Human Medicines Regulations 2012 · PART 1 General

8 General interpretation

reg. 8 Part 1 · in force: yes

Captured statutory text (L5)

8 General interpretation

(1)In these Regulations (unless the context otherwise requires)—

(1)“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;

(1)“the 2018 Regulations” means the Health Service Products (Provision and Disclosure of Information) Regulations 2018;

(1)“active implantable medical device”—

(1)has the meaning given in regulation 2 of the Medical Devices Regulations 2002; or

(1)to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 137 of those Regulations;

(1)“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;

(1)“administer” means administer to a human being—

(1)orally, by injection, or by introduction into the body in any other way; or

(1)by external application (whether or not by direct application to the body),

(1)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;

(1)...

(1)“adverse reaction” means a response to a medicinal product that is noxious and unintended;

(1)“advisory body” has the meaning given by regulation 12(1);

(1)“agreed paediatric investigation plan” means a paediatric investigation plan which the licensing authority has agreed in accordance with regulation 50B;

(1)“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;

(1)“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;

(1)“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;

(1)“appropriate practitioner” means an appropriate practitioner within the meaning of regulation 214;

(1)“Article 126a authorisation” means an authorisation granted by the licensing authority under Part 8 of these Regulations;

(1)“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;

(1)“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;

(1)“blood component” means any of the following—

(1)red cells;

(1)white cells;

(1)platelets; and

(1)plasma;

(1)“the British Pharmacopoeia” means the British Pharmacopoeia referred to in regulation 317;

(1)“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;

(1)“business” includes—

(1)a professional practice;

(1)any activity carried on by a body of persons whether corporate or unincorporated; and

(1)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—

(1)the National Health Service Act 2006 ,

(1)the Health and Personal Social Services (Northern Ireland) Order 1972 and the Health and Social Care (Reform) Act (Northern Ireland) 2009 ,

(1)the National Health Service (Wales) Act 2006 ,

(1)the National Health Service (Scotland) Act 1978 ;

(1)...

(1)“certificate of registration” means a certificate of registration granted by the licensing authority under Part 6 of these Regulations and—

(1)“COR(UK)” means such a certificate in force in the whole United Kingdom;

(1)“COR(GB)” means such a certificate in force in Great Britain only;

(1)“COR(NI)” means such a certificate in force in Northern Ireland only;

(1)“clinical management plan” means a written plan relating to the treatment of an individual patient and agreed by—

(1)the patient;

(1)the doctor or dentist who is a party to the plan; and

(1)any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;

(1)“clinical trial” has the meaning given by regulation 2 of the Clinical Trials Regulations;

(1)“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 ;

(1)“the Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004 ;

(1)“the Commission” has the meaning given by regulation 9(1);

(1)...

(1)“common name” in relation to a medicinal product, active substance or excipient means—

(1)its international non-proprietary name recommended by the World Health Organisation; or

(1)if such a name does not exist, its usual common name;

(1)“the Committee for Medicinal Products for Human Use” means the committee established under Article 5(1) of Regulation (EC) No 726/2004;

(1)“conditional marketing authorisation” means a UKMA(UK)(Category 1) granted under regulation 49(1)(a) in accordance with regulation 58F;

(1)“community practitioner nurse prescriber” means a person—

(1)who is a registered nurse or a registered midwife; and

(1)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;

(1)“contravention” includes failure to comply (and “contravene” has a corresponding meaning);

(1)“coronavirus” and “coronavirus disease” have the meanings given in section 1(1) of the Coronavirus Act 2020;

(1)“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—

(1)perfuming them;

(1)cleansing them;

(1)protecting them;

(1)caring for them or keeping them in condition;

(1)modifying their appearance (for aesthetic purposes or otherwise); or

(1)combating body odours or normal body perspiration;

(1)“country” means a country or territory;

(1)“dentist” means a person registered in the dentists register under section 14 of the Dentists Act 1984 ;

(1)“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;

(1)...

(1)“disease” includes any injury, ailment or adverse condition, whether of body or mind;

(1)“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;

(1)“doctor” means a registered medical practitioner;

(1)“EAMS medicinal product” means a medicinal product that—

(1)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

(1)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;

(1)“EAMS scientific opinion” is to be construed in accordance with regulation 167C(2)(b);

(1)“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;

(1)“Early Access to Medicines Scheme” means the scheme of that name established and operated under regulation 167C(1);

(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;

(1)“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)—

(1)by means of an electronic communications network within the meaning of section 32(1) of the Communications Act 2003 ; or

(1)by other means but while in an electronic form;

(1)“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;

(1)“the EMA” means the European Medicines Agency established by Regulation (EC) No 726/2004;

(1)“enactment” includes primary and secondary legislation of the devolved administrations in Wales, Scotland and Northern Ireland;

(1)“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;

(1)“EU agreed paediatric investigation plan” means a paediatric investigation plan agreed in accordance with the Paediatric Regulation;

(1)“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;

(1)“EU Exit Regulations” means the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019;

(1)“EU marketing authorisation” means a marketing authorisation granted or renewed by the European Commission under Regulation (EC) No 726/2004;

(1)“European Economic Area” or “EEA” means the European Economic Area created by the EEA agreement;

(1)“the European Pharmacopoeia” means the European Pharmacopoeia published by the European Directorate for the Quality of Medicines;

(1)“excipient” means any constituent of a medicinal product other than the active substance and the packaging material;

(1)“exempt advanced therapy medicinal product” has the meaning given in regulation 171;

(1)“expert advisory group” has the meaning given by regulation 14(1);

(1)“export” means export, or attempt to export, from the United Kingdom, whether by land, sea or air;

(1)“external use” in relation to a medicinal product—

(1)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

(1)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;

(1)“falsified medicinal product” means any medicinal product with a false representation of—

(1)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;

(1)its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

(1)its history, including the records and documents relating to the distribution channels used;

(1)“Fees Regulations” means the Medicines (Products for Human Use) (Fees) Regulations 2016;

(1)“general practitioner” means a medical practitioner who is included in the General Practitioner Register kept under section 34C of the Medical Act 1983;

(1)“the Good Manufacturing Practice Directive” means —

(1)in the case of a medicinal product manufactured or assembled in, or imported into, Great Britain—

(1)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

(1)if Regulations have been made under the powers in regulation B17(1), and have come into force, those Regulations;

(1)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;

(1)“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 ;

(1)“health care professional” means—

(1)a doctor;

(1)a dentist;

(1)a pharmacist;

(1)a pharmacy technician registered in Part 2 ... of the Register of pharmacists and pharmacy technicians established and maintained under article 19(2) of the Pharmacy Order 2010 ;

(1)a registered nurse;

(1)a registered midwife;

(1)a registered optometrist;

(1)a registered osteopath as defined in section 41 of the Osteopaths Act 1993 ;

(1)a registered chiropractor as defined in section 43 of the Chiropractors Act 1994 ;

(1)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; ...

(1)a person registered in the dental care professionals register established and maintained under section 36B of the Dentists Act 1984 as a member of a profession complementary to dentistry specified by regulation 2 of the General Dental Council (Professions Complementary to Dentistry) Regulations 2006 ; or

(1)a person registered under the Anaesthesia Associates and Physician Associates Order 2024

(1)“health centre” means a health centre maintained under—

(1)section 2 or 3 of the National Health Service Act 2006 ;

(1)section 2 or 3 of the National Health Service (Wales) Act 2006 ;

(1)section 36(1)(b) of the National Health Service (Scotland) Act 1978 ; or

(1)article 5 of the Health and Personal Social Services (Northern Ireland) Order 1972 ;

(1)...

(1)“herbal medicinal product” means a medicinal product whose only active ingredients are herbal substances or herbal preparations (or both);

(1)“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;

(1)“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;

(1)“homoeopathic medicinal product” means a medicinal product prepared from homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by—

(1)the European Pharmacopoeia; or

(1)in the absence of such a description in the European Pharmacopoeia,

(1)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;

(1)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;

(1)“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;

(1)“hospital” includes a clinic, nursing home or similar institution;

(1)“immediate packaging” in relation to a medicinal product means the container or other form of packaging immediately in contact with the medicinal product;

(1)“import” means import, or attempt to import, into the United Kingdom, whether by land, sea or air and “imported” is to be construed accordingly;

(1)“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);

(1)“intermediate product” means a substance which—

(1)has been manufactured for use in the manufacture of medicinal products; and

(1)is intended for further processing by a manufacturer of such products;

(1)“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);

(1)“investigational medicinal product” has the meaning given in regulation 2(1) of the Clinical Trials Regulations;

(1)“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);

(1)“the licensing authority” has the meaning given by regulation 6(2);

(1)“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;

(1)“local naloxone provider” is to be construed in accordance with regulation 237A(3);

(1)“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;

(1)“manufacturer's licence” has the meaning given by regulation 17(1);

(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;

(1)“manufacturer’s licence (POC)” means a manufacturer’s licence that relates to the manufacture or assembly of POC medicinal products specified in that licence;

(1)“marketing authorisation” means—

(1)a UK marketing authorisation; ...

(1)...

(1)“medicinal product subject to general sale” has the meaning given in regulation 5(1) (classification of medicinal products);

(1)“medical device”—

(1)has the meaning given in regulation 2 of the Medical Devices Regulations 2002; or

(1)to the extent necessary for the practical application of that definition, also or instead has the meaning given in regulation 69 of those Regulations;

(1)“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);

(1)“the Ministers” is to be construed in accordance with regulation 6(6) to (8);

(1)“MM” means modular manufacture;

(1)“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;

(1)“MM master file” means a detailed description of the arrangements for the manufacture or assembly of an MM medicinal product;

Full captured verbatim text

(1) In these Regulations (unless the context otherwise requires)—

“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;

...

“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—

the National Health Service Act 2006 ,

the Health and Personal Social Services (Northern Ireland) Order 1972 and the Health and Social Care (Reform) Act (Northern Ireland) 2009 ,

the National Health Service (Wales) Act 2006 ,

the National Health Service (Scotland) Act 1978 ;

...

“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 ;

“the Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004 ;

“the Commission” has the meaning given by regulation 9(1);

...

“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 ;

“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;

...

...

“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 ; 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 ;

“health care professional” means—

a doctor;

a dentist;

a pharmacist;

a pharmacy technician registered in Part 2 ... of the Register of pharmacists and pharmacy technicians established and maintained under article 19(2) of the Pharmacy Order 2010 ;

a registered nurse;

a registered midwife;

a registered optometrist;

a registered osteopath as defined in section 41 of the Osteopaths Act 1993 ;

a registered chiropractor as defined in section 43 of the Chiropractors Act 1994 ;

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; ...

a person registered in the dental care professionals register established and maintained under section 36B of the Dentists Act 1984 as a member of a profession complementary to dentistry specified by regulation 2 of the General Dental Council (Professions Complementary to Dentistry) Regulations 2006 ; or

a person registered under the Anaesthesia Associates and Physician Associates Order 2024

“health centre” means a health centre maintained under—

section 2 or 3 of the National Health Service Act 2006 ;

section 2 or 3 of the National Health Service (Wales) Act 2006 ;

section 36(1)(b) of the National Health Service (Scotland) Act 1978 ; or

article 5 of the Health and Personal Social Services (Northern Ireland) Order 1972 ;

...

“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—

a UK marketing authorisation; ...

...

“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;

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 statutory meanings for regulatory concepts, practitioners, devices, and communications.

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

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-2A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-3

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-3A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-4

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-6

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-7

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-8-part-1

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-8-part-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-8-part-3

synthesis coverage: missing/unverified L2 part-2

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

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-10

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-11

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-12

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-13

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-14

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-15

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-16

synthesis coverage: missing/unverified L2 part-3-chapter-1

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-A17

synthesis coverage: missing/unverified L2 part-3-chapter-1A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-B17

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-C17

synthesis coverage: missing/unverified L2 part-3-chapter-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-17

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-17A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-17B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-18

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-18A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-19

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-20

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-21

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-22

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-23

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-24

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-25

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-26

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-27

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-27A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-28

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-29

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-29A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-29B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-30

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-31

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-32

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-33

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

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-35

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-36

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-37

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-37A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-37B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-38

synthesis coverage: missing/unverified L2 part-3-chapter-2

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-39

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-40

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-41

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-42

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-43

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-43ZA

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-43A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-44

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45AA

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45AB

synthesis coverage: missing/unverified L2 part-3-chapter-3

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45D

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45E

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45F

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45G

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45H

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45I

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45J

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45K

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45L

synthesis coverage: missing/unverified L2 part-3-chapter-4

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45M

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45N

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45O

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45P

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45Q

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45R

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45S

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45T

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45U

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-45V

synthesis coverage: missing/unverified L2 part-4

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-46

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-47

synthesis coverage: missing/unverified L2 part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-48

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-49

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50D

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50E

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50F

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50G

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50H

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50I

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50J

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-50K

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-51

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-51A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-51B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-52

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-52A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-52B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-53

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-53A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-53B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-54

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-55

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-56

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-57

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-57A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58A

synthesis coverage: missing/unverified L2 part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58D

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58E

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58F

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-58G

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-59

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-60

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-60A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-60B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-61

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-62

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-63

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-64

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-64A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-65

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-65A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-65B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-65C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-66

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-66A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-66B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-67

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-68

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-69

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-70

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-71

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-72

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-73

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-74

synthesis coverage: missing/unverified L2 part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-74A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-74B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-75

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-76

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-77

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-78

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-78A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-78B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-79

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-80

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-80A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-A81

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-81

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-82

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-83

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-84

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-85

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-86

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-87

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-88

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-89

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-90

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-91

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-92

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-93

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-94

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-94A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-95

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-95A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-96

synthesis coverage: missing/unverified L2 part-5

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-97

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-98

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-99

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-100

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-101

synthesis coverage: missing/unverified L2 part-6

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-102

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-103

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-104

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-105

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-106

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-107

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-108

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-109

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-110

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-111

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-112

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-113

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-114

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-115

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-116

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-117

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-118

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-119

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-120

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-121

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-122

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-123

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-124

synthesis coverage: missing/unverified L2 part-7

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-124A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-125

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-125A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-126

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-126A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-127

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-128

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-129

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-130

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-130A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-131

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-133

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-136

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-139

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-142

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-143

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-143A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-144

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-145

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-146

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-147

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-148

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-148A

synthesis coverage: missing/unverified L2 part-7

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-149

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-150

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-151

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-153

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-154

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-155

synthesis coverage: missing/unverified L2 part-8

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-156

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-157

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-158

synthesis coverage: missing/unverified L2 part-9

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-159

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-160

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-166

synthesis coverage: missing/unverified L2 part-10

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167C

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167D

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167E

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167F

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167G

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-167H

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-168

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-169

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-170

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-170A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-170B

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-171

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-172

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-174

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-174A

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-175

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-176

synthesis coverage: missing/unverified L2 part-11

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-177

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-178

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-179

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-185

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-186

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-186A

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-191A

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-196A

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synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-202

synthesis coverage: missing evaluation uk:uksi/2012/1916#regulation-202A

synthesis coverage: missing/unverified L2 part-11

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synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-22

synthesis coverage: missing evaluation uk:uksi/2012/1916#schedule-34-paragraph-23

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 085cfe9090cdf07fbbd3b18b…
Source: legislation.gov.uk/uksi/2012/1916