1992/3271, and the heading substituted by and subsection (1) amended by paragraph 30 Part 1 of Schedule 8 to S.I. 2006/2407.
- M114Section 62(7) was substituted by paragraph 12(5) of Schedule 1 to S.I. 2005/1094.
- M115Section 67(1B) was inserted by section 63(7) of the Health and Social Care Act 2001, and section 67(3A) inserted and section 67(4) amended by paragraph 8 of Schedule 5 to S.I. 2005/2789
- M116Section 72(1)(c) was amended by paragraph 12(a) of Schedule 5 to the Adults with Incapacity (Scotland) Act 2000 and paragraph 14(a) of Schedule 6 to the Mental Capacity Act 2005, and section 72(4)(c) by paragraph 14(d) of Schedule 6 to the Mental Capacity Act 2005.
- M117S.I. 1986/594 (N.I. 4).
- M118Section 87(1) was amended by paragraph 44 of Part 1 of Schedule 8 to S.I. 2006/2407.
- M119Section 88(1) was amended by paragraph 45 of Part 1 of Schedule 8 to S.I. 2006/2407.
- M120Section 91(2) and (3) was amended by paragraph 48(b) and (c) of Part 1 of Schedule 8 to S.I. 2006/2407, and section 91(2) was amended by section 32(2) of the Magistrates' Courts Act 1980.
- M121Section 108(2) was amended and 108(12) inserted by paragraph 8 of Schedule 3 to the Food Safety Act 1990, section 108(6A) to (6D) was inserted and section 108(9) and (10) amended by section 31(1) of the Health Act 2006, section 108(9) was amended by paragraph 56(c), section 108(10) by paragraph 56(d) and section 108(11) by paragraph 56(e) of Part 1 of Schedule 8 to S.I. 2006/2407, and section . 108(12) was amended by paragraph 33 of Schedule 16 to the Local Government (Wales) Act 1994.
- M122Section 109(2)(c) was repealed by paragraph 9(a) of Schedule 3 to the Food Safety Act 1990, and section 109(2)(d) was repealed by paragraph 57 of Part 1 of Schedule 8 to S.I. 2006/2407.
- M123Section 110(1) was amended by paragraph 58(a) and section 110(5)(a) was amended by paragraph 58(c)(i) of Part 1 of Schedule 8 to S.I. 2006/2407, and section 110(3A) and (3B) were inserted by section 31(3)(b) and section 110(5)(a) amended by section 31(3)(c) of the Health Act 2006. In relation to Northern Ireland,
- M124The amendments in paragraph 19(b)(iii) and (iv), (f) and (g) reproduce amendments already made with effect in Northern Ireland by article 2 and the Schedule to S.R. (NI) 1973 No 211.
- M1251972 c. 9 (N.I.).
- M126Section 111(1)(aa) was inserted by paragraph 9 of Schedule 5 to S.I. 2005/2789.
- M127Section 121(4) was amended by paragraph 61 of Part 1 of Schedule 8 to S.I. 2006/2407.
- M128Section 122(2) was amended by paragraph 62 of Part 1 of Schedule 8 to S.I. 2006/2407.
- M129Section 125(4) was amended by paragraph 63 of Part 1 of Schedule 8 to S.I. 2006/2407.
- M130Section 126(3) was amended by paragraph 64(c) of Part 1 of Schedule 8 to S.I. 2006/2407.
- M131Section 129(2) was amended by paragraph 65(a) of and section 129(3) was amended by paragraph 65(b) of Part 1 of Schedule 8 to S.I. 2006/2407.
- M132Section 130(1) was amended by paragraph 66(a) of Part 1 of Schedule 8 to S.I. 2006/2407.
- M133Section 131(5) was amended by paragraphs 43 and 44 of Schedule 1 to the National Health Service (Consequential Provisions) Act 2006, paragraph 30 of Schedule 16 to the National Health Service (Scotland) Act 1978 and paragraph 128(2) of Schedule 4 to the National Health Service Reorganisation Act 1973.
- M134Paragraph 17 of Schedule 3 was amended by paragraph 66 of Part 1 of Schedule 8 to S.I. 2006/2407.
- M135Paragraphs 2 to 5, 7 and 9(b) and (c) and following words of Schedule 4 were omitted by paragraphs 69(a), (c) and (e)(iii) and (iv) of Part 1 of Schedule 8 to S.I. 2006/2407. Paragraph 6 was amended by paragraph 69(b), paragraph 8 by paragraph 69(d), paragraph 9 by paragraph 69(e) and paragraph 10 by paragraph 69(f) of that Part.
- M1361971 c.69.
- M1371968 c.29. Paragraph (b) of section 2(5) was inserted by paragraph 16 of Schedule 5 to the Medicines Act 1968.
- M1381975 c.24.
- M1391975 c.25.
- M1401987 c.43. Section 19(1) was amended by paragraph 7 of Part 1 of Schedule 9 to S.I. 2006/2407; there are other amendments to that subsection, but none is relevant.
- M1411990 c.43. Section 142(7) was amended by paragraph 8 of Schedule 4 to the Radioactive Substances Act 1993 (1993 c.12), in relation to England and Wales by paragraph 5(1) and (12) of Part 1 of Schedule 26 to S.I. 2010/675, and by paragraph 8 of Part 1 of Schedule 9 to S.I. 2006/2407.
- M1421994 c.23. In Part II of Schedule 8, note (2B) to Group 12 was inserted by S.I. 2009/2972, and note (11)(a) to Group 15 was amended by paragraph 10(a), and (11)(d) inserted by paragraph 10(b), of Schedule 9 to S.I. 2006/2407.
- M1431999 c.8. Subsection (2A) was inserted by paragraph 1 of Schedule 8 to the Health and Social Care Act 2008 (2008 c.14).
- M1442003 c.21. Section 368R was inserted by regulation 2 of S.I. 2009/2979.
- M1452007 asp 13.
- M146S.I. 1972/1265 (N.I. 14). Article 57D was inserted by article 4 of the Primary Medical Services (Northern Ireland) Order 2004 (S.I. 2004/311 (N.I. 2))
- M147S.I. 1976/1213 (N.I. 22).
- M148S.I. 1976/1214 (N.I. 23).
- M149S.I. 1981/1115 (N.I. 22).
- M150S.I. 1997/2778 (N.I. 19). Article 33(6) was amended by S.R. (NI) 2006 No 45.
- M151S.I. 1997/2779 (N.I. 20).
- M152S.I. 2004/1031, as amended by S.I. 2005/2754. There are other amendments, but none is relevant.
- M153S.I. 1978/1006, as amended by S.I. 1995/2147 and S.I. 2006/2407. There are other amendments, but none is relevant.
- M154S.I. 1980/14, as amended by S.I. 1994/2920, S.I. 1994/3142 and S.I. 1994/3144.
- M155S.I. 1986/1700. There are amendments, but none is relevant.
- M156S.I. 1986/1761, as amended by S.I. 2006/2407. There are other amendments, but none is relevant.
- M157S.I. 1989/684, as amended by S.I. 1995/871, S.I. 2004/1031 and S.I. 2005/2754. There are other amendments, but none is relevant.
- M158S.I. 1995/449
- M159S.I. 1997/1830, as amended by S.I. 1997/2044, S.I. 1998/108, S.I. 1998/1178, S.I. 1998/2081, S.I. 1999/1044, S.I. 1999/3463, S.I. 2000/1917, S.I. 2000/2899, S.I. 2000/3231, S.I. 2001/2777, S.I. 2001/3942, S.I. 2003/696, and S.I. 2006/915. There are other amendments, but none is relevant.
- M160S.I. 1999/3267, as amended by S.I. 2005/1476. There are other amendments, but none is relevant.
- M161S.I. 2000/620, as amended by S.I. 2000/3189 and S.I. 2009/1166. There are other amendments, but none is relevant.
- M162S.I. 2001/880, as amended by S.I. 2010/745. There are other amendments, but none is relevant.
- M163S.I. 2001/1841, as amended by S.I. 2005/2750 and S.I. 2008/548.
- M164S.I. 2001/3998, as amended by S.I. 2003/2429, S.I. 2005/271, S.I. 2006/986, S.I. 2006/1450, S.I. 2007/2154 and 2012/973. There are other amendments, but none is relevant.
- M165S.I. 2002/3170, as amended by S.I. 2005/2750 and S.I. 2008/548.
- M166S.I. 2003/1374. There are amendments, but none is relevant.
- M167S.I. 2003/1376. There are amendments, but none is relevant.
- M168S.I. 2003/1571, as amended by S.I. 2006/1996. There are other amendments, but none is relevant.
- M169S.I. 2003/1680, as amended by S.I. 2004/3224, S.I. 2005/2750 and S.I. 2005/2754.
- M170S.S.I. 2004/115, as amended by S.S.I. 2005/337. There are other amendments, but none is relevant.
- M171S.S.I. 2004/116, as amended by S.S.I. 2005/336. There are other amendments, but none is relevant.
- M172S.I. 2004/478, as amended by S.I. 2006/358 and S.I. 2010/1647. There are other amendments, but none is relevant.
- M173S.I. 2004/1022, as amended by S.I 2005/366 and S.I. 2009/1977. There are other amendments, but none is relevant.
- M174S.I. 2004/1975.
- M175S.I. 2005/1478, as amended by S.I. 2008/1940. There are other amendments, but none is relevant.
- M176S.I. 2007/121, as amended by S.I. 2009/1175 and S.I. 2010/1647. There are other amendments, but none is relevant.
- M177S.I. 2007/1523.
- M178S.I. 2007/3544, as amended by S.I. 2009/2981. There are other amendments, but none is relevant.
- M179S.I. 2008/548.
- M180S.I. 2008/944. There are amendments, but none is relevant.
- M181S.I. 2008/1270. There are amendments, but none is relevant.
- M182S.I. 2008/3258. There are amendments, but none is relevant.
- M183S.S.I. 2009/45. There are amendments, but none is relevant.
- M184S.S.I. 2009/183.
- M185S.I. 2009/669. There are amendments, but none is relevant.
- M186S.I. 2010/2880. There are amendments, but none is relevant.
- M187S.R. (NI) 1987 No 414, as amended by S.R. (NI) 1997 No 469.
- M188S.R. (NI) 1995 No 8, as amended by S.R. (NI) 2009 No 429. There are other amendments, but none is relevant.
- M189S.R. (NI) 1996 No 81.
- M190S.R. (NI) 1997 No 381, as amended by S.R. (NI) 1999 No 405. There are other amendments, but none is relevant.
- M191S.R. (NI) 1998 No 28.
- M192S.R. (NI) 1998 No 45, as amended by S.R. (NI) 2011 No 124.
- M193S.R. (NI) 1999 No 433.
- M194S.R. (NI) 2001 No 422.
- M195S.R. (NI) 2002 No 1, as amended by S.R. (NI) 2003 No 324, S.R. (NI) 2003 No 420, S.R. (NI) 2005 No 119, S.R. (NI) 2005 No 564, S.R. (NI) 2006 No 214, S.R. (NI) 2006 No 264, and S.R. (NI) 2007 No 348.
- M196S.R. (NI) 2003 No 34.
- M197S.R. (NI) 2003 No 493.
- M198S.R. (NI) 2004 No 140, as amended by S.R. (NI) 2005 No 368.
- M199S.R. (NI) 2005 No 160.
- M200S.R. (NI) 2005 No 161.
- M201S.R. (NI) 2005 No 176.
- M202S.R. (NI) 2006 No 478.
- M203S.R. (NI) 2007 No 68.
- M204S.R. (NI) 2007 No 234.
- M205S.R. (NI) 2007 No 236.
- M206S.R. (NI) 2007 No 420.
- M207S.R. (NI) 2008 No 336.
- M208S.R. (NI) 2009 No 225.
- M209S.R. (NI) 2009 No 413.
- C1Reg. 2 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
- C2Reg. 8(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
- C3Reg. 322 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
- C4Reg. 323(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
- C5Reg. 324(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
- C6Regs. 325-330 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
- C7Regs. 332-339 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
- C8Reg. 343 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
- C9Sch. 31 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))
- F1Words in Sch. 16 Pt. 2 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(a) (with Sch. 3 para. 28)
- F2Words in Sch. 16 Pt. 2 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(b) (with Sch. 3 para. 28)
- F3Words in Sch. 16 Pt. 2 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(c)(i) (with Sch. 3 para. 28)
- F4Words in Sch. 16 Pt. 2 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(c)(ii) (with Sch. 3 para. 28)
- F5Words in Sch. 16 Pt. 2 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(d)(i) (with Sch. 3 para. 28)
- F6Words in Sch. 16 Pt. 2 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(7)(d)(ii) (with Sch. 3 para. 28)
- F7Words in Sch. 22 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(8)(a) (with Sch. 3 para. 28)
- F8Words in Sch. 22 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(8)(b) (with Sch. 3 para. 28)
- F9Words in Sch. 22 inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(8)(c)(i) (with Sch. 3 para. 28)
- F10Words in Sch. 22 omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(8)(c)(ii) (with Sch. 3 para. 28)
- F11Words in reg. 213(1) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(b) (with Sch. 3 para. 28)
- F12Words in reg. 213(1) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(c) (with Sch. 3 para. 28)
- F13Words in reg. 213(1) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(d) (with Sch. 3 para. 28)
- F14Words in reg. 213(1) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(e)(ii) (with Sch. 3 para. 28)
- F15Words in reg. 213(1) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(2)(f) (with Sch. 3 para. 28)
- F16Words in reg. 229 heading inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(3)(a) (with Sch. 3 para. 28)
- F17Reg. 229(1)(da) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(3)(b) (with Sch. 3 para. 28)
- F18Reg. 229(1)(e) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(3)(c) (with Sch. 3 para. 28)
- F19Words in reg. 229(1)(f) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(3)(d)(i) (with Sch. 3 para. 28)
- F20Words in reg. 229(1)(f) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(3)(d)(ii) (with Sch. 3 para. 28)
- F21Words in reg. 230(6)(a) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(4) (with Sch. 3 para. 28)
- F22Reg. 233(1)(a)(iva)-(ivc) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(5)(a)(i) (with Sch. 3 para. 28)
- F23Reg. 233(1)(a)(v) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(5)(a)(ii) (with Sch. 3 para. 28)
- F24Words in reg. 247(3)(a) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(6)(a) (with Sch. 3 para. 28)
- F25Reg. 247(4) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(6)(b) (with Sch. 3 para. 28)
- C10Instrument modified (10.5.2013) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 (S.I. 2013/898), reg. 2(5)
- F26Pt. 12A inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(2), 28
- F27Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4
- F28Pt. 3 Ch. 2 heading inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4
- F29Reg. 18 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 5
- F30Pt. 3 Chs. 3, 4 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 16
- F31Reg. 37 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 11
- F32Reg. 44 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 15
- F33Reg. 210A inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 25
- F34Reg. 346 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 31
- F35Sch. 5 para. 1 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(a)
- F36Sch. 7A inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 33
- F37Sch. 8 para. 9A inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 34
- F38Reg. 327(4)(c)(d) substituted for reg. 327(4)(c) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 29(2)
- F39Reg. 327(2)-(4) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 29(3)
- F40Reg. 327(6) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 29(4)
- F41Words in reg. 8(1) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 3(a)(i)
- F42Words in reg. 8(1) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 3(a)(ii)
- F43Words in reg. 8(1) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 3(a)(iii)
- F44Words in reg. 8(1) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 3(a)(iv)
- F45Words in reg. 8(1) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 3(a)(v)
- F46Words in reg. 8(1) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 3(a)(vi)
- F47Words in reg. 8(1) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 3(a)(vii)
- F48Words in reg. 8(1) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 3(a)(viii)
- F49Reg. 8(8) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 3(b)
- F50Reg. 19(5) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 6
- F51Reg. 20(1)(ca)(cb) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 7(a)
- F52Word in reg. 20(1)(d)(iii) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 7(b)
- F53Reg. 20(1)(d)(iv)-(vi) substituted for reg. 20(1)(d)(iv) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 7(c)
- F54Reg. 27(5) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 8
- F55Reg. 32 revoked (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 35
- F56Words in reg. 34(1) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 9(a)
- F57Word in reg. 34(4)(5) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 9(b)
- F58Word in reg. 36(2) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 10
- F59Reg. 42(2) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 13
- F60Reg. 43(7)(c)(8) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 14(a)
- F61Reg. 43(10)-(15) substituted for reg. 43(10) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 14(b)
- F62Reg. 68(11A) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 17
- F63Reg. 110(8A) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 19
- F64Reg. 135(10A) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 20
- F65Words in reg. 177(5) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 21(3)
- F66Reg. 206(1) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 23(2)
- F67Reg. 206(4) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 23(3)
- F68Reg. 214(5A)(5B) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 26
- F69Reg. 223(3)(b)(vi)-(ix) substituted for reg. 223(3)(b)(vi)(vii) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 27
- F70Reg. 330(1)(2) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 30
- F71Word in Sch. 5 para. 3(11)(b)(iv) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(b)(i)
- F72Sch. 5 para. 3(11)(b)(vi)-(viii) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(b)(ii)
- F73Word in Sch. 5 para. 5(2)(d) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(c)(i)
- F74Sch. 5 para. 5(2)(e)-(h) substituted for Sch. 5 para. 5(2)(e) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(c)(ii)
- F75Sch. 17 Pt. 4 Table Item 11, 12 inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 9
- F76Words in reg. 8(1) substituted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 2(2)
- F77Words in reg. 8(1) substituted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 2(3)
- F78Reg. 73(5A)-(5C) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 3
- F79Reg. 113(3A) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 5
- F80Reg. 142(5A)-(5C) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 6
- F81Reg. 196(1)-(2C) substituted for reg. 196(1) (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(2)
- F82Words in reg. 196(3) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(3)
- F83Reg. 196(8) substituted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(7)
- F84Reg. 346(2)(b)(xiva) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 8
- F85Reg. 346(2)(b)(xxiva) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 8
- F86Reg. 346(2)(b)(xxviiia) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 8
- F87Reg. 217A inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 6 and reg. 217A inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 6
- F88Words in Sch. 17 Pt. 3 added (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 11 and words in Sch. 17 Pt. 3 added (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 11
- F89Words in reg. 165 inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 3 and words in reg. 165 inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 3
- F90Words in reg. 213(1) omitted (E.W.S.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(i) and words in reg. 213(1) omitted (N.I.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(i)
- F91Words in reg. 213(1) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(ii) and words in reg. 213(1) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(ii)
- F92Words in reg. 213(1) omitted (E.W.S.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(iv) and words in reg. 213(1) omitted (N.I.) (31.3.2014) by virtue of The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(iv)
- F93Words in reg. 213(1) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(a)(v) and words in reg. 213(1) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(a)(v)
- F94Reg. 213(3) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 4(b) and reg. 213(3) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 4(b)
- F95Words in reg. 214(5)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(5)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)
- F96Words in reg. 214(5A) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(5A) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)
- F97Words in reg. 214(5B) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(5B) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)
- F98Words in reg. 214(6) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(a) and words in reg. 214(6) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(a)
- F99Words in reg. 217(3)(b) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(b) and words in reg. 217(3)(b) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(b)
- F100Reg. 218(3) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 7(3) and reg. 218(3) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 7(3)
- F101Reg. 218(5) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 7(4) and reg. 218(5) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 7(4)
- F102Words in reg. 224(5) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(d) and words in reg. 224(5) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(d)
- F103Words in reg. 225(4)(b) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(e) and words in reg. 225(4)(b) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(e)
- F104Words in reg. 242(1)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(g) and words in reg. 242(1)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(g)
- F105Words in reg. 242(3)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(g) and words in reg. 242(3)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(g)
- F106Words in reg. 253(5)(b)(ii) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(h) and words in reg. 253(5)(b)(ii) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(h)
- F107Reg. 346(2)(c)(xxviiib)-(xxviiie) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 9(2)(a) and reg. 346(2)(c)(xxviiib)-(xxviiie) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 9(2)(a)
- F108Reg. 346(4) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 9(3) and reg. 346(4) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 9(3)
- F109Word in reg. 346(5)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 9(4) and word in reg. 346(5)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 9(4)
- F110Words in Sch. 1 para. 1(b) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 10 and words in Sch. 1 para. 1(b) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 10
- F111Words in reg. 49 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 49 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(a)
- F112Words in reg. 59 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 59 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(d)
- F113Words in reg. 62 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(f)
- F114Words in reg. 68 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 68 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(h)
- F115Reg. 57A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 7 and reg. 57A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 7
- F116Reg. 65A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 9 and reg. 65A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 9
- F117Reg. 66A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 10 and reg. 66A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 10
- F118Reg. 80A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 15 and reg. 80A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 15
- F119Reg. 95A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 16 and reg. 95A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 16
- F120Reg. 191A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 20 and reg. 191A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 20
- F121Sch. 8A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 26 and Sch. 8A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 26
- F122Words in Sch. 17 Pt. 1 added (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 27(2) and words in Sch. 17 Pt. 1 added (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 27(2)
- F123Words in Sch. 17 Pt. 2 added (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 27(3) and words in Sch. 17 Pt. 2 added (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 27(3)
- F124Words in Sch. 17 Pt. 5 added (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 27(4) and words in Sch. 17 Pt. 5 added (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 27(4)
- F125Reg. 49(1) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 5 and reg. 49(1) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 5
- F126Words in reg. 49(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 49(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(b)
- F127Reg. 50(1A) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 6(2) and reg. 50(1A) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 6(2)
- F128Words in reg. 50(5) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 6(4) and words in reg. 50(5) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 6(4)
- F129Words in reg. 50(6) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 6(5) and words in reg. 50(6) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 6(5)
- F130Words in reg. 50(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 50(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(c)
- F131Words in reg. 59(1) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(2) and words in reg. 59(1) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(2)
- F132Reg. 59(1A) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(3) and reg. 59(1A) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(3)
- F133Words in reg. 59(4) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(4) and words in reg. 59(4) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(4)
- F134Words in reg. 59(4) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 59(4) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(e)
- F135Words in reg. 59(6) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 59(6) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(e)
- F136Words in reg. 62(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(g)
- F137Words in reg. 62(3) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62(3) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(g)
- F138Words in reg. 62(5) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 62(5) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(g)
- F139Words in reg. 68(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 68(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(i)
- F140Reg. 68(4) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 11(2) and reg. 68(4) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 11(2)
- F141Reg. 68(5) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 11(3) and reg. 68(5) substituted (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 11(3)
- F142Words in reg. 69(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 69(1)(7) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(j)
- F143Words in reg. 69(7) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 69(1)(7) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(j)
- F144Words in reg. 71(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 13 and words in reg. 71(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 13
- F145Words in reg. 76(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 76(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(m)
- F146Words in reg. 77 inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 77 inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(n)
- F147Words in reg. 96(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 96(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(o)
- F148Reg. 97 substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 17 and reg. 97 substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 17
- F149Words in reg. 98(2)(a) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 98(2)(a) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(p)
- F150Words in reg. 75(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(2) and words in reg. 75(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(2)
- F151Reg. 75(2A) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(3) and reg. 75(2A) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(3)
- F152Words in reg. 75(3) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(4) and words in reg. 75(3) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(4)
- F153Reg. 75(4A) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(5) and reg. 75(4A) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(5)
- F154Words in reg. 75(5) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(6) and words in reg. 75(5) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(6)
- F155Words in reg. 75(6) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(7) and words in reg. 75(6) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(7)
- F156Words in reg. 75(8) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(8) and words in reg. 75(8) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(8)
- F157Words in reg. 75(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 75(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(l)
- F158Words in reg. 75(6) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 75(6) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(l)
- F159Words in reg. 75(8) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 75(8) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(l)
- F160Words in reg. 101(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 101(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(q)
- F161Reg. 172(2) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 18 and reg. 172(2) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 18
- F162Words in reg. 177(2) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 19 and words in reg. 177(2) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 19
- F163Reg. 195(1)(a)(b) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 21 and reg. 195(1)(a)(b) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 21
- F164Words in reg. 213(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 22(b) and words in reg. 213(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 22(b)
- F165Reg. 218(2) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 23 and reg. 218(2) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 23
- F166Reg. 294(2A)(2B) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 24(2) and reg. 294(2A)(2B) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 24(2)
- F167Word in Sch. 27 para. 13 omitted (E.W.S.) (1.10.2014) by virtue of The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 28(2) and word in Sch. 27 para. 13 omitted (N.I.) (1.10.2014) by virtue of The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 28(2)
- F168Sch. 27 para. 14 substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 28(3) and Sch. 27 para. 14 substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 28(3)
- F169Words in Sch. 30 para. 7 substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 29 and words in Sch. 30 para. 7 substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 29
- F170Words in Sch. 16 Pt. 2 added (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(a) and words in Sch. 16 Pt. 2 added (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(a)
- F171Word in Sch. 16 Pt. 2 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(b)(i) and word in Sch. 16 Pt. 2 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(b)(i)
- F172Words in Sch. 16 Pt. 2 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(b)(ii) and words in Sch. 16 Pt. 2 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(b)(ii)
- F173Word in Sch. 16 Pt. 2 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(c)(i) and word in Sch. 16 Pt. 2 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(c)(i)
- F174Words in Sch. 16 Pt. 2 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(c)(ii) and words in Sch. 16 Pt. 2 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(c)(ii)
- F175Words in Sch. 16 Pt. 3 added (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(3) and words in Sch. 16 Pt. 3 added (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(3)
- F176Words in Sch. 22 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 8(2) and words in Sch. 22 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 8(2)
- F177Words in Sch. 22 substituted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 8(3) and words in Sch. 22 substituted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 8(3)
- F178Word in Sch. 22 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 8(4) and word in Sch. 22 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 8(4)
- F179Words in Sch. 22 substituted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 8(5) and words in Sch. 22 substituted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 8(5)
- F180Words in reg. 213(1) inserted (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 3(2)(a) and words in reg. 213(1) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 3(2)(a)
- F181Words in reg. 213(1) inserted (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 3(2)(b) and words in reg. 213(1) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 3(2)(b)
- F182Word in reg. 229(1)(da) omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 4(2)(a) and word in reg. 229(1)(da) omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 4(2)(a)
- F183Word in reg. 229(1)(f) substituted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 4(2)(c) and word in reg. 229(1)(f) substituted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 4(2)(c)
- F184Reg. 234(2)(c)-(e) substituted for reg. 234(2)(c)(d) (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 5(2) and reg. 234(2)(c)-(e) substituted for reg. 234(2)(c)(d) (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 5(2)
- F185Reg. 346(2)(c)(xxviiif)(xxviiig) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 6(2)(a) and reg. 346(2)(c)(xxviiif)(xxviiig) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 6(2)(a)
- F186Reg. 346(2)(d)(ivza) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 6(2)(b)(i) and reg. 346(2)(d)(ivza) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 6(2)(b)(i)
- F187Reg. 346(2)(d)(ivb) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 6(2)(b)(iii) and reg. 346(2)(d)(ivb) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 6(2)(b)(iii)
- F188Sch. 34 para. 73(a) revoked (E.) (1.4.2015) by The National Health Service (Charges for Drugs and Appliances) Regulations 2015 (S.I. 2015/570), reg. 1, Sch. 3
- F189Reg. 219A inserted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 5 and reg. 219A inserted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 5
- F190Words in reg. 218(8) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 3 and words in reg. 218(8) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 3
- F191Words in reg. 219(1) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(2) and words in reg. 219(1) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(2)
- F192Reg. 219(3) omitted (E.W.S.) (1.7.2015) by virtue of The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(3) and reg. 219(3) omitted (N.I.) (1.7.2015) by virtue of The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(3)
- F193Words in reg. 219(4) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(4)(a) and words in reg. 219(4) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(4)(a)
- F194Reg. 219(4)(b)(c) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(4)(b) and reg. 219(4)(b)(c) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(4)(b)
- F195Reg. 219(5) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 4(5) and reg. 219(5) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 4(5)
- F196Words in reg. 246(a) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 6 and words in reg. 246(a) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 6
- F197Words in reg. 269(1) inserted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 7 and words in reg. 269(1) inserted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 7
- F198Reg. 346(2)(c)(xxviiie) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 8 and reg. 346(2)(c)(xxviiie) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 8
- C11Pt. 12 modified (E.W.) (1.10.2015) by The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 (S.I. 2015/895), regs. 1(3), 4(2)
- F199Words in Sch. 17 Pt. 2 added (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 10(2) and words in Sch. 17 Pt. 2 added (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 10(2)
- F200Words in Sch. 17 Pt. 5 added (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 10(3) and words in Sch. 17 Pt. 5 added (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 10(3)
- F201Words in reg. 8(2) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 3(2) and words in reg. 8(2) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 3(2)
- F202Word in reg. 8(4) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 3(4) and word in reg. 8(4) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 3(4)
- F203Words in reg. 38(3)(b) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 4 and words in reg. 38(3)(b) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 4
- F204Reg. 44(1) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(2) and reg. 44(1) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(2)
- F205Word in reg. 44(2) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(3)(a) and word in reg. 44(2) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(3)(a)
- F206Word in reg. 44(2) inserted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(3)(b) and word in reg. 44(2) inserted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(3)(b)
- F207Reg. 44(2)(d) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(3)(d) and reg. 44(2)(d) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(3)(d)
- F208Word in reg. 44(3) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(4) and word in reg. 44(3) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(4)
- F209Reg. 44(4) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(5) and reg. 44(4) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(5)
- F210Word in reg. 44(5) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(6) and word in reg. 44(5) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(6)
- F211Words in reg. 233(5)(a) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 7(3) and words in reg. 233(5)(a) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 7(3)
- F212Word in reg. 256E(a) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 8 and word in reg. 256E(a) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 8
- F213Reg. 346(2)(c)(xxviiifa) inserted (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 9(2)(a) and reg. 346(2)(c)(xxviiifa) inserted (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 9(2)(a)
- F214Sch. 34 para. 85 revoked (E.) (7.12.2015) by The National Health Service (General Medical Services Contracts) Regulations 2015 (S.I. 2015/1862), reg. 1(2), Sch. 5 (with reg. 2)
- F215Sch. 34 para. 87 revoked (E.) (7.12.2015) by The National Health Service (Personal Medical Services Agreements) Regulations 2015 (S.I. 2015/1879), reg. 1(2), Sch. 4 (with regs. 2, 88)
- F216Words in Sch. 17 Pt. 1 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(2) and words in Sch. 17 Pt. 1 inserted (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(2)
- F217Words in Sch. 17 Pt. 2 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(3) and words in Sch. 17 Pt. 2 inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(3)
- F218Words in Sch. 17 Pt. 4 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(4) and words in Sch. 17 Pt. 4 inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(4)
- F219Words in reg. 8(1) substituted (1.4.2016) by The Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190), regs. 1, 62
- F220Words in reg. 8(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(a) and words in reg. 8(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(a)
- F221Words in reg. 8(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(b) and words in reg. 8(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(b)
- F222Words in reg. 8(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(c) and words in reg. 8(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(c)
- F223Word in reg. 8(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(d)(i) and word in reg. 8(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(d)(i)
- F224Words in reg. 8(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 3(2)(d)(ii) and words in reg. 8(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 3(2)(d)(ii)
- F225Reg. 20(1)(cc) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 5(2)(a) and reg. 20(1)(cc) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 5(2)(a)
- F226Word in reg. 20(1)(d)(v) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 5(2)(b)(i) and word in reg. 20(1)(d)(v) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 5(2)(b)(i)
- F227Reg. 20(1)(d)(vii) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 5(2)(b)(ii) and reg. 20(1)(d)(vii) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 5(2)(b)(ii)
- F228Word in reg. 43(6)(b) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 6(2)(a) and word in reg. 43(6)(b) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 6(2)(a)
- F229Reg. 43(6)(d) and preceding word inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 6(2)(b) and reg. 43(6)(d) and preceding word inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 6(2)(b)
- F230Word in reg. 44(6) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 7 and word in reg. 44(6) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 7
- F231Words in reg. 213(1) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(a) and words in reg. 213(1) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(a)
- F232Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(b) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(b)
- F233Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(c) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(c)
- F234Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(d) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(d)
- F235Words in reg. 213(1) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(e) and words in reg. 213(1) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(e)
- F236Words in reg. 213(1) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 8(2)(f) and words in reg. 213(1) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 8(2)(f)
- F237Reg. 214(5C) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 9 and reg. 214(5C) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 9
- F238Word in reg. 223(3)(b)(viii) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 10(2)(a) and word in reg. 223(3)(b)(viii) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 10(2)(a)
- F239Reg. 223(3)(b)(x) and preceding word inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 10(2)(b) and reg. 223(3)(b)(x) and preceding word inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 10(2)(b)
- F240Words in reg. 229(2) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 11 and words in reg. 229(2) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 11
- F241Words in reg. 248(1)(a) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 12(2) and words in reg. 248(1)(a) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 12(2)
- F242Words in reg. 248(2)(a) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 12(3) and words in reg. 248(2)(a) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 12(3)
- F243Reg. 256A renumbered as reg. 256A(1) (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 13(a) and reg. 256A renumbered as 256A(1) (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 13(a)
- F244Reg. 256A(2) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 13(b) and reg. 256A(2) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 13(b)
- F245Words in reg. 256B(8)(b) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 14 and words in reg. 256B(8)(b) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 14
- F246Word in reg. 346(2)(c)(i) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(i) and word in reg. 346(2)(c)(i) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(i)
- F247Words in reg. 346(2)(c)(iv) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(ii) and words in reg. 346(2)(c)(iv) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(ii)
- F248Reg. 346(2)(c)(xxviiiba) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(iii) and reg. 346(2)(c)(xxviiiba) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(iii)
- F249Reg. 346(2)(c)(xxviiiea) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(iv) and reg. 346(2)(c)(xxviiiea) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(iv)
- F250Words in reg. 346(2)(c)(xxviiif) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(v) and words in reg. 346(2)(c)(xxviiif) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(v)
- F251Reg. 346(2)(c)(xxviiih) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(vi) and reg. 346(2)(c)(xxviiih) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(vi)
- F252Sch. 23 para. 1(a)(v)-(ix) substituted for Sch. 23 para. 1(a)(v)(vi) (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 17 and Sch. 23 para. 1(a)(v)-(ix) substituted for Sch. 23 para. 1(a)(v)(vi) (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 17
- F253Words in reg. 8(1) inserted (22.7.2016) by The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016 (S.I. 2016/696), reg. 1, Sch. 3 para. 8(1)
- F254Words in reg. 219(5) substituted (22.7.2016) by The Electronic Identification and Trust Services for Electronic Transactions Regulations 2016 (S.I. 2016/696), reg. 1, Sch. 3 para. 8(2)
- F255Words in Sch. 17 Pt. 1 substituted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(2)(a)(i) and words in Sch. 17 Pt. 1 substituted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(2)(a)(i)
- F256Words in Sch. 17 Pt. 1 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(2)(a)(ii) and words in Sch. 17 Pt. 1 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(2)(a)(ii)
- F257Words in Sch. 17 Pt. 1 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(2)(b) and words in Sch. 17 Pt. 1 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(2)(b)
- F258Words in Sch. 17 Pt. 3 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(3) and words in Sch. 17 Pt. 3 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(3)
- F259Words in Sch. 17 Pt. 4 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(4) and words in Sch. 17 Pt. 4 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(4)
- F260Words in reg. 8(1) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 3(2)(a) and words in reg. 8(1) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 3(2)(a)
- F261Words in reg. 8(1) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 3(2)(b)(i) and words in reg. 8(1) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 3(2)(b)(i)
- F262Word in reg. 8(1) omitted (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 3(2)(b)(ii) and word in reg. 8(1) omitted (N.I.) (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 3(2)(b)(ii)
- F263Words in reg. 8(1) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 3(2)(b)(iii) and words in reg. 8(1) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 3(2)(b)(iii)
- F264Word in reg. 45B(1) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 4 and word in reg. 45B(1) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 4
- F265Words in reg. 167(7)(b) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 5(2)(b) and words in reg. 167(7)(b) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 5(2)(b)
- F266Words in reg. 213(1) omitted (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 6 and words in reg. 213(1) omitted (N.I.) (1.10.2017) by virtue of The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 6
- F267Reg. 173(d) substituted (6.2.2018) by The Ionising Radiation (Medical Exposure) Regulations 2017 (S.I. 2017/1322), reg. 1, Sch. 4 para. 2(2) (as substituted (6.2.2018) by S.I. 2018/121, regs. 1(2), 2(4)(b)(i))
- F268Reg. 240 substituted (6.2.2018) by The Ionising Radiation (Medical Exposure) Regulations 2017 (S.I. 2017/1322), reg. 1, Sch. 4 para. 2(3) (as substituted (6.2.2018) by S.I. 2018/121, regs. 1(2), 2(4)(b)(ii))
- F269Words in Sch. 17 Pt. 5 inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 12(2) and words in Sch. 17 Pt. 5 inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 12(2)
- F270Words in reg. 8(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 3(2)(b) and words in reg. 8(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 3(2)(b)
- F271Words in reg. 8(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 3(2)(c) and words in reg. 8(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 3(2)(c)
- F272Words in reg. 8(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 3(2)(d)(i) and words in reg. 8(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 3(2)(d)(i)
- F273Word in reg. 8(1) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 3(2)(d)(ii) and word in reg. 8(1) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 3(2)(d)(ii)
- F274Words in reg. 8(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 3(2)(d)(iii) and words in reg. 8(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 3(2)(d)(iii)
- F275Word in reg. 8(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 3(2)(e) and word in reg. 8(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 3(2)(e)
- F276Reg. 20(1)(cd) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 4(2)(a) and reg. 20(1)(cd) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 4(2)(a)
- F277Reg. 20(1)(d)(viii) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 4(2)(b) and reg. 20(1)(d)(viii) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 4(2)(b)
- F278Words in reg. 213(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 5(2)(a) and words in reg. 213(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 5(2)(a)
- F279Words in reg. 213(1) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 5(2)(b) and words in reg. 213(1) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 5(2)(b)
- F280Words in reg. 213(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 5(2)(c) and words in reg. 213(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 5(2)(c)
- F281Reg. 214(5D) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 6 and reg. 214(5D) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 6
- F282Word in reg. 223(3)(b)(ix) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 7(2)(a) and word in reg. 223(3)(b)(ix) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 7(2)(a)
- F283Reg. 223(3)(b)(xi) and preceding word inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 7(2)(b) and reg. 223(3)(b)(xi) and preceding word inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 7(2)(b)
- F284Word in reg. 228(2)(d)(ii) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 8(2)(a) and word in reg. 228(2)(d)(ii) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 8(2)(a)
- F285Reg. 228(2)(d)(iv) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 8(2)(b) and reg. 228(2)(d)(iv) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 8(2)(b)
- F286Words in reg. 229(2) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 9 and words in reg. 229(2) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 9
- F287Words in reg. 248(1)(a) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 10(2) and words in reg. 248(1)(a) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 10(2)
- F288Words in reg. 248(2)(a) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 10(3) and words in reg. 248(2)(a) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 10(3)
- F289Words in reg. 346(2)(c)(xxviiiba) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(a)(i) and words in reg. 346(2)(c)(xxviiiba) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(a)(i)
- F290Reg. 346(2)(c)(xxviiieb) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(a)(ii) and reg. 346(2)(c)(xxviiieb) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(a)(ii)
- F291Word in reg. 346(2)(d)(ivaa) substituted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(b)(ii) and word in reg. 346(2)(d)(ivaa) substituted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(b)(ii)
- F292Sch. 23 para. 1(a)(x) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 13(2)(b) and Sch. 23 para. 1(a)(x) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 13(2)(b)
- F293Word in Sch. 23 para. 1(a)(viii) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 13(2)(a) and word in Sch. 23 para. 1(a)(viii) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 13(2)(a)
- F294Reg. 94A and cross-heading inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 8 and reg. 94A and cross-heading inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 8
- F295Reg. 226A inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 9 and reg. 226A inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 9
- F296Words in reg. 8(1) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 3 and words in reg. 8(1) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 3
- F297Word in reg. 323(3)(b) omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 14(a)(i) and word in reg. 323(3)(b) omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 14(a)(i)
- F298Reg. 323(3)(d) and preceding word inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 14(a)(ii) and reg. 323(3)(d) and preceding word inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 14(a)(ii)
- F299Reg. 346(2)(c)(xxviiieb) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 16(a)(v) and reg. 346(2)(c)(xxviiieb) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 16(a)(v)
- F300Reg. 346(2)(d)(ivab) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 16(b)(ii) and reg. 346(2)(d)(ivab) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 16(b)(ii)
- F301Sch. 7 para. 12(c) and preceding word inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(b) and Sch. 7 para. 12(c) and preceding word inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(b)
- F302Word in Sch. 7 para. 12(a) omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(a) and word in Sch. 7 para. 12(a) omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(a)
- F303Word in Sch. 17 Pt. 5 substituted (21.4.2019) by The Carriage of Dangerous Goods (Amendment) Regulations 2019 (S.I. 2019/598), regs. 1, 10
- F304Words in Sch. 17 Pt. 5 substituted (E.W.S.) (22.5.2019) by The Radiation (Emergency Preparedness and Public Information) Regulations 2019 (S.I. 2019/703), reg. 1(1), Sch. 10 para. 10(3) (with reg. 3)
- F305Words in reg. 8(1) substituted (E.W.S.) (22.5.2019) by The Radiation (Emergency Preparedness and Public Information) Regulations 2019 (S.I. 2019/703), reg. 1(1), Sch. 10 para. 10(2) (with reg. 3)
- F306Words in reg. 8(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 30(a); S.I. 2019/1436, reg. 2(b)
- F307Words in reg. 8(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 30(b); S.I. 2019/1436, reg. 2(b)
- F308Words in reg. 8(1) inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(3), 3 and inserted (N.I) (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(3), 3
- F309Reg. 19(4A)-(4D) inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(3), 4 and reg. 19(4A)-(4D) inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(3), 4
- F310Reg. 174A inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(3), 6 and reg. 174A inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(3), 6
- F311Words in Sch. 17 Pt. 2 inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(3), 32(2) and words in Sch. 17 Pt. 2 inserted (N.I.) (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(3), 32(2)
- F312Words in Sch. 17 Pt. 3 inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(3), 32(3) and words in Sch. 17 Pt. 3 inserted (N.I.) (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(3), 32(3)
- F313Words in Sch. 17 Pt. 5 inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(3), 32(4) and words in Sch. 17 Pt. 5 inserted (N.I.) (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(3), 32(4)
- F314Reg. 291A inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 24 and reg. 291A inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 24
- F315Words in reg. 41(11) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 5 and words in reg. 41(11) inserted (N.I) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 5
- F316Words in reg. 247(3)(b) substituted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 13 and words in reg. 247(3)(b) substituted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 13
- F317Reg. 250(4A) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 15 and reg. 250(4A) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349)
- F318Words in reg. 277(1) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 16 and words in reg. 277(1) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 16
- F319Reg. 280(4) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 18 and reg. 280(4) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 18
- F320Reg. 281(1A) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 19 and reg. 281(1A) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 19
- F321Words in reg. 284(2) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 20 and words in reg. 284(2) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 20
- F322Words in reg. 285(2) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 21 and words in reg. 285(2) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 21
- F323Words in reg. 287(5) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 22 and words in reg. 287(5) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 22
- F324Reg. 291(5) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 23 and reg. 291(5) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 23
- F325Words in reg. 294(2)(a) substituted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 26(2) and words in reg. 294(2)(a) substituted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 26(2)
- F326Reg. 294(2C) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 26(3) and reg. 294(2C) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 26(3)
- F327Words in reg. 297(1)(a) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 28(2) and words in reg. 297(1)(a) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 28(2)
- F328Reg. 297(1A) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 28(3) and reg. 297(1A) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 28(3)
- F329Reg. 345(3)(aa) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 29(a) and reg. 345(3)(aa) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 29(a)
- F330Words in reg. 345(3)(c) substituted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 29(b) and words in reg. 345(3)(c) substituted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 29(b)
- F331Word in reg. 345(3)(d) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 29(c) and word in reg. 345(3)(d) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 29(c)
- F332Reg. 345(3)(e) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 29(d) and inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 29(d)
- F333Reg. 346(2)(c)(xxviiiaa) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 30(a) and reg. 346(2)(c)(xxviiiaa) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 30(a)
- F334Reg. 346(2)(c)(xxviiiga) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 30(b) and reg. 346(2)(c)(xxviiiga) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 30(b)
- F335Word in Sch. 1 para. 1(f) omitted (6.11.2020) by virtue of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(2)(a) and word in Sch. 1 para. 1(f) omitted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(2)(a)
- F336Word in Sch. 1 para. 1(g) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(2)(b) and word in Sch. 1 para. 1(g) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(2)(b)
- F337Sch. 1 para. 1(h) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(2)(c) and Sch. 1 para. 1(h) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(2)(c)
- F338Word in Sch. 1 para. 3(c) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(3)(a) and word in Sch. 1 para. 3(c) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(3)(a)
- F339Sch. 1 para. 3(d) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(3)(b) and Sch. 1 para. 3(d) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(3)(b)
- F340Words in Sch. 30 para. 2 inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 33(2) and words in Sch. 30 para. 2 inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 33(2)
- F341Words in Sch. 30 para. 6 inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 33(3) and words in Sch. 30 para. 6 inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 33(3)
- F342Words in Sch. 30 para. 7 inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 33(4) and words in Sch. 30 para. 7 inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 33(4)
- F343Reg. 3A inserted (19.12.2020) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(2), 4 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(2), 4
- F344Reg. 229(2A) inserted (19.12.2020) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(2), 5(b) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(2), 5(b)
- F345Words in reg. 229(1) inserted (19.12.2020) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(2), 5(a) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(2), 5(a)
- F346Reg. 233(8)(9) inserted (19.12.2020) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(2), 8(b) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(2), 8(b)
- F347Regs. 51-51B substituted for reg. 51 (31.12.2020) by S.I. 2019/775, regs. 1, 56 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 41)
- F348Reg. 2A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 4 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 1); 2020 c. 1, Sch. 5 para. 1(1)
- F349Reg. 18A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 16; 2020 c. 1, Sch. 5 para. 1(1)
- F350Regs. 45AA, 45AB inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 37 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 27); 2020 c. 1, Sch. 5 para. 1(1)
- F351Regs. 50A-50J inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 53 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 40(a)-(g)); 2020 c. 1, Sch. 5 para. 1(1)
- F352Regs. 58A-58G inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 64 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 47); 2020 c. 1, Sch. 5 para. 1(1)
- F353Regs. 52-52B substituted for reg. 52 (31.12.2020) by S.I. 2019/775, regs. 1, 57 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 42)
- F354Regs. 53-53B substituted for reg. 53 (31.12.2020) by S.I. 2019/775, regs. 1, 58 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 43)
- F355Reg. 64A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 70 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 53); 2020 c. 1, Sch. 5 para. 1(1)
- F356Regs. 65B, 65C inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 72 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 54); 2020 c. 1, Sch. 5 para. 1(1)
- F357Reg. 66B inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 76; 2020 c. 1, Sch. 5 para. 1(1)
- F358Regs. 78A, 78B inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 87 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 64); 2020 c. 1, Sch. 5 para. 1(1)
- F359Reg. 124A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 109; 2020 c. 1, Sch. 5 para. 1(1)
- F360Reg. 125A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 111; 2020 c. 1, Sch. 5 para. 1(1)
- F361Reg. 126A and cross-heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 112 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 83); 2020 c. 1, Sch. 5 para. 1(1)
- F362Reg. 130A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 117 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 88); 2020 c. 1, Sch. 5 para. 1(1)
- F363Regs. 60A, 60B inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 67 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 50); 2020 c. 1, Sch. 5 para. 1(1)
- F364Reg. 143A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 126 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 95); 2020 c. 1, Sch. 5 para. 1(1)
- F365Reg. 148A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 130; 2020 c. 1, Sch. 5 para. 1(1)
- F366Reg. 186A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 146; 2020 c. 1, Sch. 5 para. 1(1)
- F367Reg. 202A and cross-heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 163; 2020 c. 1, Sch. 5 para. 1(1)
- F368Reg. 196A inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 156 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 124); 2020 c. 1, Sch. 5 para. 1(1)
- F369Reg. 205A and cross-heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 167 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 134); 2020 c. 1, Sch. 5 para. 1(1)
- F370Reg. 205B and cross-heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 169; 2020 c. 1, Sch. 5 para. 1(1)
- F371Regs. 257C-257E inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 200 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 154); 2020 c. 1, Sch. 5 para. 1(1)
- F372Reg. 331A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 223 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 182); 2020 c. 1, Sch. 5 para. 1(1)
- F373Regs. 344A, 344B inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 225 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 185); 2020 c. 1, Sch. 5 para. 1(1)
- F374Reg. 347A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 228(1); 2020 c. 1, Sch. 5 para. 1(1)
- F375Reg. A81 inserted (31.12.2020) by S.I. 2019/775, regs. 1, 90 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 67)
- F376Sch. 2A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 3; 2020 c. 1, Sch. 5 para. 1(1)
- F377Sch. 4 para. 23A inserted by S.I. 2019/775, regs. 1, 20(4B) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(d))
- F378Words in Sch. 4 Pt. 2 heading inserted (31.12.2020) by S.I. 2019/775, regs. 1, 20(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(c))
- F379Words in Sch. 9 heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 52(2); 2020 c. 1, Sch. 5 para. 1(1)
- F380Sch. 9A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 4 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 191); 2020 c. 1, Sch. 5 para. 1(1)
- F381Sch. 8B inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 2 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 189); 2020 c. 1, Sch. 5 para. 1(1)
- F382Sch. 10A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 5; 2020 c. 1, Sch. 5 para. 1(1)
- F383Sch. 11 Pt. 1A inserted by S.I. 2019/775, reg. 63(3A) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(5)); 2020 c. 1, Sch. 5 para. 1(1)
- F384Words in Sch. 11 Pt. 3 heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(8)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F385Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)
- F386Pt. 3 Ch. 1A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 13 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 8); 2020 c. 1, Sch. 5 para. 1(1)
- F387Sch. 8C inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 2A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 190)
- F388Sch. 8 para. 25A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 50(9) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(h)); 2020 c. 1, Sch. 5 para. 1(1)
- F389Sch. 8 para. 36 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 50(10) (as amended by (S.I. 2020/1488, reg. 1, Sch. 2 para. 38(i)); 2020 c. 1, Sch. 5 para. 1(1)
- F390Pt. 7 cross-heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 108; 2020 c. 1, Sch. 5 para. 1(1)
- F391Words in reg. 38 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 29(2) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 19(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F392Words in Sch. 17 Pt. 1 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 193(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 147(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F393Words in Sch. 17 Pt. 4 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 193(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 147(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F394Sch. 24 Pts. 4, 5 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 201(5) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 155(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F395Sch. 27 Pt. 3 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 204(6) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(e)); 2020 c. 1, Sch. 5 para. 1(1)
- F396Sch. 33 paras. 5-10 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 140); 2020 c. 1, Sch. 5 para. 1(1)
- F397Sch. 30 para. 2A inserted by S.I. 2019/775, regs. 1, 216(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 175)
- F398Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)
- F399Words in reg. 210A heading inserted (31.12.2020) by S.I. 2019/775, reg. 175(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(a))
- F400Words in reg. 195 heading omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 155(2); 2020 c. 1, Sch. 5 para. 1(1)
- F401Words in reg. 196 cross-heading inserted (31.12.2020) by S.I. 2019/775, reg. 156(ZA)(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)
- F402Words in reg. 217A heading omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 183(2); 2020 c. 1, Sch. 5 para. 1(1)
- F403Words in reg. 218 heading substituted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(2); 2020 c. 1, Sch. 5 para. 1(1)
- F404Words in reg. 219A heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 186(2); 2020 c. 1, Sch. 5 para. 1(1)
- F405Reg. 256ZA inserted (31.12.2020) by S.I. 2019/775, regs. 1, 197(1) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F406Words in reg. 268 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 207(1A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F407Words in reg. 269 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 208(1A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F408Words in reg. 8(1) omitted (31.12.2020) by virtue of The European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/593), reg. 1(2), Sch. 2 para. 42(a) (with reg. 12A, Sch. 2 Pt. 2) (as amended by S.I. 2020/1394, regs. 4, 10(3)-(7)); 2020 c. 1, Sch. 5 para. 1(1)
- F409Words in reg. 8(1) omitted (31.12.2020) by virtue of The European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/593), reg. 1(2), Sch. 2 para. 42(b)(i) (with reg. 12A, Sch. 2 Pt. 2) (as amended by S.I. 2020/1394, regs. 4, 10(3)-(7)); 2020 c. 1, Sch. 5 para. 1(1)
- F410Words in reg. 8(1) omitted (31.12.2020) by virtue of The European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/593), reg. 1(2), Sch. 2 para. 42(b)(ii) (with reg. 12A, Sch. 2 Pt. 2) (as amended by S.I. 2020/1394, regs. 4, 10(3)-(7)); 2020 c. 1, Sch. 5 para. 1(1)
- F411Words in reg. 8(1) omitted (31.12.2020) by virtue of The European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/593), reg. 1(2), Sch. 5 para. 24(a) (with reg. 12A, Sch. 5 Pt. 2) (as amended by S.I. 2020/1394, regs. 4, 13); 2020 c. 1, Sch. 5 para. 1(1)
- F412Words in reg. 8(1) omitted (31.12.2020) by virtue of The European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/593), reg. 1(2), Sch. 5 para. 24(b) (with reg. 12A, Sch. 5 Pt. 2) (as amended by S.I. 2020/1394, regs. 4, 13); 2020 c. 1, Sch. 5 para. 1(1)
- F413Words in reg. 8(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F414Words in reg. 8(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(iii)); 2020 c. 1, Sch. 5 para. 1(1)
- F415Words in reg. 8(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(c); 2020 c. 1, Sch. 5 para. 1(1)
- F416Words in reg. 8(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(e) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(v)); 2020 c. 1, Sch. 5 para. 1(1)
- F417Word in reg. 8(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(f); 2020 c. 1, Sch. 5 para. 1(1)
- F418Words in reg. 8(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(g); 2020 c. 1, Sch. 5 para. 1(1)
- F419Words in reg. 8(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(h); 2020 c. 1, Sch. 5 para. 1(1)
- F420Words in reg. 8(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(i); 2020 c. 1, Sch. 5 para. 1(1)
- F421Words in reg. 8(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(4)(iii); 2020 c. 1, Sch. 5 para. 1(1)
- F422Words in reg. 8(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(4)(v); 2020 c. 1, Sch. 5 para. 1(1)
- F423Words in reg. 8(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(4)(vi); 2020 c. 1, Sch. 5 para. 1(1)
- F424Words in reg. 8(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(4)(xiii); 2020 c. 1, Sch. 5 para. 1(1)
- F425Word in reg. 8(5)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(5); 2020 c. 1, Sch. 5 para. 1(1)
- F426Word in reg. 8(6)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(6)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F427Words in reg. 8(6)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(6)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F428Words in reg. 8(8) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(7); 2020 c. 1, Sch. 5 para. 1(1)
- F429Reg. 8(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(8) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F430Words in reg. 8(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(j) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(vi)); 2020 c. 1, Sch. 5 para. 1(1)
- F431Words in reg. 8(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(k) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(vii)); 2020 c. 1, Sch. 5 para. 1(1)
- F432Reg. 43(8A)(8B) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(6) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(i)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
- F433Words in reg. 43(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(5A)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(h)); 2020 c. 1, Sch. 5 para. 1(1)
- F434Words in reg. 43(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(5A)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(h)); 2020 c. 1, Sch. 5 para. 1(1)
- F435Words in reg. 43(15) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(10) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(l)); 2020 c. 1, Sch. 5 para. 1(1)
- F436Words in reg. 43(6)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(4)(aa) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F437Reg. 43(6)(ba) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(4)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(d)(i)(ii)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)
- F438Reg. 43(6)(d) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(4)(c) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(e)); 2020 c. 1, Sch. 5 para. 1(1)
- F439Reg. 43(1) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 33(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(a))
- F440Reg. 43(5)(a) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 33(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(b))
- F441Words in reg. 43(6)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F442Reg. 43(7)(b)(i) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 33(5)(a)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(f)(i))
- F443Reg. 43(7)(b)(ii) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 33(5)(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 23(f)(ii))
- F444Words in reg. 43(13) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(8) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(k)); 2020 c. 1, Sch. 5 para. 1(1)
- F445Reg. 43(14) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 33(9) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(l))
- F446Word in reg. 3(12)(d)(i) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 5(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F447Word in reg. 3(15)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 5(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F448Word in reg. 4(4)(d)(i) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 6(a)(i) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 3); 2020 c. 1, Sch. 5 para. 1(1)
- F449Words in reg. 4(6) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 6(b) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 3); 2020 c. 1, Sch. 5 para. 1(1)
- F450Words in regs. 256C-256M substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 197(4) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 151); 2020 c. 1, Sch. 5 para. 1(1)
- F451Word in Sch. 9 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 52(3); 2020 c. 1, Sch. 5 para. 1(1)
- F452Words in reg. 5(2)(d) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 7(3)(b) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(b)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
- F453Words in reg. 5(4)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 7(5) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F454Words in reg. 8(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(zb) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(i)); 2020 c. 1, Sch. 5 para. 1(1)
- F455Words in reg. 8(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 10(3)(a) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
- F456Reg. 17(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 14(2) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 9(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F457Reg. 17(4)(aa) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 14(4) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 9(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F458Words in reg. 17(5) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 14(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 9(d))
- F459Reg. 17(7)(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 14(6) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 9(e)); 2020 c. 1, Sch. 5 para. 1(1)
- F460Word in reg. 18(1)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F461Words in reg. 18(1)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F462Reg. 18(1)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(2)(c) (as amended S.I. 2020/1488, reg. 1, Sch. 2 para. 10(a)(i)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
- F463Reg. 18(2A)(2B) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(2A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 10(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F464Reg. 18(6) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(3) (as substituted by (S.I. 2020/1488, reg. 1, Sch. 2 para. 10(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F465Reg. 19(1)(a) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 17(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 11(a))
- F466Words in reg. 19(1)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 17(3); 2020 c. 1, Sch. 5 para. 1(1)
- F467Reg. 19(6) inserted (31.12.2020) by S.I. 2019/775, regs. 1, 17(4) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 11(b))
- F468Words in reg. 23(1)(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 19; 2020 c. 1, Sch. 5 para. 1(1)
- F469Reg. 24(3) inserted (31.12.2020) by S.I. 2019/775, regs. 1, 19A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 13)
- F470Reg. 26(5)(a) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 21 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 15)
- F471Word in reg. 29(5)(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 23(a); 2020 c. 1, Sch. 5 para. 1(1)
- F472Words in reg. 29(5)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 23(b); 2020 c. 1, Sch. 5 para. 1(1)
- F473Reg. 29(5)(d) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 23(c); 2020 c. 1, Sch. 5 para. 1(1)
- F474Words in reg. 31(1)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 24(2); 2020 c. 1, Sch. 5 para. 1(1)
- F475Words in reg. 31(3)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 24(3) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 16); 2020 c. 1, Sch. 5 para. 1(1)
- F476Words in reg. 31(5)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 24(3) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 16); 2020 c. 1, Sch. 5 para. 1(1)
- F477Words in reg. 31(5)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 24(3) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 16); 2020 c. 1, Sch. 5 para. 1(1)
- F478Words in reg. 33(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 25(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F479Words in reg. 33(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 25(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F480Words in reg. 33(1)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 25(3); 2020 c. 1, Sch. 5 para. 1(1)
- F481Words in reg. 33(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 25(4); 2020 c. 1, Sch. 5 para. 1(1)
- F482Words in reg. 37(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(1A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 18(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F483Reg. 37(4)(b) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 28(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 18(b))
- F484Words in reg. 37(5)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(3) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 18(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F485Reg. 37(6)(b) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 28(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 18(d))
- F486Words in reg. 37(9)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(5); 2020 c. 1, Sch. 5 para. 1(1)
- F487Words in reg. 37(11) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(6)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F488Word in reg. 37(11) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(6)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F489Reg. 38(2)(a)(b) substituted for words in reg. 38(2) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 29(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 19(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F490Words in reg. 38(3)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 29(4) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 19(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F491Words in reg. 42(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 31(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 21(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F492Reg. 45E(3)(b)(i) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 40(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 29(a))
- F493Words in reg. 44(2)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 35(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 25(a)(i)); 2020 c. 1, Sch. 5 para. 1(1)
- F494Reg. 44(2)(c) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 35(2)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(a)(ii))
- F495Reg. 44(5)(b) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 35(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(b))
- F496Reg. 44(5)(e) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 35(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(c))
- F497Word in reg. 44(6)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 35(5)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F498Reg. 44(8)-(10) inserted (31.12.2020) by S.I. 2019/775, regs. 1, 35(6) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(e))
- F499Reg. 45(1A) inserted (31.12.2022) The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 36(2) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 26(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F500Reg. 45(2)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 36(3) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 26(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F501Reg. 45A(1)(1A) substituted for reg. 45A(1) (31.12.2020) by S.I. 2019/775, regs. 1, 38(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 28(a))
- F502Words in reg. 45A(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(3)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F503Words in reg. 45A(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(3)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F504Words in reg. 45A(2)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(3)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F505Reg. 45A(3) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(4); 2020 c. 1, Sch. 5 para. 1(1)
- F506Reg. 45D(1)(b)(ii) and word omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 39; 2020 c. 1, Sch. 5 para. 1(1)
- F507Reg. 45M(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 42(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 31); 2020 c. 1, Sch. 5 para. 1(1)
- F508Words in reg. 45M(3) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 42(3); 2020 c. 1, Sch. 5 para. 1(1)
- F509Reg. 45O(1)(1A) substituted for reg. 45O(1) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F510Reg. 45O(2)(2A) substituted for reg. 45O(2) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F511Words in reg. 45O(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F512Words in reg. 45O(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F513Words in reg. 45O(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(c) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F514Words in reg. 45O(3)(c)(ii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(d) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F515Reg. 45O(3A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 32(d))
- F516Words in reg. 45O(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(5)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e)); 2020 c. 1, Sch. 5 para. 1(1)
- F517Words in reg. 45O(4)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(5)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e)); 2020 c. 1, Sch. 5 para. 1(1)
- F518Words in reg. 45O(4)(b)(i) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(5)(c) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e)); 2020 c. 1, Sch. 5 para. 1(1)
- F519Reg. 45O(6)-(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(6) (as amended by S.I. 2020/1488, Sch. 2 para. 32(f)); 2020 c. 1, Sch. 5 para. 1(1)
- F520Word in reg. 46(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F521Words in reg. 46(3) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(3); 2020 c. 1, Sch. 5 para. 1(1)
- F522Words in reg. 46(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(4)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F523Word in reg. 46(6)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(4)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F524Words in reg. 46(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(6); 2020 c. 1, Sch. 5 para. 1(1)
- F525Words in reg. 46(11)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(7); 2020 c. 1, Sch. 5 para. 1(1)
- F526Words in reg. 47(3) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 46(2); 2020 c. 1, Sch. 5 para. 1(1)
- F527Words in reg. 47(4) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 46(2); 2020 c. 1, Sch. 5 para. 1(1)
- F528Words in reg. 48(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(a)(i)); 2020 c. 1, Sch. 5 para. 1(1)
- F529Words in reg. 48(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F530Words in reg. 48(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(c); 2020 c. 1, Sch. 5 para. 1(1)
- F531Words in reg. 48(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(d) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F532Reg. 48(3)-(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F533Words in reg. 49(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 48(2); 2020 c. 1, Sch. 5 para. 1(1)
- F534Reg. 49(1A)-(1C) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 48(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 36(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F535Reg. 49(3) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 48(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 36(b))
- F536Reg. 49(3A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 48(5); 2020 c. 1, Sch. 5 para. 1(1)
- F537Reg. 49(9)(10) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 48(6) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 36(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F538Reg. 50(3A) inserted (31.12.2020) by S.I. 2019/775, regs. 1, 49(1B) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(a))
- F539Reg. 50(4) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 49(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(b))
- F540Reg. 50(5A)-(5C) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 37(c)(i)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
- F541Reg. 50(6)(za)-(zg) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(4); 2020 c. 1, Sch. 5 para. 1(1)
- F542Reg. 50(6)(a)-(ab) substituted for reg. 50(6)(a) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(4A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 37(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F543Reg. 50(6)(b)-(bb) substituted for reg. 50(6)(b) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(4A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 37(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F544Reg. 50(6)(c)-(cb) substituted for reg. 50(6)(c) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(4A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 37(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F545Reg. 50(7)(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(5); 2020 c. 1, Sch. 5 para. 1(1)
- F546Reg. 50(1A) inserted after subparagraph (1) (31.12.2020) by virtue of S.I. 2019/775, regs. 1, 49(1A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(a))
- F547Regs. 58(4A)-(4C) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 45(a); 2020 c. 1, Sch. 5 para. 1(1)
- F548Reg. 58(8)(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(4) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 45(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F549Words in reg. 54(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 59(2); 2020 c. 1, Sch. 5 para. 1(1)
- F550Reg. 54(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 59(3); 2020 c. 1, Sch. 5 para. 1(1)
- F551Reg. 55 substituted (31.12.2020) by S.I. 2019/775, reg. 60 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 44)
- F552Words in reg. 56(2) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 61; 2020 c. 1, Sch. 5 para. 1(1)
- F553Words in reg. 59(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 65(1A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 48(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F554Reg. 59(3A)-(3C) inserted (31.12.2020) by S.I. 2019/775, reg. 65(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 48(c))
- F555Word in reg. 59(4) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 65(4); 2020 c. 1, Sch. 5 para. 1(1)
- F556Reg. 59(4A)-(4E) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 65(5); 2020 c. 1, Sch. 5 para. 1(1)
- F557Words in reg. 59(5) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 65(6) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 48(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F558Words in reg. 60 inserted (31.12.2020) by S.I. 2019/775, reg. 66(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)
- F559Words in reg. 60 inserted (31.12.2020) by S.I. 2019/775, reg. 66(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)
- F560Words in reg. 60(3) inserted (31.12.2020) by S.I. 2019/775, reg. 66(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)
- F561Reg. 60(9) substituted (31.12.2020) by S.I. 2019/775, reg. 66(d) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)
- F562Words in reg. 60(10) inserted (31.12.2020) by S.I. 2019/775, reg. 66(e) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)
- F563Reg. 61(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 68(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 51(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F564Words in reg. 61(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 68(2A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 51(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F565Reg. 61(6A) inserted (31.12.2020) by S.I. 2019/775, reg. 68(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 51(c))
- F566Reg. 61(7A)-(7C) inserted (31.12.2020) by S.I. 2019/775, reg. 68(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 51(e))
- F567Words in reg. 61(13) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775) (S.I. 2019/775), reg. 68(5) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 51(f)); 2020 c. 1, Sch. 5 para. 1(1)
- F568Reg. 64(4)(d) substituted (31.12.2020) by S.I. 2019/775, reg. 69 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 52)
- F569Reg. 65(5)(za) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 71; 2020 c. 1, Sch. 5 para. 1(1)
- F570Reg. 66(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 74 (as amended by (S.I. 2020/1488), reg. 1, Sch. 2 para. 55); 2020 c. 1, Sch. 5 para. 1(1)
- F571Words in reg. 66A(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 75; 2020 c. 1, Sch. 5 para. 1(1)
- F572Words in reg. 68(5) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(2); 2020 c. 1, Sch. 5 para. 1(1)
- F573Words in reg. 68(7) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F574Reg. 68(7)(a)(b) and words substituted for words (31.12.2020) by S.I. 2019/775, reg. 77(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 57(a))
- F575Words in reg. 68(8)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(4); 2020 c. 1, Sch. 5 para. 1(1)
- F576Words in reg. 68(9)(a) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 77(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 57(b))
- F577Words in reg. 68(10)(a) substituted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(6)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F578Reg. 68(10)(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(6)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F579Words in reg. 68(11)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(7); 2020 c. 1, Sch. 5 para. 1(1)
- F580Reg. 68(11B)-(11G) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(8) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 57(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F581Words in reg. 68(12) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(9)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F582Words in reg. 68(12) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(9)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F583Reg. 68(13) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(10); 2020 c. 1, Sch. 5 para. 1(1)
- F584Reg. 69(10) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 78; 2020 c. 1, Sch. 5 para. 1(1)
- F585Reg. 70 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 79; 2020 c. 1, Sch. 5 para. 1(1)
- F586Reg. 71(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 80(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F587Words in reg. 73(5C) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 82(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 60)
- F588Words in reg. 73(5A)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 82(2); 2020 c. 1, Sch. 5 para. 1(1)
- F589Reg. 75(5)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 83(a); 2020 c. 1, Sch. 5 para. 1(1)
- F590Word in reg. 75(5)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 83(b); 2020 c. 1, Sch. 5 para. 1(1)
- F591Reg. 76(2) substituted (31.12.2020) by S.I. 2019/775, reg. 84 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 61)
- F592Words in reg. 79(1) substituted (31.12.2020) by S.I. 2019/775, reg. 88(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 65)
- F593Words in reg. 79(2) substituted (31.12.2020) by S.I. 2019/775, reg. 88(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 65)
- F594Word in reg. 80 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 89(2); 2020 c. 1, Sch. 5 para. 1(1)
- F595Reg. 80(a) substituted (31.12.2020) by S.I. 2019/775, reg. 89(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(a))
- F596Reg. 80(b) substituted (31.12.2020) by S.I. 2019/775, reg. 89(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(b))
- F597Words in reg. 80(c) inserted (31.12.2020) by S.I. 2019/775, reg. 89(4A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(c))
- F598Reg. 80(d) inserted (31.12.2020) by S.I. 2019/775, reg. 89(5) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(d)(ii)(iii)); 2020 c. 1, Sch. 5 para. 1(1)
- F599Words in reg. 89(1)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 90A (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 67)
- F600Reg. 91 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 90B (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 67)
- F601Words in reg. 97(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 94(3); 2020 c. 1, Sch. 5 para. 1(1)
- F602Reg. 102(7)(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 98 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 75); 2020 c. 1, Sch. 5 para. 1(1)
- F603Reg. 103(1A)(1B) inserted (31.12.2020) by S.I. 2019/775, reg. 99(1A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 76(a))
- F604Reg. 103(4)(a)-(c) substituted for words in reg. 103(4) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 99(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 76(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F605Reg. 103(5A)(5B) inserted (31.12.2020) by S.I. 2019/775, reg. 99(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 76(c))
- F606Words in reg. 103(8)(e) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 99(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
- F607Words in reg. 103(8)(e) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 99(3)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
- F608Words in reg. 103(8)(f) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 99(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F609Reg. 104(7)(8) inserted (31.12.20200 by S.I. 2019/775, reg. 100(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 77)
- F610Reg. 108(2)(a)-(c) substituted for words in reg. 108(2) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 101 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 78); 2020 c. 1, Sch. 5 para. 1(1)
- F611Words in reg. 109(1) inserted (31.12.2020) by S.I. 2019/775, reg. 101A(2) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 79)
- F612Words in reg. 109(2) inserted (31.12.2020) by S.I. 2019/775, reg. 101A(3) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 79)
- F613Reg. 110(7)(a)(b) substituted for words in reg. 110(7) (31.12.2020) by S.I. 2019/775, reg. 102(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 80(a))
- F614Reg. 110(8B) inserted (31.12.20200 by S.I. 2019/775, reg. 102(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 80(b))
- F615Reg. 111 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 103; 2020 c. 1, Sch. 5 para. 1(1)
- F616Words in reg. 112(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 104; 2020 c. 1, Sch. 5 para. 1(1)
- F617Words in reg. 113(3A) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 105; 2020 c. 1, Sch. 5 para. 1(1)
- F618Words in reg. 115(5)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 106; 2020 c. 1, Sch. 5 para. 1(1)
- F619Reg. 116(2) substituted (31.12.2020) by S.I. 2019/775, reg. 107 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 81)
- F620Reg. 125(5)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 110 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 82); 2020 c. 1, Sch. 5 para. 1(1)
- F621Reg. 127(1A)(1B) inserted (31.12.2020) by S.I. 2019/775, reg. 113(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 84)
- F622Reg. 127(3)(a)-(c) substituted for words in reg. 127(3) (31.12.2020) by S.I. 2019/775, reg. 113(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 84)
- F623Reg. 127(4A) inserted (31.12.2020) by S.I. 2019/775, reg. 113(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 84)
- F624Reg. 128(1)(1A) substituted for reg. 128(1) (31.12.2020) by S.I. 2019/775, reg. 114(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 85)
- F625Words in reg. 128(3) inserted (31.12.2020) by S.I. 2019/775, reg. 114(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 85)
- F626Word in reg. 130(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 116(2); 2020 c. 1, Sch. 5 para. 1(1)
- F627Reg. 130(7)(a)(b) substituted for words in reg. 130(7) (31.12.2020) by S.I. 2019/775, reg. 116(3) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F628Words in reg. 130(8) inserted (31.12.2020) by S.I. 2019/775, reg. 116(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(b)) 2020 c. 1, Sch. 5 para. 1(1)
- F629Words in reg. 130(9) inserted (31.12.2020) by S.I. 2019/775, reg. 116(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(c))
- F630Reg. 130(10)(a)(i)(ii) substituted for words in reg. 130(10)(a) (31.12.2020) by S.I. 2019/775, reg. 116(6) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F631Words in reg. 130(12) inserted (31.12.2020) by S.I. 2019/775, reg. 116(7) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(e))
- F632Reg. 130(14)(15) inserted (31.12.2020) by S.I. 2019/775, reg. 116(8) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(f))
- F633Reg. 133(2)(a)-(c) substituted for words in reg. 133(2) (31.12.2020) by S.I. 2019/775, reg. 18 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 89); 2020 c. 1, Sch. 5 para. 1(1)
- F634Words in reg. 134(1) inserted (31.12.2020) by S.I. 2019/775, reg. 118A(2) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 90)
- F635Words in reg. 134(2) inserted (31.12.2020) by S.I. 2019/775, reg. 118A(3) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 90)
- F636Reg. 135(6) substituted (31.12.2020) by S.I. 2019/775, reg. 119(1A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(a))
- F637Words in reg. 135(7)(b) inserted (31.12.2020) by S.I. 2019/775, reg. 119(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F638Words in reg. 135(8)(a) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 119(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(c))
- F639Words in reg. 135(9)(b) inserted (31.12.2020) by S.I. 2019/775, reg. 119(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F640Reg. 135(10B) inserted (31.12.2020) by S.I. 2019/775, reg. 119(4A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 91(e))
- F641Reg. 135(11) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 119(5); 2020 c. 1, Sch. 5 para. 1(1)
- F642Reg. 136(1)(a)(i)(ii) substituted for words in reg. 136(1)(a) (31.12.2020) by S.I. 2019/775, reg. 120(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 92); 2020 c. 1, Sch. 5 para. 1(1)
- F643Reg. 136(3) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 120(3); 2020 c. 1, Sch. 5 para. 1(1)
- F644Reg. 138(10) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 121; 2020 c. 1, Sch. 5 para. 1(1)
- F645Reg. 139 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 122; 2020 c. 1, Sch. 5 para. 1(1)
- F646Reg. 140(1)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 123 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 93); 2020 c. 1, Sch. 5 para. 1(1)
- F647Words in reg. 141(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 124; 2020 c. 1, Sch. 5 para. 1(1)
- F648Words in reg. 142(5C) substituted (31.12.2020) by S.I. 2019/775, reg. 125 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 94); 2020 c. 1, Sch. 5 para. 1(1)
- F649Reg. 144 substituted (31.12.2020) by S.I. 2019/775, reg. 127 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 96)
- F650Words in reg. 145(5)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 128; 2020 c. 1, Sch. 5 para. 1(1)
- F651Reg. 146(2) substituted (31.12.2020) by S.I. 2019/775, reg. 129 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 97)
- F652Reg. 149 substituted (31.12.2020) by S.I. 2019/775, reg. 131 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 98)
- F653Words in reg. 156(1) inserted (31.12.2020) by S.I. 2019/775, reg. 132(a)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F654Words in reg. 156(1) inserted (31.12.2020) by S.I. 2019/775, reg. 132(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F655Words in reg. 156(2) inserted (31.12.2020) by S.I. 2019/775, reg. 132(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F656Words in reg. 156(3) inserted (31.12.2020) by S.I. 2019/775, reg. 132(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F657Words in reg. 156(4) substituted (31.12.2020) by S.I. 2019/775, reg. 132(d) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F658Words in reg. 156(5) substituted (31.12.2020) by S.I. 2019/775, reg. 132(e) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F659Words in reg. 157 heading substituted (31.12.2020) by S.I. 2019/775, reg. 132A(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F660Words in reg. 157(1) inserted (31.12.2020) by S.I. 2019/775, reg. 132A(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F661Words in reg. 157(1) substituted (31.12.2020) by S.I. 2019/775, reg. 132A(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F662Word in reg. 159(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 133(a); 2020 c. 1, Sch. 5 para. 1(1)
- F663Words in reg. 159(1) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 133(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 100)
- F664Word in reg. 164(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 134(a); 2020 c. 1, Sch. 5 para. 1(1)
- F665Word in reg. 164(2)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 134(a); 2020 c. 1, Sch. 5 para. 1(1)
- F666Words in reg. 164(2)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 134(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 101)
- F667Words in reg. 164(2)(b) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 134(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 101)
- F668Words in reg. 167(6) substituted (31.12.2020) by S.I. 2019/775, reg. 135ZA(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 102)
- F669Words in reg. 167(7) substituted (31.12.2020) by S.I. 2019/775, reg. 135ZA(b)(i) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 102)
- F670Reg. 167(7)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 135ZA(b)(ii) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 102)
- F671Reg. 167(7)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 135ZA(b)(iii) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 102)
- F672Reg. 168(8) substituted (31.12.2020) by S.I. 2019/775, reg. 135 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 103)
- F673Words in reg. 169(9)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 136 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 104): 2020 c. 1, Sch. 5 para. 1(1)
- F674Words in reg. 173(c) substituted (31.12.2020) by S.I. 2019/775, reg. 138 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 106); 2020 c. 1, Sch. 5 para. 1(1)
- F675Reg. 177(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 139(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(a))
- F676Words in reg. 177(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 139(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F677Words in reg. 177(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 139(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F678Words in reg. 177(5) substituted (31.12.2020) by S.I. 2019/775, reg. 139(6)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(e))
- F679Word in reg. 177(5) omitted virtue of (31.12.2020) by S.I. 2019/775, reg. 139(6)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(e))
- F680Words in reg. 177(5) inserted (31.12.2020) by S.I. 2019/775, reg. 139(6)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(e))
- F681Words in reg. 179(1) inserted (31.12.2020) by S.I. 2019/775, reg. 139A(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 108)
- F682Reg. 179(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 139A(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 108)
- F683Words in reg. 179(2) substituted (31.12.2020) by S.I. 2019/775, reg. 139A(c) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 108)
- F684Words in reg. 179(3)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 139A(d) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 108)
- F685Words in reg. 180(1) inserted (31.12.2020) by S.I. 2019/775, reg. 140(2)(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(a)(i))
- F686Words in reg. 180(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 140(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 109(a)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
- F687Reg. 180(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 140(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(b))
- F688Words in reg. 180(2) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 140(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F689Word in reg. 180(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 140(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F690Reg. 180(3) inserted (31.12.2020) by S.I. 2019/775, reg. 140(4) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 109(c))
- F691Words in reg. 181(1) substituted (31.12.2020) by S.I. 2019/775, reg. 141 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 110)
- F692Words in reg. 182(2)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 142(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 111(a))
- F693Words in reg. 182(2)(b) inserted (31.12.2020) by S.I. 2019/775, reg. 142(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 111(b))
- F694Reg. 182(2A)(2B) inserted (31.12.2020) by S.I. 2019/775, reg. 142(2B) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 111(b))
- F695Reg. 182(3)(3A) substituted for reg. 182(3) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 111(c))
- F696Reg. 182(6) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 142(4); 2020 c. 1, Sch. 5 para. 1(1)
- F697Reg. 184(3) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 143 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 112); 2020 c. 1, Sch. 5 para. 1(1)
- F698Words in reg. 185(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 144; 2020 c. 1, Sch. 5 para. 1(1)
- F699Reg. 186(1)(d)(e) substituted (31.12.2020) by S.I. 2019/775, reg. 145(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 113)
- F700Reg. 186(4) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 145(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 113)
- F701Words in reg. 187(1) substituted (31.12.2020) by S.I. 2019/775, reg. 147(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 114)
- F702Words in reg. 187(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 147(3); 2020 c. 1, Sch. 5 para. 1(1)
- F703Words in reg. 188 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(2); 2020 c. 1, Sch. 5 para. 1(1)
- F704Words in reg. 188(1) substituted (31.12.2020) by S.I. 2019/775, reg. 148(3)(za) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(a))
- F705Words in reg. 188(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
- F706Words in reg. 188(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(3)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
- F707Words in reg. 188(1)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F708Words in reg. 188(1)(e) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(3)(c); 2020 c. 1, Sch. 5 para. 1(1)
- F709Reg. 188(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 148(3A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(b))
- F710Words in reg. 188(2) inserted (31.12.2020) by S.I. 2019/775, reg. 148(4)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(c))
- F711Words in reg. 188(2) substituted (31.12.2020) by S.I. 2019/775, reg. 148(4)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(c))
- F712Words in reg. 188(2) substituted (31.12.2020) by S.I. 2019/775, reg. 148(4)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(c))
- F713Words in reg. 188(3) substituted (31.12.2020) by S.I. 2019/775, reg. 148(4A) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(c))
- F714Words in reg. 188(4)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(5); 2020 c. 1, Sch. 5 para. 1(1)
- F715Reg. 188(4A) inserted (31.12.2020) by S.I. 2019/775, reg. 148(5A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 115(d))
- F716Words in reg. 188(5) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(6); 2020 c. 1, Sch. 5 para. 1(1)
- F717Reg. 188(6) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 148(7); 2020 c. 1, Sch. 5 para. 1(1)
- F718Words in reg. 189(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 149(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F719Words in reg. 189(1)(d) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 149(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F720Words in reg. 189(2) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 149(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 116)
- F721Words in reg. 189(3) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 149(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 116)
- F722Reg. 190(1) substituted (31.12.2020) by S.I. 2019/775, reg. 150 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 117)
- F723Words in reg. 191(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 151(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 118(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F724Words in reg. 191(7) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 15 (1(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 118(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F725Word in reg. 191(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 151(3); 2020 c. 1, Sch. 5 para. 1(1)
- F726Reg. 191(4A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 151(5) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 118(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F727Reg. 191(8A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 151(6) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 118(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F728Reg. 191(10)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 151(7)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 118(e))
- F729Reg. 191(10)(c) substituted (31.12.2020) by S.I. 2019/775, reg. 151(7)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 118(e))
- F730Reg. 191(11) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 151(8); 2020 c. 1, Sch. 5 para. 1(1)
- F731Word in reg. 192(1)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 152(2); 2020 c. 1, Sch. 5 para. 1(1)
- F732Words in reg. 192(3) inserted (31.12.2020) by S.I. 2019/775, reg. 152(3) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 119(a))
- F733Words in reg. 192(9) inserted (31.12.2020) by S.I. 2019/775, reg. 152(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 119(b))
- F734Reg. 193(1) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 153(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 120(a))
- F735Words in reg. 193(2) inserted (31.12.2020) by S.I. 2019/775, reg. 153(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 120(b))
- F736Reg. 193(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 153(3) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 120(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F737Reg. 193(4A) inserted (31.12.2020) by S.I. 2019/775, reg. 153(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 120(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F738Words in reg. 193(5) inserted (31.12.2020) by S.I. 2019/775, reg. 153(5)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 120(e)(i))
- F739Words in reg. 193(5) inserted (31.12.2020) by S.I. 2019/775, reg. 153(5)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 120(e)(ii))
- F740Reg. 193(6A)(6B) inserted (31.12.2020) by S.I. 2019/775, reg. 153(6) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 120(f)); 2020 c. 1, Sch. 5 para. 1(1)
- F741Reg. 193(7)(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 153(7); 2020 c. 1, Sch. 5 para. 1(1)
- F742Words in reg. 194(1) inserted (31.12.2020) by S.I. 2019/775, reg. 154 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 121); 2020 c. 1, Sch. 5 para. 1(1)
- F743Reg. 195(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 155(3) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 122(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F744Words in reg. 195(1) inserted (31.12.2020) by S.I. 2019/775, reg. 155(2B)(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 122(a))
- F745Words in reg. 195(1)(a)(i) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 155(2B)(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 122(a))
- F746Reg. 195(A1) inserted (31.12.2020) by S.I. 2019/775, reg. 155(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 122(a))
- F747Reg. 195(3A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 155(4); 2020 c. 1, Sch. 5 para. 1(1)
- F748Words in reg. 196(1) substituted (31.12.2020) by S.I. 2019/775, reg. 156(ZA)(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)
- F749Reg. 196(2B) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 156(ZA)(c) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)
- F750Reg. 196(4)-(7) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 156(ZA)(d) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)
- F751Words in reg. 196(8) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 156(ZA)(e) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)
- F752Words in reg. 197(1) inserted (31.12.2020) by S.I. 2019/775, reg. 157 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 125); 2020 c. 1, Sch. 5 para. 1(1)
- F753Words in reg. 198(2) renumbered as reg. 198(2)(a) (31.12.2020) by S.I. 2019/775, reg. 158(2)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(a))
- F754Words in reg. 198(2)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 158(2)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(a))
- F755Reg. 198(2)(b) inserted (31.12.2020) by S.I. 2019/775, reg. 158(2)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(a))
- F756Reg. 198(3)(c)(i)(ii) substituted for words in reg. 198(3)(c) (31.12.2020) by S.I. 2019/775, reg. 158(3)(a)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(i))
- F757Words in reg. 198(3)(c) become full-out words (31.12.2020) by S.I. 2019/775, reg. 158(3)(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(i))
- F758Words in reg. 198(3)(d) renumbered as reg. 198(3)(d)(i) (31.12.2020) by S.I. 2019/775, reg. 158(3)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii))
- F759Words in reg. 198(3)(d)(i) inserted (31.12.2020) by S.I. 2019/775, reg. 158(3)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii))
- F760Reg. 198(3)(d)(ii) inserted (31.12.2020) by S.I. 2019/775, reg. 158(3)(b)(iii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii))
- F761Words in reg. 198(3)(d) become full-out words (31.12.2020) by S.I. 2019/775, reg. 158(3)(b)(iv) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii))
- F762Reg. 199(2)(a)(b) substituted for words in reg. 199(2) (31.12.2020) by S.I. 2019/775, reg. 159(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 127(a))
- F763Word in reg. 199(4) inserted (31.12.2020) by S.I. 2019/775, reg. 159(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 127(b))
- F764Words in reg. 199(4) inserted (31.12.2020) by S.I. 2019/775, reg. 159(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 127(b))
- F765Reg. 200(2)(a)(b) substituted for words in reg. 200(2) (31.12.2020) by S.I. 2019/775, reg. 160(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 128(a))
- F766Word in reg. 200(4) inserted (31.12.2020) by S.I. 2019/775, reg. 160(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 128(b))
- F767Words in reg. 200(4) inserted (31.12.2020) by S.I. 2019/775, reg. 160(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 128(b))
- F768Reg. 201(2)(a)(b) substituted for words in reg. 201(2) (31.12.2020) by S.I. 2019/775, reg. 161(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 129(a))
- F769Words in reg. 201(4) omitted (31.12.2020) by S.I. 2019/775, reg. 161(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 129(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F770Words in reg. 202(1) inserted (31.12.2020) by S.I. 2019/775, reg. 162 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 130)
- F771Words in reg. 203(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 164(2); 2020 c. 1, Sch. 5 para. 1(1)
- F772Reg. 203(2)(da) inserted (31.12.2020) by S.I. 2019/775, reg. 164(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 131)
- F773Words in reg. 204(1) inserted (31.12.2020) by S.I. 2019/775, reg. 165 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 132); 2020 c. 1, Sch. 5 para. 1(1)
- F774Words in reg. 205(2) inserted (31.12.2020) by S.I. 2019/775, reg. 166(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 133(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F775Words in reg. 206(3) inserted (31.12.2020) by S.I. 2019/775, reg. 170(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 135)
- F776Reg. 206(4)(aa) inserted (31.12.2020) by S.I. 2019/775, reg. 170(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 135)
- F777Words in reg. 207(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 171; 2020 c. 1, Sch. 5 para. 1(1)
- F778Words in reg. 210A(1)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 175(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(b))
- F779Reg. 210A(1)(aa) inserted (31.12.2020) by S.I. 2019/775, reg. 175(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(b))
- F780Reg. 210A(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 175(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(c))
- F781Words in reg. 210A(4) inserted (31.12.2020) by S.I. 2019/775, reg. 175(5) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(d))
- F782Words in reg. 212 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 177 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 139)
- F783Words in reg. 213(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 179(a); 2020 c. 1, Sch. 5 para. 1(1)
- F784Words in reg. 213(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 179(b); 2020 c. 1, Sch. 5 para. 1(1)
- F785Words in reg. 213(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 179(c); 2020 c. 1, Sch. 5 para. 1(1)
- F786Words in reg. 214(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 180(2); 2020 c. 1, Sch. 5 para. 1(1)
- F787Words in reg. 214(6) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 180(3); 2020 c. 1, Sch. 5 para. 1(1)
- F788Reg. 214(6A)-(6C) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 180(4); 2020 c. 1, Sch. 5 para. 1(1)
- F789Words in reg. 216(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 181; 2020 c. 1, Sch. 5 para. 1(1)
- F790Words in reg. 217(8)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 182; 2020 c. 1, Sch. 5 para. 1(1)
- F791Words in reg. 217A(2)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 183(3); 2020 c. 1, Sch. 5 para. 1(1)
- F792Words in reg. 218 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(2); 2020 c. 1, Sch. 5 para. 1(1)
- F793Words in reg. 218(5)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(3); 2020 c. 1, Sch. 5 para. 1(1)
- F794Words in reg. 218(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(4); 2020 c. 1, Sch. 5 para. 1(1)
- F795Words in reg. 218(5)(d)(ii)(bb) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 184(3); 2020 c. 1, Sch. 5 para. 1(1)
- F796Words in reg. 219(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 185; 2020 c. 1, Sch. 5 para. 1(1)
- F797Words in reg. 219A(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 186(3); 2020 c. 1, Sch. 5 para. 1(1)
- F798Reg. 229(3)(f) substituted (31.12.2020) by S.I. 2019/775, reg. 187 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 141)
- F799Words in reg. 229(3)(f) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 5(c) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 5(c)
- F800Reg. 230(8) substituted (31.12.2020) by S.I. 2019/775, reg. 188 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 142)
- F801Words in reg. 230(8) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 6 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 6
- F802Reg. 231(8) substituted (31.12.2020) by S.I. 2019/775, reg. 189 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 143)
- F803Words in reg. 231(8) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 7 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 7
- F804Reg. 232(8) substituted (31.12.2020) by S.I. 2019/775, reg. 190 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 144)
- F805Reg. 233(7) substituted (31.12.2020) by S.I. 2019/775, reg. 191 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 145)
- F806Words in reg. 233(7) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 8(a) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 8(a)
- F807Reg. 234(9) substituted (31.12.2020) by S.I. 2019/775, reg. 192 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 146)
- F808Words in reg. 234(9) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 9 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 9
- F809Word in reg. 249(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 194(a); 2020 c. 1, Sch. 5 para. 1(1)
- F810Reg. 251(6)(7) inserted (31.12.2020) by S.I. 2019/775, reg. 194A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 149)
- F811Reg. 254(2)(a)-(c) and words substituted for words (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 195; 2020 c. 1, Sch. 5 para. 1(1)
- F812Words in reg. 256A(1) substituted (31.12.2020) by S.I. 2019/775, reg. 197(2)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F813Words in reg. 256A(1) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 197(2)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F814Words in reg. 256A(1) inserted (31.12.2020) by S.I. 2019/775, reg. 197(2)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F815Words in reg. 256A(1) substituted (31.12.2020) by S.I. 2019/775, reg. 197(2)(d)(i)(aa) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F816Words in reg. 256A(1) substituted (31.12.2020) by S.I. 2019/775, reg. 197(2)(d)(i)(bb) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F817Words in reg. 256A(1) substituted (31.12.2020) by S.I. 2019/775, reg. 197(2)(d)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F818Reg. 256B(A1) inserted (31.12.2020) by S.I. 2019/775, reg. 197(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F819Words in reg. 256B(2) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 197(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F820Reg. 256B(3)(3A) substituted for reg. 256B(3) (31.12.2020) by S.I. 2019/775, reg. 197(3)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F821Words in reg. 256B(4) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 197(3)(d) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F822Words in reg. 256B(6) substituted (31.12.2020) by S.I. 2019/775, reg. 197(3)(e) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F823Words in reg. 256B(8)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 197(3)(f) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F824Words in reg. 256B(8)(c) substituted (31.12.2020) by S.I. 2019/775, reg. 197(3)(f) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F825Word in reg. 256C(2)(b)(iv) substituted (31.12.2020) by S.I. 2019/775, reg. 197(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F826Words in reg. 256D(3) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 197(6) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F827Words in reg. 256G(2) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 197(7)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F828Words in reg. 256G(3) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 197(7)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 S.I. 2020/1488, reg. 1, Sch. 2 para. 151)
- F829Words in reg. 256G(3) substituted (31.12.2020) S.I. 2019/775, regs. 1, 197(7)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 S.I. 2020/1488, reg. 1, Sch. 2 para. 151)
- F830Words in reg. 256H(3)(a) omitted (31.12.2020) by S.I. 2019/775, regs. 1, 197(8)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F831Words in reg. 256H(3)(b) substituted (31.12.2020) S.I. 2019/775, regs. 1, 197(8)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F832Reg. 256J(6)(b) and word omitted (31.12.2020) by S.I. 2019/775, regs. 1, 197(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F833Words in reg. 256K(1) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 197(10) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F834Words in reg. 256L(3) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 197(11)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F835Words in reg. 256L(6)(b) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 197(11)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)
- F836Words in reg. 257(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 198(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 152(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F837Reg. 257(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 198(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 152(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F838Reg. 260(1A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 203(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 157(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F839Words in reg. 260(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 203(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 157(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F840Words in reg. 260(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 203(4) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 157(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F841Word in reg. 267 inserted (31.12.2020) by S.I. 2019/775, reg. 206 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 160)
- F842Words in reg. 268(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 207(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F843Words in reg. 268(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 207(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F844Words in reg. 268(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 207(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F845Words in reg. 268(2)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 207(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F846Reg. 268A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 207A (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 162); 2020 c. 1, Sch. 5 para. 1(1)
- F847Words in reg. 269(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 208(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F848Words in reg. 269(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 208(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(b)); ; 2020 c. 1, Sch. 5 para. 1(1)
- F849Words in eg. 269(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 208(2A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F850Words in reg. 269(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 208(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F851Words in reg. 269(2)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 208(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F852Reg. 269A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 208A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 164)
- F853Words in reg. 270(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 209 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 165); 2020 c. 1, Sch. 5 para. 1(1)
- F854Words in reg. 270(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 209 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 165); 2020 c. 1, Sch. 5 para. 1(1)
- F855Words in reg. 271 substituted (31.12.2020) by S.I. 2019/775, reg. 209A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 166)
- F856Reg. 273(2)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 210(2); 2020 c. 1, Sch. 5 para. 1(1)
- F857Reg. 273(3)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 210(3); 2020 c. 1, Sch. 5 para. 1(1)
- F858Words in reg. 277(1) substituted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 10 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 10
- F859Reg. 279 substituted (31.12.2020) by S.I. 2019/775, reg. 211 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 167)
- F860Reg. 279(1)(aa) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 11(a) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350, regs. 1(3), 11(a)
- F861Reg. 279(2)(aa) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 11(b) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 11(b)
- F862Words in reg. 280(1) substituted (31.12.2020) by S.I. 2019/775, reg. 212(a) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 168(b))
- F863Reg. 280(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 212(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 168(c))
- F864Words in reg. 280(4) substituted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 12 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 12
- F865Word in reg. 281(1)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 213(a); 2020 c. 1, Sch. 5 para. 1(1)
- F866Reg. 284A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 213A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 170)
- F867Reg. 293(1) substituted (31.12.2020) by S.I. 2019/775, reg. 214 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 171)
- F868Words in reg. 293(1) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 13 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 13
- F869Reg. 294(5) inserted (31.12.20200 by S.I. 2019/775, reg. 214A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 172)
- F870Reg. 295(2)(d) substituted (31.12.2020) by S.I. 2019/775, reg. 215(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 173)
- F871Reg. 295(4A) inserted (31.12.2020) by S.I. 2019/775, reg. 215(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 173)
- F872Words in reg. 295(2)(d) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 14 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 14
- F873Reg. 298(5)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 215A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 174)
- F874Words in reg. 299(3) substituted (31.12.2020) by S.I. 2019/775, reg. 217 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 176); 2020 c. 1, Sch. 5 para. 1(1)
- F875Reg. 305(3)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 217A(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F876Reg. 305(4)(a)-(c) inserted (31.12.2020) by S.I. 2019/775, reg. 217A(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F877Reg. 306(2)(a)-(c) and words inserted (31.12.2020) by S.I. 2019/775, reg. 217B(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F878Reg. 306(4)(a)(i)-(iii) and words inserted (31.12.2020) by S.I. 2019/775, reg. 217B(b)(i) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F879Words in reg. 306(4) inserted (31.12.2020) by S.I. 2019/775, reg. 217B(b)(ii) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F880Reg. 306(5)(a)-(c) and words inserted (31.12.2020) by S.I. 2019/775, reg. 217B(c) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F881Words in reg. 306(7)(b) inserted (31.12.2020) by S.I. 2019/775, reg. 217B(d) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F882Reg. 306(8)(a)-(c) inserted (31.12.2020) by S.I. 2019/775, reg. 217B(e) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F883Reg. 307(1)(a)(i)-(iii) inserted (31.12.2020) by S.I. 2019/775, reg. 217C(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F884Reg. 307(1)(b)(i)-(iii) inserted (31.12.2020) by S.I. 2019/775, reg. 217C(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F885Reg. 307(2)(a)(i)-(iii) and words substituted for words (31.12.2020) by S.I. 2019/775, reg. 217C(c) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F886Reg. 311(1)(a)(i)-(iii) substituted for words in reg. 311(1)(a) (31.12.2020) by S.I. 2019/775, reg. 217D(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F887Reg. 311(3)(i)(iii) inserted (31.12.2020) by S.I. 2019/775, reg. 217D(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 177)
- F888Word in reg. 321(5)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 218(a); 2020 c. 1, Sch. 5 para. 1(1)
- F889Words in reg. 323(1) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 220(2); 2020 c. 1, Sch. 5 para. 1(1)
- F890Word in reg. 323(3)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 220(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F891Reg. 323(3)(d) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 220(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F892Reg. 323(4A) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 220(4); 2020 c. 1, Sch. 5 para. 1(1)
- F893Word in reg. 327(1)(c)(v) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 221(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F894Reg. 327(2)(g)(iva) inserted (31.12.2020) by S.I. 2019/775, reg. 221(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 180(b))
- F895Words in reg. 331(1) substituted (31.12.2020) by S.I. 2019/775, reg. 222(2)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 181(a))
- F896Words in reg. 331(1)(c) inserted (31.12.2020) by S.I. 2019/775, reg. 222(2)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 181(a))
- F897Reg. 331(4)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 222(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 181(b))
- F898Reg. 331(4)(d)(e) inserted (31.12.2020) by S.I. 2019/775, reg. 222(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 181(b))
- F899Words in reg. 335(6)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 224ZA (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 183)
- F900Words in reg. 336(3)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 224ZB (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 183)
- F901Words in reg. 340(5) substituted (31.12.2020) by S.I. 2019/775, reg. 224ZC (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 183)
- F902Word in reg. 341(4)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 224(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 184)
- F903Words in reg. 345(5) substituted (31.12.2020) by S.I. 2019/775, reg. 226 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 186)
- F904Reg. 346(2)(c)(xixa) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 227(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 187(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F905Reg. 346(2)(d)(ia) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 227(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 187(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F906Word in Sch. 1 para. 1(b) inserted (31.12.2020) by S.I. 2019/775, reg. 8(a)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)
- F907Words in Sch. 1 para. 1(e)(i) substituted (31.12.2020) by S.I. 2019/775, reg. 8(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)
- F908Words in Sch. 1 para. 1(f)(i) substituted (31.12.2020) by S.I. 2019/775, reg. 8(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)
- F909Words in Sch. 1 para. 1(g)(i) substituted (31.12.2020) by S.I. 2019/775, reg. 8(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)
- F910Words in Sch. 1 para. 4 substituted (31.12.2020) by S.I. 2019/775, reg. 8(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)
- F911Sch. 3 para. 1(2)(g) substituted (31.12.2020) by S.I. 2019/775, reg. 18(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(a))
- F912Sch. 3 para. 2(1) substituted (31.12.2020) by S.I. 2019/775, reg. 18(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(b))
- F913Words in Sch. 3 para. 3(2)(d) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F914Sch. 3 para. 3(3)(b)(i)(ia) substituted for Sch. 3 para. 3(3)(b)(i) by S.I. 2019/775, regs. 1, 18(4)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(c)(i))
- F915Words in Sch. 3 para. 3(3)(b)(iv) inserted (31.12.2020) by S.I. 2019/775, reg. 18(4)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(c)(ii))
- F916Sch. 3 para. 3(3)(b)(v) inserted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
- F917Word in Sch. 3 para. 3(3)(d)(i) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
- F918Words in Sch. 3 para. 3(3)(d)(ii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
- F919Sch. 3 para. 3(3)(d)(iii) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(c)(iii) (as amended by S.I. 2020/1488, reg. 1 Sch. 2 para. 12(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F920Sch. 3 para. 3(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(d); 2020 c. 1, Sch. 5 para. 1(1)
- F921Sch. 4 para. 13(b) substituted (31.12.2020) by S.I. 2019/775, reg. 20(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(a))
- F922Sch. 4 para. 14A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 20(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(b))
- F923Sch. 4 para. 15(a)(b) substituted for words in Sch. 4 para. 15 (31.12.2020) by S.I. 2019/775, reg. 20(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(d))
- F924Words in Sch. 4 para. 22(1) substituted (31.12.2020) by S.I. 2019/775, reg. 20(4A) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(d))
- F925Words in Sch. 4 para. 23 substituted (31.12.2020) by S.I. 2019/775, reg. 20(4A) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(d))
- F926Words in Sch. 4 para. 25(m) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 20(5); 2020 c. 1, Sch. 5 para. 1(1)
- F927Words in Sch. 4 para. 33 substituted (31.12.2020) by S.I. 2019/775, reg. 20(6) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(e))
- F928Sch. 4 para. 41A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 20(7) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(f))
- F929Words in Sch. 5 para. 1(2)(e) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 22(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F930Words in Sch. 5 para. 1(2)(e) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 22(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F931Words in Sch. 5 para. 3(11)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 22(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F932Words in Sch. 5 para. 3(11)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 22(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F933Sch. 5 para. 3(11)(b)(iii) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 22(3); 2020 c. 1, Sch. 5 para. 1(1)
- F934Words in Sch. 5 para. 5(2)(d) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 22(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F935Sch. 5 para. 5(2)(c) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 22(4); 2020 c. 1, Sch. 5 para. 1(1)
- F936Sch. 6 para. 3(a)(b) and words substituted for words (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(2); 2020 c. 1, Sch. 5 para. 1(1)
- F937Sch. 6 para. 4(a)(b) and words substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(3); 2020 c. 1, Sch. 5 para. 1(1)
- F938Words in Sch. 6 para. 5 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(4); 2020 c. 1, Sch. 5 para. 1(1)
- F939Sch. 6 paras. 11(a)-(c) and words substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 26(5); 2020 c. 1, Sch. 5 para. 1(1)
- F940Words in Sch. 7 para. 3 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F941Words in Sch. 7 para. 6 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F942Sch. 7 para. 12 renumbered as Sch. 7 para. 12(1) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
- F943Words in Sch. 7 para. 12(1) substituted (31.12.2020) by S.I. 2019/775, reg. 32(3)(a)(ia) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(a))
- F944Words in Sch. 7 para. 12(1)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 32(3)(a)(ii)(zaa) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(b))
- F945Words in Sch. 7 para. 12(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
- F946Words in Sch. 7 para. 12(1)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
- F947Word in Sch. 7 para. 12(1)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(ii)(cc); 2020 c. 1, Sch. 5 para. 1(1)
- F948Words in Sch. 7 para. 12(1)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
- F949Words in Sch. 7 para. 12(1)(b)(iii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
- F950Words in Sch. 7 para. 12(1)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(iii)(cc); 2020 c. 1, Sch. 5 para. 1(1)
- F951Sch. 7 para. 12(1)(c) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)
- F952Sch. 7 para. 12(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(v); 2020 c. 1, Sch. 5 para. 1(1)
- F953Sch. 7 para. 12A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 32(3)(aa) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F954Words in Sch. 7 para. 13(1) inserted (31.12.2020) by S.I. 2019/775, reg. 32(3)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(e))
- F955Words in Sch. 7 para. 13(1)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 32(3)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(e))
- F956Word in Sch. 7 para. 13(2) substituted (31.12.2020) by S.I. 2019/775, reg. 32(3)(b)(iii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(e))
- F957Words in Sch. 7 para. 14(1)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 32(3)(c)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(f)(i))
- F958Sch. 7 para. 14(1)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 32(3)(c)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(f)(ii))
- F959Words in Sch. 7 para. 14(2) inserted (31.12.2020) by S.I. 2019/775, reg. 32(3)(c)(iia) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(f)(iii))
- F960Sch. 7 para. 14(3)-(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)
- F961Words in Sch. 7A para. 13(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 43(2); 2020 c. 1, Sch. 5 para. 1(1)
- F962Words in Sch. 7A para. 15(c) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 43(3); 2020 c. 1, Sch. 5 para. 1(1)
- F963Words in Sch. 8 para. 12(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 50(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(a)(i)); 2020 c. 1, Sch. 5 para. 1(1)
- F964Sch. 8 para. 12(b) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 50(2)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(a)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
- F965Sch. 8 para. 12(e) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 50(2)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(a)(iii)); 2020 c. 1, Sch. 5 para. 1(1)
- F966Sch. 8 para. 18 substituted (31.12.2020) by S.I. 2019/775, regs. 1, 50(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(b))
- F967Words in Sch. 8 para. 19 substituted (31.12.2020) by S.I. 2019/775, reg. 50(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(c))
- F968Words in Sch. 8 para. 20 inserted (31.12.2020) by S.I. 2019/775, reg. 50(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(d))
- F969Sch. 8 para. 21 substituted (31.12.2020) by S.I. 2019/775, reg. 50(6) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(e))
- F970Words in Sch. 8 para. 22 substituted (31.12.2020) by S.I. 2019/775, reg. 50(7) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(f))
- F971Sch. 8 para. 23 substituted (31.12.2020) by S.I. 2019/775, reg. 50(8) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(g))
- F972Words in Sch. 8A para. 6(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 51(a); 2020 c. 1, Sch. 5 para. 1(1)
- F973Sch. 8A para. 6(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 51(b); 2020 c. 1, Sch. 5 para. 1(1)
- F974Words in Sch. 8A para. 6(e) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 51(c); 2020 c. 1, Sch. 5 para. 1(1)
- F975Word in Sch. 10 para. 4(4)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 55; 2020 c. 1, Sch. 5 para. 1(1)
- F976Word in Sch. 11 para. 1(1)(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(2)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
- F977Sch. 11 para. 1(1)(d) and word inserted (31.12.2020) by S.I. 2019/775, reg. 63(2)(a)(ii) (as substituted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(2); 2020 c. 1, Sch. 5 para. 1(1))
- F978Sch. 11 para. 1(1A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F979Sch. 11 para. 1(2) substituted (31.12.2020) by S.I. 2019/775, reg. 63(2)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(a))
- F980Sch. 11 para. 2(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2A) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))
- F981Words in Sch. 11 para. 3(1) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2B)(a) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))
- F982Words in Sch. 11 para. 3(1)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2B)(b) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))
- F983Sch. 11 para. 5(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2C)(a) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))
- F984Words in Sch. 11 para. 5(3) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2C)(b) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))
- F985Word in Sch. 11 para. 10(1)(b) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(2D)(a) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))
- F986Sch. 11 para. 10(1)(d) and word inserted (31.12.2020) by S.I. 2019/775, reg. 63(2D)(b) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))
- F987Words in Sch. 11 para. 12(1) inserted (31.12.2020) by S.I. 2019/775, reg. 63(3)(a) (as substituted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(4); 2020 c. 1, Sch. 5 para. 1(1))
- F988Word in Sch. 11 para. 12(5) inserted (31.12.2020) by S.I. 2019/775, reg. 63(3)(b) (as substituted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(4); 2020 c. 1, Sch. 5 para. 1(1))
- F989Sch. 11 para. 12(4A) inserted (31.12.2020) by S.I. 2019/775, reg. 63(3)(c) (as substituted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(4); 2020 c. 1, Sch. 5 para. 1(1))
- F990Words in Sch. 11 para. 14(a) inserted (31.12.2020) by S.I. 2019/775, reg. 63(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(b))
- F991Word in Sch. 11 para. 15(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(5); 2020 c. 1, Sch. 5 para. 1(1)
- F992Word in Sch. 11 para. 15(3)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(5); 2020 c. 1, Sch. 5 para. 1(1)
- F993Word in Sch. 11 para. 16(2)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(6)(a); 2020 c. 1, Sch. 5 para. 1(1)
- F994Words in Sch. 11 para. 16(5) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(6)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F995Sch. 11 para. 17 substituted (31.12.2020) by S.I. 2019/775, reg. 63(7) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(c))
- F996Words in Sch. 11 para. 24(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(8)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
- F997Sch. 11 para. 24(2) substituted (31.12.2020) by S.I. 2019/775, reg. 63(8)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(d))
- F998Words in Sch. 11 para. 29(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(8)(c); 2020 c. 1, Sch. 5 para. 1(1)
- F999Sch. 11 para. 31 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))
- F1000Sch. 11 para. 34 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))
- F1001Sch. 11 para. 35 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))
- F1002Sch. 11 para. 37 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))
- F1003Sch. 11 para. 38 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(9) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(e))
- F1004Words in Sch. 12 para. 16 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 115(2); 2020 c. 1, Sch. 5 para. 1(1)
- F1005Words in Sch. 12 para. 17 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 115(2); 2020 c. 1, Sch. 5 para. 1(1)
- F1006Words in Sch. 12 para. 21 inserted (31.12.2020) by S.I. 2019/775, reg. 115(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 86)
- F1007Words in Sch. 12 para. 21 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 115(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F1008Symbol in Sch. 12 para. 21 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 115(3)(c); 2020 c. 1, Sch. 5 para. 1(1)
- F1009Words in Sch. 24 para. 7(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 201(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 155(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F1010Words in Sch. 24 para. 15 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 201(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 155(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F1011Words in Sch. 24 para. 16 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 201(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 155(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F1012Words in Sch. 24 para. 23 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 201(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 155(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F1013Words in Sch. 27 para. 8(c)(ii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 204(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(a)); 2020 c. 1, Sch. 5 para. 1(1)
- F1014Words in Sch. 27 para. 11(f) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, reg. 204(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(b)); 2020 c. 1, Sch. 5 para. 1(1)
- F1015Words in Sch. 27 para. 12 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 204(4) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(c)); 2020 c. 1, Sch. 5 para. 1(1)
- F1016Words in Sch. 27 para. 13 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 204(5)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F1017Words in Sch. 27 para. 13 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 204(5)(b); 2020 c. 1, Sch. 5 para. 1(1)
- F1018Symbol in Sch. 27 para. 13 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 204(5)(c); 2020 c. 1, Sch. 5 para. 1(1)
- F1019Words in Sch. 30 para. 1 substituted (31.12.2020) by S.I. 2019/775, reg. 216(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 175)
- F1020Words in Sch. 30 para. 2 substituted (31.12.2020) by S.I. 2019/775, reg. 216(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 175)
- F1021Words in Sch. 30 para. 6 substituted (31.12.2020) by S.I. 2019/775, reg. 216(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 175)
- F1022Words in Sch. 32 para. 3(10) substituted (31.12.2020) by S.I. 2019/775, reg. 224ZD (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 183)
- F1023Sch. 33 para. 1 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178; 2020 c. 1, Sch. 5 para. 1(1)
- F1024Sch. 33 para. 2 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 178; 2020 c. 1, Sch. 5 para. 1(1)
- F1025Words in reg. 8(1) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 3(2)(a) and words in reg. 8(1) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 3(2)(a)
- F1026Reg. 43ZA inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 11
- F1027Regs. 167A, 167B inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 14
- F1028Sch. 4 para. 15A inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 24
- F1029Sch. 4 para. 23ZA inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 25
- F1030Words in reg. 5(4)(b) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 3
- F1031Words in reg. 8(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 4
- F1032Word in reg. 18(1)(b) omitted (1.1.2022) by virtue of The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(a)(i)
- F1033Reg. 18(1)(d) and word inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(a)(ii)
- F1034Words in reg. 18(4) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(b)
- F1035Word in reg. 18(6)(a) omitted (1.1.2022) by virtue of The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(c)(i)
- F1036Reg. 18(6)(c) and word inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(c)(ii)
- F1037Words in reg. 19(1)(a)(i) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 6
- F1038Word in reg. 26(5)(a)(i) omitted (1.1.2022) by virtue of The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 7(a)
- F1039Reg. 26(5)(a)(iii) and word inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 7(b)
- F1040Words in reg. 37(6)(b)(i) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 8
- F1041Reg. 39(8) substituted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 9
- F1042Words in reg. 42(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 10(a)(i)
- F1043Words in reg. 42(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 10(a)(ii)
- F1044Words in reg. 45(2)(b)(ii) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 12
- F1045Words in reg. 187(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 15
- F1046Words in reg. 188(1) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 16
- F1047Words in reg. 229(3)(f)(i) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 17
- F1048Words in reg. 230(8)(a) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 18
- F1049Words in reg. 231(8)(a) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 19
- F1050Words in reg. 233(7)(a) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 20
- F1051Words in reg. 234(9)(a) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 21
- F1052Reg. 346(2)(c)(xxviiiaza) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 23
- F1053Words in reg. A81 inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 13
- F1054Sch. 7 para. 12A(2) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 26
- F1055Reg. 229(4) omitted (31.3.2022) by virtue of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022 (S.I. 2022/350), regs. 1(2), 5
- F1056Reg. 233(9) omitted (31.3.2022) by virtue of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022 (S.I. 2022/350), regs. 1(2), 6
- F1057Reg. 235(8) omitted (31.3.2022) by virtue of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022 (S.I. 2022/350), regs. 1(2), 7
- F1058Sch. 34 para. 78 revoked (1.4.2022) by The Medicines and Healthcare Products Regulatory Agency Trading Fund (Revocation) Order 2022 (S.I. 2022/90), art. 1, Sch.
- F1059Regs. 167C-167H inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 8 (with reg. 19)
- F1060Sch. 4 para. 14B inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(2) (with reg. 19)
- F1061Sch. 4 para. 23B inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(4) (with reg. 19)
- F1062Sch. 4 para. 33A inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(5) (with reg. 19)
- F1063Words in reg. 6(1) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 3 (with reg. 19)
- F1064Words in reg. 8(1) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 4 (with reg. 19)
- F1065Word in reg. 37(6)(a) omitted (15.4.2022) by virtue of The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 5(2)(a) (with reg. 19)
- F1066Reg. 37(6)(aa) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 5(2)(b) (with reg. 19)
- F1067Words in reg. 37(10) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 5(3) (with reg. 19)
- F1068Reg. 41(12) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 6 (with reg. 19)
- F1069Reg. 43(6)(aa) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 7 (with reg. 19)
- F1070Words in reg. 175(3)(a) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 9(2) (with reg. 19)
- F1071Words in reg. 175(3)(b) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 9(3) (with reg. 19)
- F1072Words in reg. 175(3)(c) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 9(4) (with reg. 19)
- F1073Reg. 177(1B) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 10 (with reg. 19)
- F1074Words in reg. 346(2)(c)(xxviiiaza) substituted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 11 (with reg. 19)
- F1075Word in Sch. 1 para. 1(g) omitted (15.4.2022) by virtue of The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(2)(a) (with reg. 19)
- F1076Word in Sch. 1 para. 1(h) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(2)(b) (with reg. 19)
- F1077Sch. 1 para. 1(i) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(2)(c) (with reg. 19)
- F1078Word in Sch. 1 para. 3(c) omitted (15.4.2022) by virtue of The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(3)(a) (with reg. 19)
- F1079Word in Sch. 1 para. 3(d) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(3)(b) (with reg. 19)
- F1080Sch. 1 para. 3(e) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(3)(c) (with reg. 19)
- F1081Sch. 3 para. 3(3)(d)(ia) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 13 (with reg. 19)
- F1082Words in Sch. 4 para. 22(5) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(3)(a) (with reg. 19)
- F1083Words in Sch. 4 para. 22(7) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(3)(b) (with reg. 19)
- F1084Words in Sch. 4 para. 22(8) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(3)(c) (with reg. 19)
- F1085Words in Sch. 4 para. 22(9) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(3)(d) (with reg. 19)
- F1086Words in Sch. 4 para. 37 inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(6) (with reg. 19)
- F1087Words in Sch. 4 para. 39 inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(7) (with reg. 19)
- F1088Words in Sch. 4 para. 40 inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(8) (with reg. 19)
- F1089Words in Sch. 4 para. 41 inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 14(9) (with reg. 19)
- F1090Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1(1)(3) (with Sch. para. 1(2))
- F1091Words in reg. 213(1) omitted (1.7.2022) by virtue of The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), regs. 1(2), 57(2)(a)
- F1092Words in reg. 213(1) inserted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), regs. 1(2), 57(2)(b)
- F1093Words in reg. 219(5) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 44 (with reg. 3)
- F1094Reg. 345A inserted (17.5.2023) by The Human Medicines (Amendment) Regulations 2023 (S.I. 2023/437), regs. 1(1), 5
- F1095Words in reg. 17(2) substituted (17.5.2023) by The Human Medicines (Amendment) Regulations 2023 (S.I. 2023/437), regs. 1(1), 3(2)
- F1096Reg. 17(9) inserted (17.5.2023) by The Human Medicines (Amendment) Regulations 2023 (S.I. 2023/437), regs. 1(1), 3(3)
- F1097Reg. 49(3)(a) substituted (17.5.2023) by The Human Medicines (Amendment) Regulations 2023 (S.I. 2023/437), regs. 1(1), 4(a)
- F1098Words in reg. 49(3)(c) substituted (17.5.2023) by The Human Medicines (Amendment) Regulations 2023 (S.I. 2023/437), regs. 1(1), 4(c)
- F1099Regs. 217B, 217C inserted (E.W.S.) (11.10.2023) by The Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023 (S.I. 2023/1015), regs. 1(2), 2(2)
- F1100Reg. 58(6) omitted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(3)); 2020 c. 1, Sch. 5 para. 1(1)
- F1101Reg. 58(7) omitted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(3)); 2020 c. 1, Sch. 5 para. 1(1)
- F1102Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
- F1103Reg. 217BA inserted (N.I.) (4.6.2024) by The Human Medicines (Amendment Relating to Original Pack Dispensing) Regulations (Northern Ireland) 2024 (S.R. 2024/125), regs. 1(2), 2(2)
- F1104Reg. 217CA inserted (N.I.) (4.6.2024) by The Human Medicines (Amendment Relating to Original Pack Dispensing) Regulations (Northern Ireland) 2024 (S.R. 2024/125), regs. 1(2), 2(3)
- F1105Words in Sch. 16 Pt. 4 inserted (26.6.2024) by The Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024 (S.I. 2024/729), regs. 1(2), 4
- F1106Words in Sch. 17 Pt. 4 inserted (26.6.2024) by The Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024 (S.I. 2024/729), regs. 1(2), 5(4)
- F1107Words in Sch. 17 Pt. 3 inserted (26.6.2024) by The Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024 (S.I. 2024/729), regs. 1(2), 5(3)
- F1108Words in Sch. 17 Pt. 2 inserted (26.6.2024) by The Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024 (S.I. 2024/729), regs. 1(2), 5(2)
- F1109Words in reg. 213(1) inserted (26.6.2024) by The Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024 (S.I. 2024/729), regs. 1(2), 3
- F1110Reg. 237A inserted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 7
- F1111Words in Sch. 16 Pt. 2 Table substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 10(a)
- F1112Words in Sch. 16 Pt. 2 Table substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 10(b)
- F1113Words in Sch. 17 Pt. 2 Table omitted (2.12.2024) by virtue of The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 11(2)
- F1114Words in Sch. 17 Pt. 5 Table omitted (2.12.2024) by virtue of The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 11(3)
- F1115Words in Sch. 19 substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 12
- F1116Words in Sch. 22 substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 13
- F1117Words in reg. 8(1) inserted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 3
- F1118Words in reg. 213(1) substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 4(a)
- F1119Words in reg. 213(1) omitted (2.12.2024) by virtue of The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 4(b)
- F1120Words in reg. 213(1) inserted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 4(c)
- F1121Reg. 229(1)(db) substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 5
- F1122Reg. 233(1)(a)(ivd) substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 6
- F1123Reg. 250(4B) inserted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 8
- F1124Words in reg. 346(2)(d)(ivza) substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 9(a)
- F1125Words in reg. 346(2)(d)(ivb) substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 9(c)
- F1126Word in reg. 8(1) omitted (13.12.2024) by virtue of The Anaesthesia Associates and Physician Associates Order 2024 (S.I. 2024/374), art. 1(3), Sch. 5 para. 19(a)
- F1127Words in reg. 8(1) inserted (13.12.2024) by The Anaesthesia Associates and Physician Associates Order 2024 (S.I. 2024/374), art. 1(3), Sch. 5 para. 19(b)
- F1128Regs. 81-88 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 65
- F1129Words in reg. 50I heading omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 33(a)
- F1130Words in reg. 78B heading substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(a)
- F1131Word in reg. A81 heading substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 64
- F1132Words in reg. 65C heading inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 53
- F1133Regs. 257AA, 257AB inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 111 (with reg. 1(2))
- F1134Reg. 347B inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 133
- F1135Words in Sch. 17 Pt. 1 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 141(a)
- F1136Words in Sch. 17 Pt. 4 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 141(b)
- F1137Sch. 24 para. 18B inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(e)
- F1138Words in Sch. 24 Pt. 4 heading omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(g)
- F1139Words in Sch. 24 Pt. 5 heading omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(h)
- F1140Words in Sch. 27 Pt. 3 heading omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 143(c)
- F1141Sch. 33B inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 146
- F1142Words in reg. 2A(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 3
- F1143Words in reg. 2A(10) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 3
- F1144Reg. 3(12)(d)(ia) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 4(a)
- F1145Reg. 3(15)(aa) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 4(b)
- F1146Reg. 4(4)(d)(ia) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 5
- F1147Reg. 5(1)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(a)(ii)
- F1148Reg. 5(3)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(b)(i)
- F1149Words in reg. 5(3)(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(b)(ii)
- F1150Reg. 5(5)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(c)(i)
- F1151Words in reg. 5(5)(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(c)(ii)
- F1152Reg. 5(1)(a): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(a)(i)
- F1153Words in reg. 8(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(i)
- F1154Words in reg. 8(1) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(ii)
- F1155Words in reg. 8(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(iii)
- F1156Words in reg. 8(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(iv)
- F1157Words in reg. 8(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(v)
- F1158Words in reg. 8(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(vi)
- F1159Words in reg. 8(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(vii)
- F1160Words in reg. 8(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(viii)
- F1161Words in reg. 8(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(ix)
- F1162Words in reg. 8(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(x)
- F1163Words in reg. 8(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(xi)
- F1164Words in reg. 8(1) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(xii)
- F1165Words in reg. 8(1) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(xiii)
- F1166Words in reg. 8(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(a)(xiv)
- F1167Words in reg. 8(9) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 7(b)
- F1168Word in reg. 17(9) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 10(c)
- F1169Reg. 17(4)(b) and word omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 10(a)
- F1170Reg. 17(7)(b) and word omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 10(b)
- F1171Reg. 17(9)(e) and word omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 10(d)
- F1172Reg. 18(7) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 11(b)
- F1173Words in reg. 18(6)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 11(a)
- F1174Words in reg. 19(1)(a)(ii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 12
- F1175Words in reg. 31(3)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 13(a)
- F1176Words in reg. 31(5)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 13(b)
- F1177Words in reg. 31(5)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 13(b)
- F1178Reg. 36(4)-(7) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 14
- F1179Words in reg. 37(5)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 15(a)
- F1180Words in reg. 37(5)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 15(b)
- F1181Reg. 39(8)(a): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 16(a)
- F1182Reg. 39(8)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 16(b)
- F1183Reg. 42(4) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 17
- F1184Reg. 42(5) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 17
- F1185Reg. 42(6) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 17
- F1186Reg. 43(10) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 18(d)
- F1187Words in reg. 43(7)(c)(vii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 18(c)
- F1188Reg. 43(11) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 18(e)
- F1189Words in reg. 43(13) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 18(f)
- F1190Words in reg. 43(5)(a)(ii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 18(a)
- F1191Words in reg. 43(7)(b)(ii)(bb) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 18(b)
- F1192Reg. 43A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 19
- F1193Reg. 44(6)(e) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 20(a)(ii)
- F1194Words in reg. 44(8) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 20(b)
- F1195Reg. 44(6)(d): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 20(a)(i)
- F1196Reg. 45A(1A)(a)(i) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 21
- F1197Reg. 45E(3)(d)(iii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 22
- F1198Reg. 45F(1)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 23
- F1199Reg. 46(2)(aa) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 24(a)
- F1200Reg. 46(6)(aa) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 24(b)
- F1201Words in reg. 48(2) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(2)(a)
- F1202Word in reg. 48(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(2)(b)
- F1203Words in reg. 48(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(2)(c)(i)
- F1204Words in reg. 48(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(2)(c)(ii)
- F1205Words in reg. 48(2) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(2)(d)(i)
- F1206Reg. 48(2): comma substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(2)(d)(ii)(aa)
- F1207Words in reg. 48(2) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(2)(d)(ii)(bb)
- F1208Reg. 48(9) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(4)
- F1209Words in reg. 48(7) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(3)
- F1210Reg. 48(8) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 25(4)
- F1211Reg. 49(1ZA)-(1ZD) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 26(a)
- F1212Reg. 49(3ZA) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 26(d)
- F1213Words in reg. 49(1A) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 26(b)(i)
- F1214Words in reg. 49(3)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 26(c)(i)
- F1215Reg. 49(3)(b)(ii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 26(c)(ii)(bb)
- F1216Words in reg. 49(3)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 26(c)(ii)(aa)
- F1217Reg. 49(1A)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 26(b)(ii)
- F1218Reg. 49(9)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 26(e)
- F1219Words in reg. 50(5A) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 27(b)(i)
- F1220Words in reg. 50(5A) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 27(b)(ii)
- F1221Words in reg. 50(4)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 27(a)(i)
- F1222Words in reg. 50(4)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 27(a)(ii)
- F1223Reg. 50(6)(aa) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 27(c)
- F1224Reg. 50(6)(ba) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 27(c)
- F1225Reg. 50(6)(ca) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 27(c)
- F1226Words in reg. 50A(1)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 28(a)
- F1227Words in reg. 50A(7) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 28(b)
- F1228Words in reg. 50A(8) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 28(c)
- F1229Words in reg. 50E(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 29(a)
- F1230Words in reg. 50E(5) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 29(b)
- F1231Words in reg. 50F(1)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 30(a)
- F1232Words in reg. 50F(1)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 30(b)
- F1233Words in reg. 50G(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 31(b)
- F1234Reg. 50G(1)(a): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 31(a)(i)
- F1235Reg. 50G(1)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 31(a)(ii)
- F1236Words in reg. 50H(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 32
- F1237Words in reg. 50H(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 32
- F1238Words in reg. 50I(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 33(b)
- F1239Words in reg. 51(2) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 34(a)
- F1240Reg. 51(3) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 34(b)
- F1241Reg. 51(4) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 34(b)
- F1242Reg. 51A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 35
- F1243Reg. 51B substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 36
- F1244Words in reg. 52(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 37
- F1245Reg. 52A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 38
- F1246Reg. 52B substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 39
- F1247Words in reg. 53(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 40
- F1248Reg. 53A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 41
- F1249Reg. 53B substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 42
- F1250Reg. 55(1)(b)(ii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 43(a)(i)
- F1251Reg. 55(1)(b)(iii)(bb) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 43(a)(ii)
- F1252Reg. 55(3) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 43(b)
- F1253Words in reg. 58(8) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 44
- F1254Words in reg. 58A(4)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 45(b)
- F1255Words in reg. 58A(8) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 45(c)
- F1256Reg. 58A(3)(a): comma substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 45(a)(i) (with savings in Regulation (EC) No 469/2009, Annex 3 para. 5 (as inserted by S.I. 2024/1075, regs. 1(1), 10))
- F1257Reg. 58A(3)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 45(a)(ii) (with savings in Regulation (EC) No 469/2009, Annex 3 para. 5 (as inserted by S.I. 2024/1075, regs. 1(1), 10))
- F1258Words in reg. 58F(1)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 46
- F1259Words in reg. 59(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 47(a)
- F1260Words in reg. 59(3A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 47(b)
- F1261Words in reg. 59(3B) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 47(c)(i)
- F1262Words in reg. 59(3B) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 47(c)(ii)
- F1263Words in reg. 59(5) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 47(d)
- F1264Words in reg. 60(9) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 48
- F1265Reg. 60A(10A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 49(e)
- F1266Words in reg. 60A(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 49(a)
- F1267Words in reg. 60A(5) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 49(b)
- F1268Words in reg. 60A(9)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 49(c)
- F1269Words in reg. 60A(9)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 49(c)
- F1270Words in reg. 60A(10) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 49(d)
- F1271Reg. 60B omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 50
- F1272Words in reg. 61(6) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 51(b)
- F1273Reg. 61(7) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 51(d)
- F1274Words in reg. 61(13) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 51(f)
- F1275Words in reg. 61(4)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 51(a)
- F1276Words in reg. 61(6A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 51(c)
- F1277Reg. 61(7A) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 51(e)
- F1278Words in reg. 64(4)(d)(i) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 52(a)
- F1279Words in reg. 64(4)(d)(ii) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 52(b)
- F1280Words in reg. 65C(1) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 53
- F1281Words in reg. 65C(3) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 53
- F1282Reg. 66(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 54(a)
- F1283Words in reg. 66(2)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 54(b)(i)
- F1284Reg. 66(2)(b)(ii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 54(b)(ii)
- F1285Reg. 66(2)(c) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 54(c)
- F1286Words in reg. 67(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 55
- F1287Words in reg. 67(2) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 55
- F1288Reg. 68(11H)-(A12) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 56(b)
- F1289Reg. 68(7)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 56(a)(i)
- F1290Reg. 68(7)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 56(a)(ii)
- F1291Reg. 71(1)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 57
- F1292Words in reg. 72(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 58
- F1293Words in reg. 73(5C) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 59
- F1294Words in reg. 76(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 60(a)
- F1295Words in reg. 76(2)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 60(b)
- F1296Words in reg. 78B(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(b)(i)
- F1297Words in reg. 78B(1)(c) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(b)(ii)
- F1298Words in reg. 78B(1)(d) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(b)(iii)
- F1299Words in reg. 78B(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 61(c)
- F1300Words in reg. 79(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 62
- F1301Words in reg. 79(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 62
- F1302Words in reg. 80(d) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 63(d)
- F1303Words in reg. 80(a)(ii) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 63(a)
- F1304Words in reg. 80(b)(i) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 63(b)
- F1305Words in reg. 80(b)(ii) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 63(c)
- F1306Reg. 94A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 66
- F1307Word in reg. 95 inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 67(a)
- F1308Reg. 95(c) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 67(b)
- F1309Reg. 95(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 67(b)
- F1310Word in reg. 101(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 68
- F1311Words in reg. 159(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 69
- F1312Words in reg. 164(2)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 70
- F1313Words in reg. 164(2)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 70
- F1314Words in reg. 169(9)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 71
- F1315Words in reg. 171(2)(c) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 72
- F1316Words in reg. 173(c) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 73
- F1317Reg. 177(4) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 74(b)
- F1318Words in reg. 177(5) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 74(c)
- F1319Words in reg. 177(1A) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 74(a)
- F1320Words in reg. 180(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 75(a)
- F1321Words in reg. 180(1A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 75(b)
- F1322Words in reg. 181(1) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 76
- F1323Words in reg. 184(3) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 77
- F1324Reg. 186(1)(d)(ii) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 78(a)
- F1325Reg. 186(1)(e)(ii) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 78(b)
- F1326Words in reg. 188(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 79(b)
- F1327Words in reg. 188(1A) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 79(a)(i)
- F1328Words in reg. 188(4A) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 79(c)
- F1329Words in reg. 188(1A)(a) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 79(a)(ii)
- F1330Words in reg. 188(1A)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 79(a)(ii)
- F1331Words in reg. 189(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 80(a)
- F1332Words in reg. 189(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 80(b)
- F1333Words in reg. 190(1)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 81
- F1334Words in reg. 191(1) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(a)(i)
- F1335Words in reg. 191(1) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(a)(ii)
- F1336Words in reg. 191(7) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(c)(i)
- F1337Words in reg. 191(7) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(c)(ii)
- F1338Words in reg. 191(4A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(b)
- F1339Words in reg. 191(8A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(d)
- F1340Words in reg. 191(10)(c)(i) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(e)(iii)(aa)
- F1341Words in reg. 191(10)(c)(ii) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(e)(iii)(bb)
- F1342Words in reg. 191(10)(b)(i) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(e)(i)
- F1343Words in reg. 191(10)(b)(ii) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(e)(ii)(aa)
- F1344Words in reg. 191(10)(b)(ii) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 82(e)(ii)(bb)
- F1345Words in reg. 192(3) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 83(a)(i)
- F1346Words in reg. 192(3) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 83(a)(ii)
- F1347Words in reg. 192(9) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 83(b)
- F1348Words in reg. 193(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 84(b)
- F1349Words in reg. 193(2A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 84(c)
- F1350Words in reg. 193(4A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 84(d)
- F1351Words in reg. 193(1)(a)(i) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 84(a)(i)
- F1352Words in reg. 193(1)(a)(ii) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 84(a)(ii)
- F1353Words in reg. 193(1)(b)(i) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 84(a)(iii)
- F1354Words in reg. 193(1)(b)(ii) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 84(a)(iv)
- F1355Words in reg. 194(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 85
- F1356Words in reg. 195(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 86(a)
- F1357Words in reg. 195(1A) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 86(b)
- F1358Words in reg. 196(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 87
- F1359Words in reg. 197(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 88
- F1360Words in reg. 198(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 89(a)
- F1361Words in reg. 198(2)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 89(b)
- F1362Words in reg. 199(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 90(a)(i)
- F1363Words in reg. 199(2)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 90(a)(ii)
- F1364Words in reg. 199(3)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 90(b)
- F1365Words in reg. 200(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 91(a)(i)
- F1366Words in reg. 200(2)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 91(a)(ii)
- F1367Words in reg. 200(3)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 91(b)
- F1368Words in reg. 201(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 92(a)(i)
- F1369Words in reg. 201(2)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 92(a)(ii)
- F1370Words in reg. 201(3)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 92(b)
- F1371Words in reg. 202(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 93
- F1372Words in reg. 204(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 94
- F1373Words in reg. 205(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 95(a)
- F1374Words in reg. 205(2) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 95(b)
- F1375Words in reg. 205A(1) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 96(a)
- F1376Words in reg. 205A(2) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 96(b)
- F1377Words in reg. 206(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 97
- F1378Reg. 210 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 98
- F1379Words in reg. 210A(1)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 99(a)(i)
- F1380Words in reg. 210A(1)(aa) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 99(a)(ii)
- F1381Word in reg. 210A(2A) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 99(b)
- F1382Words in reg. 211 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 100
- F1383Words in reg. 229(3)(f)(i) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 101
- F1384Words in reg. 230(8)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 102
- F1385Words in reg. 231(8)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 103
- F1386Words in reg. 233(7)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 104
- F1387Words in reg. 234(9)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 105
- F1388Reg. 249(2)(aa) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 107
- F1389Reg. 251(7)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 108(a)
- F1390Words in reg. 251(7)(c) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 108(b)
- F1391Reg. 255A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 109(a)
- F1392Reg. 255B omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 109(b)
- F1393Reg. 255C omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 109(c)
- F1394Reg. 257(9) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 110(c) (with reg. 1(2))
- F1395Words in reg. 257(6) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 110(a) (with reg. 1(2))
- F1396Words in reg. 257(8) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 110(b) (with reg. 1(2))
- F1397Reg. 257A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 112
- F1398Reg. 257B omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 113
- F1399Words in reg. 257C(1)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 114
- F1400Reg. 257E(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 115
- F1401Words in reg. 259(2) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 116
- F1402Words in reg. 260(1A) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 117(a)
- F1403Words in reg. 260(2) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 117(b)
- F1404Words in reg. 260(3) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 117(c)
- F1405Words in reg. 268A(2)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 118
- F1406Words in reg. 269A(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 119(a)
- F1407Words in reg. 269A(2)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 119(b)
- F1408Words in reg. 270(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 120(a)
- F1409Words in reg. 270(2) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 120(b)
- F1410Word in reg. 279(2)(c) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 121(a)
- F1411Reg. 279(2)(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 121(b)
- F1412Words in reg. 280(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 122
- F1413Word in reg. 281(1)(c) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 123(a)
- F1414Reg. 281(1)(e) and word omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 123(b)
- F1415Words in reg. 293(1)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 124
- F1416Words in reg. 295(2)(d)(ii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 125
- F1417Reg. 346(2)(c)(xviia) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)
- F1418Reg. 346(2)(c)(iia) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)
- F1419Reg. 346(2)(c)(iiia) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)
- F1420Reg. 346(2)(c)(iva) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)
- F1421Reg. 346(2)(c)(xxviiij) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)
- F1422Reg. 346(2)(c)(xxviiii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)
- F1423Word in reg. 346(2)(c)(iv) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(a)
- F1424Reg. 346(2)(c)(xviii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)
- F1425Reg. 346(2)(c)(xix) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)
- F1426Words in reg. 299(3) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 126
- F1427Reg. 321(5)(ca) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 127
- F1428Reg. 327(2)(h) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 128(b)
- F1429Reg. 327(4A) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 128(c)
- F1430Words in reg. 327(5)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 128(d)(i)
- F1431Words in reg. 327(5)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 128(d)(ii)
- F1432Reg. 327(1)(c)(va) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 128(a)
- F1433Words in reg. 331(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 129(a)
- F1434Words in reg. 331(1)(c) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 129(b)
- F1435Reg. 341(4)(aa) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 130
- F1436Words in reg. 345(5) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 131
- F1437Word in reg. A81 substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 64
- F1438Words in reg. B17(2)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 8
- F1439Words in reg. C17(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 9
- F1440Words in Sch. 1 para. 1(e)(i) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 134(a)(i)
- F1441Words in Sch. 1 para. 1(f)(i) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 134(a)(ii)
- F1442Words in Sch. 1 para. 1(g)(i) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 134(a)(iii)
- F1443Words in Sch. 1 para. 4 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 134(b)
- F1444Sch. 7 para. 12A(1)(c) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 135(b)
- F1445Sch. 7 para. 12A(1)(b): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 135(a)
- F1446Sch. 7A para. 15(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 136
- F1447Sch. 8 para. 18(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 137(a)(i)
- F1448Words in Sch. 8 para. 18(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 137(a)(ii)
- F1449Words in Sch. 8 para. 23(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 137(b)(i)
- F1450Words in Sch. 8 para. 23(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 137(b)(ii)
- F1451Words in Sch. 8 para. 25A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 137(c)
- F1452Words in Sch. 8C para. 1 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 138(a)
- F1453Words in Sch. 8C para. 2 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 138(b)
- F1454Words in Sch. 8C para. 3 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 138(c)
- F1455Words in Sch. 9A para. 1 heading substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(a)
- F1456Words in Sch. 9A para. 1(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(b)
- F1457Words in Sch. 9A para. 1(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(b)
- F1458Words in Sch. 9A para. 1(2)(c) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(b)
- F1459Words in Sch. 9A para. 2(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(c)
- F1460Words in Sch. 9A para. 2(2)(c) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(c)
- F1461Words in Sch. 9A para. 2(2)(d) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(c)
- F1462Words in Sch. 9A para. 2(2)(g) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(c)
- F1463Words in Sch. 9A para. 2(2)(h) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(c)
- F1464Words in Sch. 9A para. 3(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(d)
- F1465Words in Sch. 9A para. 3(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 139(d)
- F1466Words in Sch. 12A para. 1(3) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 140(a)
- F1467Words in Sch. 12A para. 12(5) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 140(b)
- F1468Words in Sch. 12A para. 16(3) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 140(c) (with reg. 1(2))
- F1469Words in Sch. 12A para. 22(1)(d) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 140(d) (with reg. 1(2))
- F1470Words in Sch. 12A para. 30(g) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 140(e)
- F1471Words in Sch. 24 para. 7(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(a)
- F1472Words in Sch. 24 para. 15 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(b)
- F1473Words in Sch. 24 para. 16 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(c)
- F1474Sch. 24 para. 18A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(d)
- F1475Words in Sch. 24 para. 23 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(f)
- F1476Words in Sch. 27 para. 8(c)(ii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 143(a)
- F1477Words in Sch. 27 para. 11(f) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 143(b)
- F1478Words in Sch. 30 para. 1 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 144(a)
- F1479Words in Sch. 30 para. 2 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 144(b)
- F1480Words in Sch. 30 para. 6 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 144(c)
- F1481Sch. 33A para. 29A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 145
- F1482Words in reg. 259(2) substituted (31.12.2020) by S.I. 2019/775, reg. 202 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 156)
- F1483Words in reg. 346(2)(d)(iva) omitted (2.12.2024) by virtue of The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 9(b)
- F1484Words in reg. 346(2)(d)(iva) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 7 and words in reg. 346(2)(d)(iva) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 7
- F1485Words in reg. 346(2)(d)(iva) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(b)(i) and words in reg. 346(2)(d)(iva) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(b)(i)
- F1486Regs. 17A, 17B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 6
- F1487Reg. 27A inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 10
- F1488Regs. 29A, 29B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 12
- F1489Regs. 37A, 37B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 14
- F1490Reg. 50K inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 17
- F1491Regs. 74A, 74B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 18
- F1492Regs. 170A, 170B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 23
- F1493Reg. 257CA inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 31
- F1494Sch. 3 paras. 1A, 1B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(4)
- F1495Sch. 4 Pts. 1A, 1B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 35
- F1496Sch. 7 para. 12B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 36
- F1497Words in reg. 17(1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 5(2)
- F1498Reg. 17(1A) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 5(3)
- F1499Reg. 17(10)(11) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 5(4)
- F1500Sch. 24 Pts. 6, 7 inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 38
- F1501Words in reg. 20(2) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 7
- F1502Reg. 22(1A)(1B) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 8
- F1503Reg. 26(2)(d)(e) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 9(b)
- F1504Word in reg. 26(2)(b) omitted (23.7.2025) by virtue of The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 9(a)
- F1505Reg. 29(2A)-(2F) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 11
- F1506Word in reg. 37(6)(aa) omitted (23.7.2025) by virtue of The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 13(2)(a)
- F1507Reg. 37(6)(ab)(ac) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 13(2)(b)
- F1508Words in reg. 37(8) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 13(3)
- F1509Reg. 39(5A)-(5E) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(3)
- F1510Words in reg. 39(4) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(2)
- F1511Words in reg. 39(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(2)
- F1512Words in reg. 50(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 16(2)
- F1513Reg. 50(5AA)(5AB) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 16(3)
- F1514Reg. 167(6A)(6B) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 19(3)
- F1515Words in reg. 167(7) omitted (23.7.2025) by virtue of The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 19(4)
- F1516Words in reg. 167(6) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 19(2)
- F1517Words in reg. 167G(1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 20(2)(a)
- F1518Words in reg. 167G(1)(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 20(2)(b)
- F1519Reg. 167G(1A)(1B) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 20(3)
- F1520Reg. 169(A1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 21
- F1521Reg. 170(A1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 22
- F1522Reg. 171(A1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 24
- F1523Words in reg. 178(e) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 26
- F1524Reg. 188(1B)(1C) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(4)
- F1525Words in reg. 188(1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(2)(a)
- F1526Reg. 188(1)(ca) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(2)(b)
- F1527Words in reg. 188(1A) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(3)(a)
- F1528Reg. 188(1A)(ba) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(3)(b)
- F1529Reg. 202A(2)(d)(e) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 28
- F1530Reg. 257(10) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 29
- F1531Reg. 258(9) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 32
- F1532Words in reg. 8(1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 4
- F1533Reg. 346(2)(c)(ai)(bi) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(a)
- F1534Reg. 257C(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 30
- F1535Reg. 346(2)(c)(iiza)-(iizc) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(b)
- F1536Reg. 346(2)(c)(iiiza)(iiizb) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(c)
- F1537Reg. 346(2)(c)(va) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(d)
- F1538Reg. 346(2)(c)(xivb)(xivc) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(e)
- F1539Reg. 346(2)(c)(xxviiiazb)(xxviiiazc) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(f)
- F1540Reg. 346(2)(c)(xxviiik) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(g)
- F1541Words in Sch. 8 para. 9A inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 37(2)
- F1542Sch. 8 para. 16 substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 37(3)
- F1543Words in Sch. 3 para. 1(2)(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(2)(a)
- F1544Sch. 3 para. 1(2)(ca)(cb) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(2)(b)
- F1545Words in Sch. 3 para. 1(2)(d) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(2)(c)
- F1546Words in reg. 175(3)(a) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 25(2)(a)
- F1547Words in reg. 175(3)(b) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 25(2)(b)
- F1548Words in reg. 175(3)(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 25(2)(c)
- F1549Sch. 3 para. 1(3)(ba) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(3)
- F1550Regs. 222A, 222B inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 9
- F1551Sch. 25 para. 6A inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 11
- F1552Sch. 26 para. 4A inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 12(2)
- F1553Sch. 26 para. 10A inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 12(3)
- F1554Reg. 3(5A) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(3)
- F1555Reg. 3(11A) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(5)
- F1556Word in reg. 3(2) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(2)
- F1557Word in reg. 3(10) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(4)
- F1558Words in reg. 3(12)(b) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(6)
- F1559Words in reg. 8(1) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 5(2)(a)
- F1560Words in reg. 8(1) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 5(2)(b)
- F1561Reg. 8(3) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 5(3)
- F1562Reg. 18(5A) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 6(3)
- F1563Words in reg. 18(4) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 6(2)
- F1564Words in reg. 221(1) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 8(2)
- F1565Words in reg. 221(2) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 8(3)
- F1566Words in reg. 221(3)(a) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 8(4)
- F1567Words in reg. 274(2)(b) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 10
- F1568Words in reg. 220(2)(b) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 7
- F1569Reg. 220B inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(a), 7(4)
- F1570Words in reg. 62(5) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(3) (with reg. 12(19)(a))
- F1571Words in reg. 106(2) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(4) (with reg. 12(19)(a))
- F1572Words in reg. 131(2) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(5) (with reg. 12(19)(a))
- F1573Reg. 217B(2)(b) substituted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(7) (with reg. 12(19)(b))
- F1574Words in reg. 217BA(2)(b) substituted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(8)
- F1575Reg. 217C(2)(a) substituted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(9)(a) (with reg. 12(19)(c))
- F1576Words in reg. 217C(2)(b) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(9)(b)
- F1577Words in reg. 217CA(2)(a) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(10)
- F1578Reg. 220(2)(c) substituted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(a), 7(2) (with art. 7(5))
- F1579Words in reg. 248(2)(b) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(12) (with reg. 12(19)(a))
- F1580Words in reg. 250(3) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(13) (with reg. 12(19)(a))
- F1581Words in reg. 255(1)(c) omitted (7.1.2026) by virtue of The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(14)
- F1582Reg. 346(2)(c)(xxviiiezb) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(16)(b)
- F1583Reg. 235A inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 9
- F1584Words in Sch. 16 heading inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 13(a)
- F1585Words in Sch. 16 Pt. 1 heading inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 13(b)
- F1586Word in Sch. 17 Pt. 2 Table substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(2)(a)
- F1587Words in Sch. 17 Pt. 2 Table omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(2)(b)
- F1588Word in Sch. 17 Pt. 3 Table substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(3)(a)
- F1589Words in Sch. 17 Pt. 3 Table omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(3)(b)
- F1590Word in Sch. 17 Pt. 5 Table substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(4)(a)
- F1591Words in Sch. 17 Pt. 5 Table omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(4)(b)
- F1592Words in Sch. 26 Pt. 1 heading substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 15
- F1593Reg. 3(5B) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 3(3)
- F1594Words in reg. 3(2) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 3(2)
- F1595Word in reg. 3(11) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 3(4)
- F1596Words in reg. 3(12)(b) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 3(5)
- F1597Words in reg. 3A heading substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(2)
- F1598Reg. 3A(6) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(7)
- F1599Reg. 3A(1) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(3)
- F1600Reg. 3A(2) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(3)
- F1601Words in reg. 3A(3) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(4)
- F1602Reg. 3A(4)(a) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(5)
- F1603Words in reg. 3A(5) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(6)
- F1604Words in reg. 8(1) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 5
- F1605Reg. 19(4E)(4F) substituted for reg. 19(4D) (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(4)
- F1606Words in reg. 19(4A) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(a)(i)
- F1607Words in reg. 19(4A) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(a)(ii)
- F1608Reg. 19(4A)(d) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(d)
- F1609Words in reg. 19(4A)(b) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(b)(i)
- F1610Word in reg. 19(4A)(b) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(b)(ii)
- F1611Word in reg. 19(4A)(c) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(c)
- F1612Reg. 19(4B) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(3)
- F1613Words in reg. 213(1) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 7
- F1614Words in reg. 233(8) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 8
- F1615Reg. 247A omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 10
- F1616Words in reg. 250(4A) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 11(a)
- F1617Words in reg. 250(4A) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 11(b)
- F1618Words in reg. 346(2)(c)(xxviiiga) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 12