As last captured

Human Medicines Regulations 2012 · PART 1 General

8 General interpretation

reg. 8 Part 2 · in force: yes

Captured statutory text (L5)

8 General interpretation

(1)“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;
(1)“modular unit” means a relocatable manufacturing unit;
(1)“naloxone product” means a medicinal product that contains naloxone or a salt, ester or stereoisomeric form of naloxone;
(1)“name” in relation to a medicinal product means—
(1)where the product has a UK marketing authorisation or traditional herbal registration, the name—
(1)as approved by the licensing authority in granting the authorisation or registration, or
(1)where that name has been varied since that approval, as so amended;
(1)... and
(1)where the product has an Article 126a authorisation, the name—
(1)as approved by the licensing authority to appear on the packaging and any package leaflet of the product under the authorisation, or
(1)where that name has been varied since that approval, as so amended;
(1)“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;
(1)“NHS dispensing practice” means the business as part of which NHS pharmaceutical services are provided by general practitioners;
(1)“NHS pharmaceutical services” means—
(1)in England, pharmaceutical services under Part 7 of the National Health Service Act 2006;
(1)in Wales, pharmaceutical services under Part 7 of the National Health Service (Wales) Act 2006;
(1)in Scotland, pharmaceutical services under Part 2 of the National Health Service (Scotland) Act 1978;
(1)in Northern Ireland, pharmaceutical services under Part 6 of the Health and Personal Social Services (Northern Ireland) Order 1972;
(1)“NHS primary dental services” means—
(1)in relation to England, primary dental services under the National Health Service Act 2006;
(1)in relation to Wales, primary dental services under the National Health Service (Wales) Act 2006;
(1)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 ; and
(1)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 ;
(1)“NHS primary medical services” means—
(1)in relation to England, primary medical services under the National Health Service Act 2006;
(1)in relation to Wales, primary medical services under the National Health Service (Wales) Act 2006;
(1)in relation to Scotland, primary medical services under the National Health Service (Scotland) Act 1978; and
(1)in relation to Northern Ireland, primary medical services under the Health and Personal Social Services (Northern Ireland) Order 1972;
(1)“NIMAR” means Northern Ireland MHRA authorised route;
(1)“nurse independent prescriber” means a person who—
(1)is a registered nurse or registered midwife; and
(1)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;
(1)“nursing home” has the meaning given by article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;
(1)“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;
(1)“optometrist independent prescriber” means a person—
(1)who is a registered optometrist; and
(1)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;
(1)“orphan criteria” means the criteria listed in regulation 50G(2);
(1)“orphan marketing authorisation” means a UK marketing authorisation granted under regulation 49(1)(a) in accordance with regulation 58C;
(1)“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;
(1)“outer packaging” in relation to a medicinal product means any packaging into which the immediate packaging of the medicinal product is placed;
(1)“package” in relation to a medicinal product, includes—
(1)a container of the product;
(1)any box, packet or other article in which one or more containers of the product are or are to be enclosed; and
(1)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;
(1)“package leaflet” in relation to a medicinal product, means a leaflet that accompanies the product and contains information for the user of the product;
(1)“paediatric clinical trial” means a clinical trial conducted in whole or in part on persons under the age of 18 years;
(1)“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;
(1)“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;
(1)“paediatric population” means that part of the population consisting of persons under the age of 18 years;
(1)“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 ;
(1)“parallel import licence” has the meaning given in regulation 48(2);
(1)“paramedic independent prescriber” means a person—
(1)who is a registered paramedic; and
(1)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;
(1)“periodic safety update report” or “PSUR” has the meaning given in regulation 191 (obligation on holder to submit periodic safety update reports: general requirements);
(1)“pharmacist” means—
(1)in relation to Great Britain a person registered in Part 1 ... of the Register of pharmacists and pharmacy technicians maintained under article 19(2) of the Pharmacy Order 2010 ; and
(1)in relation to Northern Ireland a person registered in the register of pharmaceutical chemists for Northern Ireland ... maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 ;
(1)“pharmacist independent prescriber” means a person who—
(1)is a pharmacist; and
(1)is noted in the relevant register as qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;
(1)“the Pharmacovigilance Risk Assessment Committee” means the committee of the EMA established by Article 56(1)(aa) of Regulation (EC) No 726/2004;
(1)“pharmacovigilance system” means a system used by the holder of a UK marketing authorisation ..., 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;
(1)“pharmacovigilance system master file” means a detailed description of the pharmacovigilance system used by the holder of a UK marketing authorisation ..., traditional herbal registration or Article 126a authorisation with respect to one or more authorised or registered medicinal products;
(1)“pharmacy medicine” has the meaning given in regulation 5(5) (classification of medicinal products);
(1)“physiotherapist independent prescriber” means a person—
(1)who is a registered physiotherapist; and
(1)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;
(1)“POC” means point of care;
(1)“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;
(1)“POC master file” means a detailed description of the arrangements for the manufacture or assembly of a POC medicinal product;
(1)“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;
(1)“POC site” means a site at which the manufacture or assembly of a POC medicinal product takes place;
(1)“podiatrist independent prescriber” means a person—
(1)who is a registered podiatrist; and
(1)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;
(1)“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;
(1)“post-authorisation safety study” means any study relating to a medicinal product to which a UK marketing authorisation ..., traditional herbal registration or Article 126a authorisation relates that is conducted with the aim of—
(1)identifying, characterising or quantifying a safety hazard;
(1)confirming the safety profile of the medicinal product; or
(1)measuring the effectiveness of risk management measures;
(1)“prescription only medicine” has the meaning given in regulation 5(3) (classification of medicinal products);
(1)“product information” in relation to a medicinal product means—
(1)the summary of the product characteristics;
(1)the immediate and outer packaging; and
(1)the package leaflet;
(1)“the professional register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001 ;
(1)“provider of probation services”—
(1)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
(1)in Northern Ireland, means the Probation Board for Northern Ireland;
(1)“provider of youth justice services” means—
(1)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);
(1)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
(1)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);
(1)“the Psychotropic Substances Convention” means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971;
(1)“qualified person”, except in relation to the expression “appropriately qualified person”, means—
(1)a person who satisfies the requirements specified in Part 1 or 2 of Schedule 7; or
(1)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;
(1)“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;
(1)“radiation emergency” has the meaning given by regulation 2(1) of the Radiation (Emergency Preparedness and Public Information) Regulations 2019;
(1)“radionuclide” means a radioactive isotope;
(1)“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;
(1)“radionuclide kit” means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration;
(1)“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;
(1)“radiopharmaceutical” means a medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose;
(1)“registered dietitian” means a person registered in Part 4 of the Health and Care Professions Council register;
(1)“registered midwife” means a person registered in the Midwives Part of the professional register;
(1)“registered nurse” means a person registered in the Nurses Part or the Specialist Community Public Health Nurses Part of the professional register;
(1)“registered optometrist” means a person whose name is entered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989 ...;
(1)“registered paramedic” means a person who is registered in Part 8 of the Health and Care Professions Council register;
(1)“registered pharmacy” means—
(1)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 ; and
(1)in relation to Northern Ireland, premises entered in the register required to be kept under section 75 of the Medicines Act 1968;
(1)“registered physiotherapist” means a person registered in Part 9 of the Health and Care Professions Council register;
(1)“registered podiatrist” means a person registered in Part 2 of the Health and Care Professions Council register;
(1)“registered radiographer” means a person registered in Part 11 of the Health and Care Professions Council register;
(1)“registrable homoeopathic medicinal product” means a homoeopathic medicinal product to which regulation 102 applies;
(1)“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;
(1)...
(1)“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 , as it has effect in EU law;
(1)“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;
(1)“relevant European State” means an EEA State or Switzerland;
(1)“relevant medicinal product” has the meaning given by regulation 48;
(1)“the relevant register” means—
(1)in relation to a pharmacist—
(1)in Great Britain, Part 1 of the Register of pharmacists and pharmacy technicians maintained under article 19(2) of the Pharmacy Order 2010, or
(1)in Northern Ireland, the register maintained in pursuance of articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;
(1)in relation to a registered nurse or registered midwife, the professional register;
(1)in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989 ...; and
(1)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—
(1)chiropodists and podiatrists,
(1)physiotherapists, ...
(1)radiographers, ...
(1)orthoptists , or
(1)paramedics;
(1)“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;
(1)“risk management plan” means a detailed description of the risk management system;
(1)“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;
(1)“serious adverse reaction” means an adverse reaction that—
(1)results in a person's death;
(1)threatens a person's life;
(1)results in a person being hospitalised as an inpatient or prolongs a person's existing stay in hospital;
(1)results in a person's persistent or significant disability or incapacity; or
(1)results in a congenital anomaly or birth defect;
(1)“special medicinal product” means a product within the meaning of regulation 167 or any equivalent legislation in a country other than the United Kingdom;
(1)“substance” means any matter regardless of its origins and includes—
(1)human substances (such as human blood and human blood products);
(1)animal substances (such as micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts and blood products);
(1)vegetable substances (such as micro-organisms, plants, parts of plants, vegetable secretions and extracts);
(1)chemical substances (such as elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis); and
(1)gases and vapours;
(1)“the summary of the product characteristics” in relation to a medicinal product means—
(1)where the product has a UK marketing authorisation or traditional herbal registration, the summary of the product characteristics—
(1)as approved by the licensing authority in granting the authorisation or registration, or
(1)where the summary has been varied since that approval, as so amended; or
(1)where the product has an EU marketing authorisation, the summary of the product characteristics—
(1)as approved by the European Commission in granting the authorisation, or
(1)where the summary has been varied since that approval, as so amended;
(1)“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—
(1)a pharmacist;
(1)a registered midwife;
(1)a registered nurse;
(1)a chiropodist, podiatrist, physiotherapist, paramedic or radiographer; ...
(1)a registered optometrist; or
(1)a registered dietitian;
(1)“supplementary protection certificate” has the meaning given in section 128B(2) of the Patents Act 1977;
(1)“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;
Full captured verbatim text
“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;

... 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 ; 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 ;

“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 ;

“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—

in relation to Great Britain a person registered in Part 1 ... of the Register of pharmacists and pharmacy technicians maintained under article 19(2) of the Pharmacy Order 2010 ; and

in relation to Northern Ireland a person registered in the register of pharmaceutical chemists for Northern Ireland ... maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 ;

“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 ..., 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 ..., 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 ..., 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 ;

“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 optometrist” means a person whose name is entered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989 ...;

“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 ; and

in relation to Northern Ireland, premises entered in the register required to be kept under section 75 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;

...

“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 , 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 ...; 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—

chiropodists and podiatrists,

physiotherapists, ...

radiographers, ...

orthoptists , or

paramedics;

“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; ...

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;

What this provision means

Model summary, checked against the text on the left.

Relevance to Signicat: 1/3 · detailed summary (L4) Status: not needed for a short provision · Stored artifact; current recipe verification unavailable

General interpretation definitions establish terms for manufacturing models, prescriptions, healthcare registers, and pharmacovigilance.

Only the one-line summary above is stored for this provision; the text itself is the evidence.

Refers to

No captured references.

Referred to by

No captured references.

Part summaries

0 of 0 parts have a verified summary.

L1 unavailable for current verification: the overall summary needs every part verified. Provisions and the verified summaries remain readable.

Verification findings (1458)

synthesis coverage: missing/unverified L2 part-1

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-1

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-9

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synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-24

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-25

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-26

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-27

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-28

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-29

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-30

synthesis coverage: missing/unverified L2 schedule-34-part-1

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-31

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-32

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-33

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-34

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-35

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-36

synthesis coverage: missing/unverified L2 schedule-34-part-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-37

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-38

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-39

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-40

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-41

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-42

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-43

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-44

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-45

synthesis coverage: missing/unverified L2 schedule-34-part-3

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-46

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-47

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-48

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-49

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-50

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-51

synthesis coverage: missing/unverified L2 schedule-34-part-4

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-52

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-53

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-54

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-55

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-56

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-57

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-58

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-59

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-60

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-61

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-62

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-63

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-64

synthesis coverage: missing/unverified L2 schedule-34-part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-65

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-66

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-67

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-68

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-69

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-70

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-71

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-72

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-73

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-74

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-75

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-76

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-77

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-78

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-79

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-80

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-81

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-82

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-83

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-84

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-85

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-86

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-87

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-88

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-89

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-90

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-91

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-92

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-93

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-94

synthesis coverage: missing/unverified L2 schedule-34-part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-95

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-96

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-97

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-98

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-99

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-100

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-101

synthesis coverage: missing/unverified L2 schedule-34-part-6

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-102

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-103

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-104

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-105

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-106

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-107

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-108

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-109

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-110

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-111

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-112

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-113

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-114

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-115

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-116

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-117

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-118

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-119

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-120

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-121

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-122

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-123

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-124

Instrument tier unavailable

Change history as published

Reg. 32 revoked (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 35

Reg. 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

Reg. 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

Reg. 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

Reg. 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

Reg. 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

Reg. 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)

Regs. 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 · repeated 8×

Reg. 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)

Reg. 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

Reg. 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)

Reg. 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)

Reg. 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

Reg. 247A omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 10

Reg. 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)

Reg. 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)

Reg. 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)

Reg. 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

Reg. 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

Sch. 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))

Sch. 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))

Sch. 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))

Sch. 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))

Sch. 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))

Sch. 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)

Sch. 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)

Sch. 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)

Sch. 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) · repeated 6×

Sch. 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

Sch. 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.

Sch. 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)

Sch. 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)

Pending effects amendments not yet applied to this text

reg. 38 heading words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 29(2) · Effective date unknown

reg. 149 heading word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 131(2) · Effective date unknown

Pt. 8 omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 132 · Effective date unknown

reg. 210A heading words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 175(2) · Effective date unknown

reg. 196 and cross-heading substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 156 · Effective date unknown

Show all 200

Pt. 12A omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 197 · Effective date unknown

reg. 3(12)(d)(ii) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 5(2)(b) · Effective date unknown · reg. 3

reg. 3(12)(d)(iv) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 5(2)(c) · Effective date unknown · reg. 3

reg. 3(15)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 5(3)(b) · Effective date unknown · reg. 3

reg. 3(15)(d) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 5(3)(c) · Effective date unknown · reg. 3

reg. 5(1)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(2) · Effective date unknown · reg. 5

reg. 5(2)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(3)(a) · Effective date unknown · reg. 5

reg. 5(2)(d) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(3)(b) · Effective date unknown · reg. 5

reg. 5(3)(b) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(4)(a) · Effective date unknown · reg. 5

reg. 5(3)(d) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(4)(b) · Effective date unknown · reg. 5

reg. 5(4)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(5) · Effective date unknown · reg. 5

reg. 5(5)(b) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(6)(a) · Effective date unknown · reg. 5

reg. 5(5)(d) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 7(6)(b) · Effective date unknown · reg. 5

reg. 6(3)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 9(a) · Effective date unknown · reg. 6

reg. 6(4) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 9(b) · Effective date unknown · reg. 6

reg. 6(5) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 9(b) · Effective date unknown · reg. 6

reg. 8(1) words inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 10(3)(a) · Effective date unknown

reg. 8(1) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 10(3)(d) · Effective date unknown

reg. 17(1)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 14(2) · Effective date unknown · reg. 17

reg. 17(3)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 14(3) · Effective date unknown · reg. 17

reg. 17(4) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 14(4) · Effective date unknown · reg. 17

reg. 17(5) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 14(5) · Effective date unknown · reg. 17

reg. 18(1)(c) words omitted by virtue of S.I. 2019/775, reg. 15(2)(c) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 2 · Effective date unknown · reg. 18

reg. 18(6) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 15(3) · Effective date unknown · reg. 18

reg. 18(7) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 15(4) · Effective date unknown · reg. 18

reg. 19(1)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 17(2) · Effective date unknown · reg. 19

reg. 19(6) inserted by S.I. 2019/775, reg. 17(4) (as inserted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 3 · Effective date unknown · reg. 19

reg. 26(5)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 21 · Effective date unknown · reg. 26

reg. 31(5)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 24(3) · Effective date unknown · reg. 31

reg. 36(4)-(7) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 27 · Effective date unknown · reg. 36

reg. 37(4)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 28(2)(a) · Effective date unknown · reg. 37

reg. 37(5)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 28(3) · Effective date unknown · reg. 37

reg. 37(6)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 28(4) · Effective date unknown · reg. 37

reg. 38(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 29(3) · Effective date unknown · reg. 38

reg. 38(3)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 29(3) · Effective date unknown · reg. 38

reg. 42(1) word substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 31(2) · Effective date unknown · reg. 42

reg. 42(4) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 31(3) · Effective date unknown · reg. 42

reg. 43(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(2) · Effective date unknown · reg. 43

reg. 43(5)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(3) · Effective date unknown · reg. 43

reg. 43(6)(b) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(4)(b) · Effective date unknown · reg. 43

reg. 43(7)(b)(i) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(5)(a)(i) · Effective date unknown · reg. 43

reg. 43(7)(b)(ii) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(3) · Effective date unknown · reg. 43

reg. 43(7)(c)(vii) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(5)(b) · Effective date unknown · reg. 43

reg. 43(8)(8A) substituted for reg. 43(8) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(6) · Effective date unknown · reg. 43

reg. 43(10) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(7) · Effective date unknown · reg. 43

reg. 43(11) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(7) · Effective date unknown · reg. 43

reg. 43(13) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(8) · Effective date unknown · reg. 43

reg. 43(15) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 33(9) · Effective date unknown · reg. 43

reg. 43A omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 34 · Effective date unknown · reg. 43A

reg. 44(2)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(2)(a) · Effective date unknown · reg. 44

reg. 44(2)(c) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(2)(b) · Effective date unknown · reg. 44

reg. 44(5)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(3) · Effective date unknown · reg. 44

reg. 44(5)(e) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(4)(a) · Effective date unknown · reg. 44

reg. 44(6)(e) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 35(5)(b) · Effective date unknown · reg. 44

reg. 45(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 36(2) · Effective date unknown · reg. 45

reg. 45(2)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 36(3) · Effective date unknown · reg. 45

reg. 45A(1)(a)(i)(ii) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(2)(a) · Effective date unknown · reg. 45A

reg. 45A(1)(b)(i) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(2)(b)(i) · Effective date unknown · reg. 45A

reg. 45A(1)(b)(ii) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(2)(b)(ii) · Effective date unknown · reg. 45A

reg. 45A(1)(b)(iii) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(2)(b)(iii) · Effective date unknown · reg. 45A

reg. 45A(2)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(3)(a) · Effective date unknown · reg. 45A

reg. 45A(2)(c) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 38(3)(b) · Effective date unknown · reg. 45A

reg. 45E(3)(b)(i) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 40(a) · Effective date unknown · reg. 45E

reg. 45E(3)(d)(iii) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 40(b) · Effective date unknown · reg. 45E

reg. 45M(2)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 42(2) · Effective date unknown · reg. 45M

reg. 45O(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(2) · Effective date unknown · reg. 45O

reg. 45O(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(3) · Effective date unknown · reg. 45O

reg. 45O(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(4)(a) · Effective date unknown · reg. 45O

reg. 45O(3)(c) word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(4)(c)(i) · Effective date unknown · reg. 45O

reg. 45O(3)(c)(ii) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(4)(c)(ii) · Effective date unknown · reg. 45O

reg. 45O(3)(c)(iii) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(4)(c)(iii) · Effective date unknown · reg. 45O

reg. 45O(4)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(5)(a) · Effective date unknown · reg. 45O

reg. 45O(4)(b)(i) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 44(5)(b) · Effective date unknown · reg. 45O

reg. 46(2)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(2)(b) · Effective date unknown · reg. 46

reg. 46(2)(d) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(2)(c) · Effective date unknown · reg. 46

reg. 46(6)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(4)(a) · Effective date unknown · reg. 46

reg. 46(6)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(4)(b) · Effective date unknown · reg. 46

reg. 46(6)(d) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(4)(c) · Effective date unknown · reg. 46

reg. 46(7)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 45(5) · Effective date unknown · reg. 46

reg. 47(6) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 46(3) · Effective date unknown · reg. 47

reg. 48(2) words inserted by S.I. 2019/775, reg. 47(2)(a) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 4(a) · Effective date unknown · reg. 48

reg. 48(2) words omitted by virtue of S.I. 2019/775, reg. 47(2)(d) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 4(b)(i) · Effective date unknown · reg. 48

reg. 48(2) words inserted by S.I. 2019/775, reg. 47(2)(d) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 4(b)(ii) · Effective date unknown · reg. 48

reg. 49(1A) inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 48(3) · Effective date unknown · reg. 49

reg. 49(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 48(4) · Effective date unknown · reg. 49

reg. 49(9) inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 48(6) · Effective date unknown · reg. 49

reg. 50(4) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 49(2) · Effective date unknown · reg. 50

reg. 51 substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 56 · Effective date unknown · reg. 51

reg. 51(9) words inserted by S.I. 2019/775, reg. 56 (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 5 · Effective date unknown · reg. 51

reg. 52(1)(a)(i)(ii) and words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 57(2) · Effective date unknown · reg. 52

reg. 52(1)(b) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 57(3) · Effective date unknown · reg. 52

reg. 52(2) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 57(4) · Effective date unknown · reg. 52

reg. 52(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 57(5)(a) · Effective date unknown · reg. 52

reg. 53(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 58(2) · Effective date unknown · reg. 53

reg. 53(2)-(2C) substituted for reg. 53(2) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 58(3) · Effective date unknown · reg. 53

reg. 53(2)(a) substituted by S.I. 2019/775, reg. 58(3) (as amended) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 6(2) · Effective date unknown · reg. 53

reg. 53(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 58(4)(a) · Effective date unknown · reg. 53

reg. 53(3) words substituted by S.I. 2019/775, reg. 58(4)(a) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 6(3) · Effective date unknown · reg. 53

reg. 55(1)(a) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 60(2) · Effective date unknown · reg. 55

reg. 55(2) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 60(3) · Effective date unknown · reg. 55

reg. 58(6) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 62(3) · Effective date unknown · reg. 58

reg. 58(7) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 62(3) · Effective date unknown · reg. 58

reg. 59(3) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 65(2) · Effective date unknown · reg. 59

reg. 59(3A)(3B) inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 65(3) · Effective date unknown · reg. 59

reg. 59(5) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 65(6) · Effective date unknown · reg. 59

reg. 60(9) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 66 · Effective date unknown · reg. 60

reg. 60A inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 67 · Effective date unknown · reg. 60A

reg. 61(6) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 68(3) · Effective date unknown · reg. 61

reg. 61(7)-(7B) substituted for reg. 61(7) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 68(4) · Effective date unknown · reg. 61

reg. 61(13) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 68(5) · Effective date unknown · reg. 61

reg. 64(4)(d) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 69 · Effective date unknown · reg. 64

reg. 66(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 74 · Effective date unknown · reg. 66

reg. 68(7) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 77(3)(b) · Effective date unknown · reg. 68

reg. 68(9) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 77(5) · Effective date unknown · reg. 68

reg. 71(1)(b) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 80(2)(b)(i) · Effective date unknown · reg. 71

reg. 71(1)(b) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 80(2)(b)(ii) · Effective date unknown · reg. 71

reg. 72(1) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 81 · Effective date unknown · reg. 72

reg. 73(5C) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 82(3) · Effective date unknown · reg. 73

reg. 76(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 84 · Effective date unknown · reg. 76

reg. 77 word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 85 · Effective date unknown · reg. 77

reg. 78 word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 86 · Effective date unknown · reg. 78

reg. 79 omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 88 · Effective date unknown · reg. 79

reg. 80(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 89(3) · Effective date unknown · reg. 80

reg. 80(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 89(4) · Effective date unknown · reg. 80

reg. 80(c) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 89(5) · Effective date unknown · reg. 80

reg. 81-94 omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 90 · Effective date unknown

reg. 94A omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 91 · Effective date unknown · reg. 94A

reg. 95 word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 92(2) · Effective date unknown · reg. 95

reg. 95(c) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 92(3) · Effective date unknown · reg. 95

reg. 95(d) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 92(3) · Effective date unknown · reg. 95

reg. 96(1) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 93(2)(a) · Effective date unknown · reg. 96

reg. 96(1)(b) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 93(2)(b) · Effective date unknown · reg. 96

reg. 96(1)(c) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 93(2)(b) · Effective date unknown · reg. 96

reg. 96(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 93(3) · Effective date unknown · reg. 96

reg. 97 words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 94(2)(a) · Effective date unknown · reg. 97

reg. 98(2)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 95 · Effective date unknown · reg. 98

reg. 99(1) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 96(2) · Effective date unknown · reg. 99

reg. 99(2) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 96(3) · Effective date unknown · reg. 99

reg. 101(1) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 97(2) · Effective date unknown · reg. 101

reg. 101(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 97(3) · Effective date unknown · reg. 101

reg. 103(4) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 99(2) · Effective date unknown · reg. 103

reg. 104(5) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 100 · Effective date unknown · reg. 104

reg. 104(6) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 100 · Effective date unknown · reg. 104

reg. 108(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 101 · Effective date unknown · reg. 108

reg. 110(7) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 102(2) · Effective date unknown · reg. 110

reg. 110(10) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 102(3) · Effective date unknown · reg. 110

reg. 116(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 107 · Effective date unknown · reg. 116

reg. 125(5)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 110 · Effective date unknown · reg. 125

reg. 127(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 113 · Effective date unknown · reg. 127

reg. 128(3) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 114 · Effective date unknown · reg. 128

reg. 130(7) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(3) · Effective date unknown · reg. 130

reg. 130(8) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(4) · Effective date unknown · reg. 130

reg. 130(9) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(5) · Effective date unknown · reg. 130

reg. 130(10)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(6) · Effective date unknown · reg. 130

reg. 130(12) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(7) · Effective date unknown · reg. 130

reg. 130(13) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 116(7) · Effective date unknown · reg. 130

reg. 133(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 118 · Effective date unknown · reg. 133

reg. 135(7)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 119(2) · Effective date unknown · reg. 135

reg. 135(8) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 119(3) · Effective date unknown · reg. 135

reg. 135(9)(b) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 119(4) · Effective date unknown · reg. 135

reg. 136(1)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 120(2) · Effective date unknown · reg. 136

reg. 140(1)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 123 · Effective date unknown · reg. 140

reg. 142(5C) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 125 · Effective date unknown · reg. 142

reg. 144 words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 127 · Effective date unknown · reg. 144

reg. 146(2) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 129 · Effective date unknown · reg. 146

reg. 149(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 131(3) · Effective date unknown · reg. 149

reg. 149(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 131(4) · Effective date unknown · reg. 149

reg. 149(c) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 131(5) · Effective date unknown · reg. 149

reg. 159(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 133(b) · Effective date unknown · reg. 159

reg. 164(2)(b) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 134(b) · Effective date unknown · reg. 164

reg. 168(8)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 135(a) · Effective date unknown · reg. 168

reg. 168(8)(b) substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 135(b) · Effective date unknown · reg. 168

reg. 169(9)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 136 · Effective date unknown · reg. 169

reg. 171(2)(c) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 137 · Effective date unknown · reg. 171

reg. 173(c) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 138 · Effective date unknown · reg. 173

reg. 177(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(2)(a) · Effective date unknown · reg. 177

reg. 177(1) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(2)(b) · Effective date unknown · reg. 177

reg. 177(1)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(2)(c) · Effective date unknown · reg. 177

reg. 177(1)(c) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(2)(d) · Effective date unknown · reg. 177

reg. 177(2)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(3)(b) · Effective date unknown · reg. 177

reg. 177(2)(c) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(3)(c) · Effective date unknown · reg. 177

reg. 177(3)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(4)(b) · Effective date unknown · reg. 177

reg. 177(3)(c) and word omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(4)(c) · Effective date unknown · reg. 177

reg. 177(4) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(5) · Effective date unknown · reg. 177

reg. 177(5) words omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 139(6) · Effective date unknown · reg. 177

reg. 177(5) words substituted by S.I. 2019/775, reg. 139(6)(a) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 8 · Effective date unknown · reg. 177

reg. 177(5) word omitted by virtue of S.I. 2019/775, reg. 139(6)(b) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 8 · Effective date unknown · reg. 177

reg. 177(5) words inserted by S.I. 2019/775, reg. 139(6)(c) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 8 · Effective date unknown · reg. 177

reg. 177(5) word omitted by virtue of S.I. 2019/775, reg. 139(6)(d) (as substituted) by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Sch. 1 para. 8 · Effective date unknown · reg. 177

reg. 181 omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 141 · Effective date unknown · reg. 181

reg. 182(2)(a) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 142(2) · Effective date unknown · reg. 182

reg. 182(3) words inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 142(3) · Effective date unknown · reg. 182

reg. 186(1)(a) word inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 145(a) · Effective date unknown · reg. 186

reg. 186(1)(c)-(e) omitted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 145(b) · Effective date unknown · reg. 186

reg. 187(1) words substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 reg. 147(2) · Effective date unknown · reg. 187

Provenance

Every claim the system makes about this text is traceable to these identifiers.

Instrument
uk:uksi/2012/1916
Part
PART 1 General
Version
257dcf45b9193c8bf67392a8…
Content hash
sha256 58abd4677be4e90769da10c7…
Source
legislation.gov.uk/uksi/2012/1916