PART 1 General

Citation and commencement

1. —(1) These Regulations may be cited as the Human Medicines Regulations 2012.

(2) These Regulations come into force on 14th August 2012.

Medicinal products

2. —(1) In these Regulations “ medicinal product ” means—

(a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or

(b) any substance or combination of substances that may be used by or administered to human beings with a view to—

(i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or

(ii) making a medical diagnosis.

(2) These Regulations do not apply to—

(a) whole human blood; or

(b) any human blood component, other than plasma prepared by a method involving an industrial process.

Definition of advanced therapy medicinal product etc.

2A.—(1) In these Regulations ... “ advanced therapy medicinal product ” means any of the following products—

(a) a gene therapy medicinal product;

(b) a somatic cell therapy medicinal product; or

(c) a tissue engineered product.

(2) A “gene therapy medicinal product” is a biological medicinal product which has the following characteristics—

(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; and

(b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.

(3) A vaccine against infectious diseases is not to be treated as a gene therapy medicinal product.

(4) A “somatic cell medicinal product” is a medicinal product which has the following characteristics—

(a) it contains or consists of cells or tissues that—

(i) have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or

(ii) are not intended to be used for the same essential function in the recipient as in the donor; and

(b) it is presented as having properties for, or is used in or administered to human beings with a view to, treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

(5) A “tissue engineered product” is a medicinal product which—

(a) contains or consists of engineered cells or tissues; and

(b) is presented as having properties for, or is used in or administered to human beings with a view to, regenerating, repairing or replacing a human tissue.

(6) A tissue engineered product may contain—

(a) cells or tissues of human or animal origin;

(b) viable or non-viable cells or tissues; and

(c) additional substances, including cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices.

(7) A product is not a tissue engineered product if it—

(a) contains or consists exclusively of non-viable human or animal cells or tissues;

(b) does not contain any viable cells or tissues; and

(c) does not act principally by pharmacological, immunological or metabolic action.

(8) Cells or tissues are engineered if they—

(a) have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved; or

(b) are not intended to be used for the same essential function in the recipient as in the donor.

(9) The following manipulations are not substantial manipulations for the purposes of paragraphs (4)(a) and (8)(a)—

(a) cutting;

(b) grinding;

(c) shaping;

(d) centrifugation;

(e) soaking in antibiotic or antimicrobial solutions;

(f) sterilisation;

(g) irradiation;

(h) cell separation, concentration or purification;

(i) filtering;

(j) lyophilisation;

(k) freezing;

(l) cryopreservation; and

(m) vitrification.

(10) In these Regulations ... “ combined advanced therapy medicinal product ” means an advanced therapy medicinal product—

(a) which incorporates, as an integral part of the product, one or more medical devices or one or more active implantable medical devices; and

(b) the cellular part of which—

(i) contains viable cells or tissues; or

(ii) contains non-viable cells or tissues which are liable to act upon the human body with action that can be considered as primary to that of the medical devices.

(11) Where an advanced therapy medicinal product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues is to be treated as the principal mode of action of the product.

(12) An advanced therapy medicinal product containing both autologous and allogeneic cells or tissues is to be treated as being for allogeneic use.

(13) A product which falls within the definition of a tissue engineered product and within the definition of a somatic cell therapy medicinal product is to be treated as a tissue engineered product.

(14) A product which falls within the definition of—

(a) a somatic cell therapy medicinal product or a tissue engineered product; and

(b) a gene therapy medicinal product,

is to be treated as a gene therapy medicinal product.

Scope of these Regulations: special provisions

3. —(1)Regulation 17(1) (manufacturing of medicinal products: requirement for licence) shall not apply in circumstances where paragraph (4) applies.

(2) Regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) shall not apply in circumstances where paragraph (5) or (6) applies.

(3) These Regulations do not apply where paragraph (7) applies.

(4) This paragraph applies where a medicinal product is assembled by a registered nurse or a registered midwife if—

(a) the nurse or midwife is acting in the course of his or her profession; and

(b) the conditions in paragraphs (8) and (9) are met.

(5) This paragraph applies where a medicinal product is manufactured or assembled by a doctor or dentist and the conditions in paragraphs (8) and (9) are met.

(6) This paragraph applies where a herbal medicinal product is manufactured or assembled by a person (“A”) if—

(a) the manufacture or assembly takes place on premises occupied by A and from which A can exclude the public;

(b) the product is for administration to a person (“B”) and A has been requested by or on behalf of B, and in B's presence, to use A's judgment as to the treatment required;

(c) the product does not contain a substance specified in Part 1 of Schedule 20;

(d) the product does not contain a substance listed in Part 2 of that Schedule, unless the product is sold or supplied—

(i) in or from containers or packages labelled to show a dose not exceeding the maximum dose or maximum daily dose specified in column 2 of that Part, or

(ii) in the case of a product for external use only, with a percentage of the substance in the product that does not exceed the percentage specified in column 3 of that Part; and

(e) the condition in paragraph (9) is met.

(7) This paragraph applies where the product is a radionuclide that is in the form of a sealed source.

(8) This condition is that the medicinal product is supplied—

(a) to a patient in the course of the treatment of that patient; or

(b) in a case to which paragraph (5) applies, to a patient of another doctor or dentist who is a member of the same medical or dental practice.

(9) This condition is that the medicinal product is not manufactured or, as the case may be, assembled—

(a) on a large scale; or

(b) by an industrial process.

(10) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products) does not apply to a medicinal product that is sold or supplied in circumstances where paragraph (11) or (12) applies in relation to the product, except to the extent set out in paragraph (14), but the requirements of paragraph (13) shall apply.

(11) This paragraph applies where a medicinal product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of paragraph (5) or (6).

(12) This paragraph applies in the case of a medicinal product where—

(a) the product is the result of a process of assembly of an authorised medicinal product;

(b) regulation 17(1) does not apply to the process of assembly by virtue of paragraph (4) or (5);

(c) the process of assembly results in a change in the presentation of the authorised medicinal product; and

(d) by reason of that change the product so assembled is not sold or supplied in accordance with the terms of—

(i) the UK marketing authorisation,

(ia) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii) the certificate of registration,

(iii) the traditional herbal registration, or

(iv) the Article 126a authorisation,

that relates to the authorised medicinal product.

(13) The information specified in Part 1 of Schedule 26 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product that is sold or supplied in circumstances—

(a) where paragraph (11) applies to the product, except in the case of a product manufactured in accordance with paragraph (6); or

(b) where paragraph (12) applies in relation to the product.

(14) Regulations 269 (offences relating to packaging and package leaflets: other persons) and 271 (offences: penalties) shall have effect in relation to paragraph (13) as if that paragraph were a requirement of Part 13.

(15) For the purposes of this regulation and regulation 4 (special provisions for pharmacies etc ), a medicinal product is authorised if there is in force for the product—

(a) a UK marketing authorisation;

(aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) a certificate of registration;

(c) a traditional herbal registration; or

(d) an Article 126a authorisation.

Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products

3A.—(1) Regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) do not apply in circumstances where a medicinal product used for vaccination or immunisation against coronavirus is manufactured, prepared or assembled by or under the supervision of a doctor, a registered nurse or a pharmacist—

(a) who is acting in the course of his or her profession; and

(b) for the purposes of the supply or administration of the medicinal product to a patient under relevant arrangements.

(2) Regulation 46 does not apply in respect of a medicinal product—

(a) which is the result of the assembly of an authorisedmedicinal product;

(b) which is used for the reformulation of a medicinal product used for vaccination or immunisation against coronavirus; and

(c) the assembly of which (as mentioned in sub-paragraph (a)) is—

(i) in accordance with a manufacturer’s licence, or

(ii) undertaken in circumstances where regulation 17(1) does not apply by virtue of regulation 3 (scope of these regulations: special provisions) or regulation 4 (special provisions for pharmacies etc.).

(3) Regulation 17(1) does not apply in circumstances where a medicinal product used for vaccination or immunisation against coronavirus is labelled by a holder of a wholesale dealer’s licence to take account of a change to the shelf life of the product because of the thawing of the product.

(4) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products)—

(a) does not apply to a medicinal product that is the result of a process of manufacture, preparation or assembly in accordance with paragraph (1) or (2); and

(b) is to be construed as permitting labelling in accordance with paragraph (3), in the case of a product which is otherwise labelled in accordance with that Part.

(5) For the purposes of this regulation—

“authorised” has the meaning given in regulation 3(15); and

“relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence).

(6) This regulation ceases to have effect on 1st April 2026 .

Special provisions for pharmacies etc

4. —(1) Regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) do not apply where any provision of section 10 of the Medicines Act 1968 so provides.

(2) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products) does not apply to a medicinal product that is sold or supplied in circumstances where paragraph (3) or (4) applies in relation to the product, except to the extent set out in paragraph (6), but the requirements of paragraph (5) shall apply.

(3) This paragraph applies in a case where a medicinal product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968.

(4) This paragraph applies in the case of a medicinal product where—

(a) the product is the result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15);

(b) regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968;

(c) the process of assembly results in a change in the presentation of the authorised medicinal product; and

(d) by reason of that change the product so assembled is not sold or supplied in accordance with the terms of—

(i) the UK marketing authorisation,

(ia) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii) the certificate of registration,

(iii) the traditional herbal registration, or

(iv) the Article 126a authorisation,

that relates to the authorised medicinal product.

(5) The information specified in Part 2 of Schedule 26 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product that is sold or supplied in circumstances where paragraph (3) or (4) applies in relation to the product.

(6) Regulations 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons) and 271 (offences: penalties) shall have effect in relation to paragraph (5) as if that paragraph were a requirement of Part 13.

Classification of medicinal products

5. —(1) In these Regulations references to a medicinal product subject to general sale are to a product that is not a prescription only medicine or a pharmacy medicine but is—

(a) a product that is covered by an authorisation of which it is a term that the product is to be available on general sale .

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) In paragraphs (1)(a) and (5)(a) “ authorisation ” means—

(a) a UK marketing authorisation;

(b) a certificate of registration;

(c) a traditional herbal registration; or

(d) in the case of a medicinal product for sale or supply in Northern Ireland, an Article 126a authorisation.

(3) In these Regulations references to a prescription only medicine are to any of the following—

(a) a medicinal product that is covered by an authorisation of which it is a term that the product is to be available only on prescription;

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) a medicinal product that is a prescription only medicine by virtue of Part 1 of Schedule 1; or

(d) a medicinal product that is the result of—

(i) the assembly, or

(ii) the reformulation (including the combining with other substances),

of a medicinal product that is a prescription only medicine by virtue of sub-paragraph (a) ....

(4) In paragraph (3)(a) “ authorisation ” means—

(a) a UK marketing authorisation; or

(b) in the case of a medicinal product for sale or supply in Northern Ireland (that is not a listed NIMAR product) , an Article 126a authorisation.

(5) In these Regulations references to a pharmacy medicine are to a medicinal product that is not a prescription only medicinal product or a medicinal product subject to general sale but is—

(a) covered by an authorisation of which it is a term that the product is to be available only from a pharmacy;

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) available only from a pharmacy by virtue of Part 2 of Schedule 1; or

(d) the result of—

(i) the assembly, or

(ii) the reformulation (including the combining with other substances),

of a medicinal product that is a pharmacy medicine by virtue of sub-paragraph (a) ....

The licensing authority and the Ministers

6. —(1) The licensing authority is responsible for the grant, renewal, variation, suspension and revocation of licences, authorisations, certificates , designations, opinions and registrations under these Regulations.

(2) In these Regulations “ the licensing authority ” means either or both of the Ministers.

(3) Any function that—

(a) is conferred on “the licensing authority” by these Regulations; or

(b) is a function within paragraph (4),

may be exercised by either of the Ministers acting alone or by both of them acting jointly.

(4) The functions of a member State, or of the competent authority of a member State, under any of the relevant EU provisions are to be exercised by the licensing authority if—

(a) they relate to medicinal products; and

(b) they are to be exercised by, or by any authority of, the United Kingdom.

(5) Paragraph (4) does not apply to any function that is conferred by these Regulations on a person or body other than the licensing authority.

(6) In these Regulations “ the Ministers ” means—

(a) the Secretary of State; and

(b) the Minister for Health, Social Services and Public Safety.

(7) Any function that is conferred on “the Ministers” by these Regulations is to be exercised by the Ministers acting jointly.

(8) Paragraph (7) does not apply where these Regulations provide for a function of the Ministers to be exercised by either of them acting alone or both of them acting jointly.

Advertisements relating to medicinal products

7. —(1) In these regulations “ advertisement ”, in relation to a medicinal product, includes anything designed to promote the prescription, supply, sale or use of that product.

(2) This includes, in particular, the following activities—

(a) door-to-door canvassing;

(b) visits by medical sales representatives to persons qualified to prescribe or supply medicinal products;

(c) the supply of samples;

(d) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except where the intrinsic value of such inducements is minimal;

(e) the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and

(f) the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, including the payment of their travelling and accommodation expenses in that connection.

(3) But references in these Regulations to an “advertisement” do not include any of the following—

(a) a medicinal product's package or package leaflet;

(b) reference material and announcements of a factual and informative nature, including—

(i) material relating to changes to a medicinal product's package or package leaflet,

(ii) adverse reaction warnings,

(iii) trade catalogues, and

(iv) price lists,

provided that no product claim is made; or

(c) correspondence, which may be accompanied by material of a non-promotional nature, answering a specific question about a medicinal product.

(d) In this regulation “ person qualified to prescribe or supply medicinal products ” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

General interpretation

8. —(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”—

“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—

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—

“ 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—

...

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

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

“ 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—

“ 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—

“ 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—

“ 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;

“ doctor ” means a registered medical practitioner;

“ EAMS medicinal product ” means a medicinal product that—

“ 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)—

“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—

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

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

“ the Good Manufacturing Practice Directive ” means —

“ 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—

“ health centre ” means a health centre maintained under—

...

“ 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—

“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—

“ 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);

“ marketing authorisation ” means—

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

“medical device”—

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

“ naloxone product ” means a medicinal product that contains naloxone or a salt, ester or stereoisomeric form of naloxone;

“ name ” in relation to a medicinal product means—

“ the Narcotic Drugs Convention ” means the Single Convention on Narcotic Drugs signed by the United Kingdom on 30th March 1961 as amended by the Protocol Amending the Single Convention on Narcotic Drugs signed by the United Kingdom on 25th March 1972;

“ NHS primary dental services ” means—

“ NHS primary medical services ” means—

“ NIMAR ” means Northern Ireland MHRA authorised route;

“ nurse independent prescriber ” means a person who—

“nursing home” has the meaning given by article 11 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003;

“ occupational health vaccinator ” means a person who is employed or engaged by a person operating an occupational health scheme, who is—

“ optometrist independent prescriber ” means a person—

“ orphan criteria ” means the criteria listed in regulation 50G(2);

“ orphan marketing authorisation ” means a UK marketing authorisation granted under regulation 49(1)(a) in accordance with regulation 58C;

“ Orphan Regulation ” means Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products as it has effect in EU law;

“ outer packaging ” in relation to a medicinal product means any packaging into which the immediate packaging of the medicinal product is placed;

“ package ” in relation to a medicinal product, includes—

“ package leaflet ” in relation to a medicinal product, means a leaflet that accompanies the product and contains information for the user of the product;

“ paediatric clinical trial ” means a clinical trial conducted in whole or in part on persons under the age of 18 years;

“ paediatric indication ” means a term of a UK marketing authorisation enabling the medicinal product to which the authorisation relates to be used by or administered to persons under the age of 18 years;

“ paediatric investigation plan ” means a research and development programme with the purpose of generating data determining the conditions in which a medicinal product may be authorised to treat persons under the age of 18 years;

“ paediatric population ” means that part of the population consisting of persons under the age of 18 years;

“ the Paediatric Regulation ” means Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92 , Directive 2001/20/EC , Directive 2001/83/EC and Regulation (EC) No 726/2004 ;

“parallel import licence” has the meaning given in regulation 48(2);

“paramedic independent prescriber” means a person—

“periodic safety update report” or “ PSUR ” has the meaning given in regulation 191 (obligation on holder to submit periodic safety update reports: general requirements);

“ pharmacist ” means—

“ pharmacist independent prescriber ” means a person who—

“ the Pharmacovigilance Risk Assessment Committee ” means the committee of the EMA established by Article 56(1)(aa) of Regulation (EC) No 726/2004 ;

“ pharmacovigilance system ” means a system used by the holder of a UK marketing authorisation ... , traditional herbal registration or Article 126a authorisation, or by the licensing authority, to fulfil the tasks and responsibilities set out in Part 11 and designed to monitor the safety of authorised or registeredmedicinal products and detect any change to their risk-benefit balance;

“ pharmacovigilance system master file ” means a detailed description of the pharmacovigilance system used by the holder of a UK marketing authorisation ... , traditional herbal registration or Article 126a authorisation with respect to one or more authorised or registeredmedicinal products;

“ pharmacy medicine ” has the meaning given in regulation 5(5) (classification of medicinal products);

“physiotherapist independent prescriber” means a person—

“podiatrist independent prescriber” means a person—

“ post-authorisation efficacy study ” means any study relating to a medicinal product to which a UK marketing authorisation relates that is conducted with the aim of considering the efficacy of that product;

“ post-authorisation safety study ” means any study relating to a medicinal product to which a UK marketing authorisation ... , traditional herbal registration or Article 126a authorisation relates that is conducted with the aim of—

“ prescription only medicine ” has the meaning given in regulation 5(3) (classification of medicinal products);

“ product information ” in relation to a medicinal product means—

“ the professional register ” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001 ;

“provider of probation services”—

“ provider of youth justice services ” means—

“ the Psychotropic Substances Convention ” means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971;

“qualified person”, except in relation to the expression “appropriately qualified person”, means—

“qualifying Northern Ireland goods” has the same meaning that it has in the European Union (Withdrawal) Act 2018, including any meaning defined for the purposes of that Act from time to time by regulations made under the power conferred by section 8C(6) of that Act;

“radiation emergency” has the meaning given by regulation 2(1) of the Radiation (Emergency Preparedness and Public Information) Regulations 2019 ;

“ radionuclide ” means a radioactive isotope;

“ radionuclide generator ” means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and is to be used in a radiopharmaceutical;

“ radionuclide kit ” means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration;

“ radionuclide precursor ” means any radionuclide produced for the radio-labelling of another substance prior to administration, other than a radionuclide that is incorporated in or produced from a generator or is included in a radiopharmaceutical;

“ radiopharmaceutical ” means a medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose;

“registered dietitian” means a person registered in Part 4 of the Health and Care Professions Council register;

“ registered midwife ” means a person registered in the Midwives Part of the professional register;

“ registered nurse ” means a person registered in the Nurses Part or the Specialist Community Public Health Nurses Part of the professional register;

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

“registered paramedic” means a person who is registered in Part 8 of the Health and Care Professions Council register;

“ registered pharmacy ” means—

“registered physiotherapist” means a person registered in Part 9 of the Health and Care Professions Council register;

“registered podiatrist” means a person registered in Part 2 of the Health and Care Professions Council register;

“registered radiographer” means a person registered in Part 11 of the Health and Care Professions Council register;

“ registrable homoeopathic medicinal product ” means a homoeopathic medicinal product to which regulation 102 applies;

“Regulation (EC) No 726/2004 ” means Regulation ( EC ) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency , as it has effect in EU law ;

...

“ Regulation (EC) No 1234/2008 ” means Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products , as it has effect in EU law ;

“ the relevant EU provisions ” means the provisions of legislation of the European Union relating to medicinal products for human use, except to the extent that any other enactment provides for any function in relation to any such provision to be exercised otherwise than by the licensing authority;

“ relevant European State ” means an EEA State or Switzerland;

“ relevant medicinal product ” has the meaning given by regulation 48;

“ the relevant register ” means—

“ retail pharmacy business ” means a business (other than a professional practice carried on by a doctor or dentist) which consists of or includes the retail sale of medicinal products that are not subject to general sale;

“ risk management plan ” means a detailed description of the risk management system;

“ risk management system ” means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including an assessment of the effectiveness of those activities and interventions;

“ serious adverse reaction ” means an adverse reaction that—

“ special medicinal product ” means a product within the meaning of regulation 167 or any equivalent legislation in a country other than the United Kingdom;

“ substance ” means any matter regardless of its origins and includes—

“ the summary of the product characteristics ” in relation to a medicinal product means—

“ supplementary prescriber ” means a person who is noted in the relevant register as qualified to order drugs, medicines and appliances as a supplementary prescriber (or, in the case of a registered nurse or registered midwife, as a nurse independent/supplementary prescriber) and is—

“ supplementary protection certificate ” has the meaning given in section 128B(2) of the Patents Act 1977;

“ suspected ” in relation to an adverse reaction means that there is at least a reasonable possibility of there being a causal relationship between a medicinal product and an adverse event;

“therapeutic radiographer independent prescriber” means a person—

...

“ traditional herbal medicinal product ” means a herbal medicinal product to which regulation 125 applies;

“ traditional herbal registration ” means a traditional herbal registration granted by the licensing authority under these Regulations and—

“ UK marketing authorisation ” means a marketing authorisation granted by the licensing authority under Part 5 of these Regulations or Chapter 4 of Title III to the 2001 Directive (mutual recognition and decentralised procedure) and—

“ UKMA(UK)(Category 1) ” means a marketing authorisation of the description in regulation 49(1ZB);

“ UKMA(UK)(Category 2) ” means a marketing authorisation of the description in regulation 49(1ZC);

“under the unfettered access route” means an application for—

“ vaccine ” means an antigenic substance which consists wholly or partly of—

being substances which, when administered to human beings, are used for the prevention of specific diseases;

“ variation to the terms of a UK marketing authorisation ” means any change to—

and “vary” and “ variation ” in relation to a UK marketing authorisation are to be construed accordingly;.

“withdrawal agreement” has the meaning given in section 39 of the European Union (Withdrawal Agreement) Act 2020;

“ wholesale dealer's licence ” has the meaning given by regulation 18(1).

(2) In these Regulations, references to distribution of a product by way of wholesale dealing are to be construed in accordance with regulation 18(4) and (5) .

(3) In these Regulations, references to selling by retail, or to retail sale, are references to selling a product to a person who buys it otherwise than for a purpose specified in regulation 18(5) .

(4) In these Regulations, references to supplying anything in circumstances corresponding to retail sale are references to supplying it, otherwise than by way of sale, to a person who receives it otherwise than for a purpose specified in regulation 18(5) ;

(5) References in these Regulations to the terms of—

(a) a UK marketing authorisation include the information supplied in relation to the authorisation in accordance with—

(i) regulation 50 and Schedule 8, and

(ii) (if appropriate) Schedule 10 (national homoeopathic products),

as updated in accordance with regulation 57, as approved upon grant under regulation 49 and as varied under regulation 68;

(b) a certificate of registration include the information supplied in relation to the certificate in accordance with regulation 103, as approved upon grant under regulation 103 and as varied under regulation 110; and

(c) a traditional herbal registration include the information supplied in relation to the registration in accordance with regulation 128 and Schedule 12, as updated in accordance with regulation 129, as approved upon grant under regulation 127 and as varied under regulation 135.

(6) References in these Regulations to a condition of—

(a) a UK marketing authorisation is to a condition to which the authorisation is subject by virtue of regulation 59(1) , 60(1) or 60A ; and

(b) a certificate of registration is to a condition to which the certificate is subject by virtue of regulation 105(1).

(7) For the purposes of these Regulations medicinal products are of the same description if—

(a) they are manufactured to the same specification, and

(b) they are in the same pharmaceutical form.

(8) Subject to regulation C17(6), references in these Regulations to—

(a) good manufacturing practice for active substances relate to the principles and guidelines for good manufacturing practice adopted by the European Commission under the third paragraph of Article 47 of the 2001 Directive;

(b) good distribution practice for active substances relate to the guidelines on good distribution practices for active substances adopted by the European Commission under the fourth paragraph of Article 47 of the 2001 Directive.

(9) Unless otherwise provided, any provision of an EU Regulation made applicable to a UKMA(NI), COR(NI) or THR(NI) by virtue of Article 5(4) of, and Annex 2 to, the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement applies equally in respect of a UKMA(UK)(Category 2) , COR(UK) or THR(UK).

PART 2 Administration

Commission on Human Medicines

9. —(1) There is to continue to be a body known as the Commission on Human Medicines (referred to in these Regulations as “ the Commission ”).

(2) The Commission is to perform the functions conferred on it by these Regulations.

(3) The Commission is to have at least eight members.

(4) The members of the Commission are to be appointed by the Ministers.

(5) The Ministers must appoint one of the members of the Commission to chair it.

(6) The Ministers must consult the Scottish Ministers before exercising their functions under paragraphs (4) and (5).

Functions of the Commission

10. —(1) The Commission must give advice to either or both of the Ministers in relation to the matters listed in paragraph (2) if—

(a) the Minister, or Ministers, request it; or

(b) the Commission considers it appropriate to give it.

(2) The matters mentioned in paragraph (1) are matters—

(a) relating to the execution of any duty imposed by these Regulations or the Clinical Trials Regulations;

(b) relating to the exercise of any power conferred by these Regulations or the Clinical Trials Regulations; or

(c) otherwise relating to medicinal products.

(3) Without prejudice to paragraphs (1) and (2), or to any other functions conferred on the Commission by or under these Regulations, the Commission must—

(a) give advice with respect to the safety, quality and efficacy of medicinal products; and

(b) promote the collection and investigation of information relating to adverse reactions, for the purposes of enabling such advice to be given.

(4) The Commission must also advise the licensing authority if—

(a) the licensing authority is required under Schedule 11 (advice and representations) or the Clinical Trials Regulations to consult the Commission about any matter arising under those provisions; or

(b) the licensing authority consults the Commission about any matter arising under those provisions.

British Pharmacopoeia Commission

11. —(1) There is to continue to be a committee called the British PharmacopoeiaCommission (referred to as “ the BPC ” in this regulation).

(2) The BPC is to continue to have the following functions—

(a) the preparation under regulation 317(1) of editions of the British Pharmacopoeia;

(b) the preparation of compendia under regulation 317(3);

(c) the preparation under regulation 318 (which provides for the preparation and publication of lists of names to be used as headings to monographs in the British Pharmacopoeia) of lists of names; and

(d) the preparation of any other document under regulation 319.

(3) The BPC is to have at least eight members.

(4) The members of the BPC are to be appointed by the Ministers.

(5) The Ministers must appoint one of the members of the BPC to chair it.

(6) The Ministers must consult the Scottish Ministers before exercising their functions under paragraphs (4) and (5).

(7) In this regulation, a reference to preparation includes revision or amendment.

Reporting to Ministers

12. —(1) In this Part “ advisory body ” means—

(a) the Commission, or

(b) the British PharmacopoeiaCommission.

(2) Each advisory body must give a report to the Ministers each year about—

(a) the performance of its functions; and

(b) the performance of the functions of any expert advisory group appointed by it under regulation 14 (including any expert advisory group appointed jointly with the other advisory body).

(3) Each advisory body must give its report to the Ministers at the time specified by the Ministers.

(4) The Secretary of State must lay a copy of each report before Parliament.

Co-option of additional members of advisory bodies

13. —(1) An advisory body may co-opt one or more additional members for the purposes of a meeting.

(2) A person co-opted as a member of an advisory body for the purposes of a meeting ceases to be a member at the end of the meeting.

Appointment of expert advisory groups

14. —(1) An advisory body, or the advisory bodies acting jointly, may with the approval of the licensing authority appoint one or more sub-committees, to be known as expert advisory groups.

(2) The licensing authority may direct an advisory body to appoint an expert advisory group to advise on the matters specified in the direction.

(3) An expert advisory group may include, or consist of, persons who are not members of the advisory body or bodies which appointed the expert advisory group.

(4) The advisory body or bodies which appointed the expert advisory group must appoint a member of the group as its chair.

(5) The chair of an expert advisory group may co-opt additional members of the group for the purposes of a meeting.

(6) Before co-opting additional members under paragraph (5) the chair of the group must consult the chair of the advisory body or bodies which appointed the group.

(7) A person co-opted as a member of an expert advisory group for the purposes of a meeting ceases to be a member of the group at the end of the meeting.

Delegation of functions to expert advisory groups

15. —(1) An advisory body may delegate any of its functions, other than the functions specified in paragraph (2), to an expert advisory group.

(2) The functions which may not be delegated are functions of providing advice to the licensing authority in any case where the licensing authority is required to consult the advisory body under—

(a) Schedule 11 (advice and representations); and

(b) the Clinical Trials Regulations.

(3) But an advisory body may arrange for an expert advisory group to provide advice to the advisory body in relation to the performance of a function referred to in paragraph (2).

Further provision about advisory bodies and expert advisory groups etc

16.Schedule 2 (which makes further provision about advisory bodies and expert advisory groups, and provision about payment and expenses of expert committees appointed by the licensing authority) has effect.

PART 3 Manufacture and distribution of medicinal products and active substances

CHAPTER 1 Interpretation

Interpretation

A17. In this Part “manufacture”, in relation to an active substance, includes any process carried out in the course of making the substance and the various processes of dividing up, packaging, and presentation of the active substance.

Chapter 1A Good manufacturing practice and good distribution practice

Regulations on good manufacturing practice

B17.—(1) The Secretary of State may by regulations in respect of Great Britain set out principles and guidelines of good manufacturing practice in respect of medicinal products and investigational medicinal products.

(2) Regulations under paragraph (1) may in particular make provisions as to—

(a) inspections;

(b) compliance with good manufacturing practice and, where relevant, the UK marketing authorisation ... ;

(c) quality assurance systems;

(d) personnel;

(e) premises and equipment;

(f) documentation;

(g) production;

(h) quality control;

(i) the contracting out of work;

(j) complaints and product recall;

(k) self-inspection.

(3) Subject to any provision made in regulations under paragraph (1), the principles and guidelines set out in the Good Manufacturing Practice Directive have effect in Great Britain on and after IP completion day as they had effect immediately before IP completion day, but subject to the modifications specified in Schedule 2A.

(4) The Secretary of State may by regulations in respect of Great Britain amend or revoke Schedule 2A.

Guidelines on good manufacturing practice and good distribution practice

C17.—(1) The licensing authority may publish in relation to the manufacture or assembly of a medicinal product in, or import to, the United Kingdom —

(a) detailed guidelines of good manufacturing practice in respect of medicinal products, and investigational medicinal products, referred to in Article 46(f) of the 2001 Directive, including guidelines as to the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients;

(b) principles and guidelines of good manufacturing practice for active substances, referred to in the first paragraph of point (f) of Article 46 and in Article 46b of that Directive;

(c) principles and guidelines of good distribution practice referred to in the first paragraph of point (f) of Article 46, and Article 84, of that Directive.

(2) Guidelines or principles under paragraph (1) may replace, amend or otherwise modify any guidelines or principles published or adopted by the European Commission under the second, third, fourth or fifth paragraph of Article 47, or Article 84, of the 2001 Directive.

(3) Unless replaced by principles or guidelines published under paragraph (1), principles and guidelines published or adopted by the European Commission under the second, third, fourth or fifth paragraph of Article 47, or Article 84, of the 2001 Directive, as they applied immediately before IP completion day, continue to apply on and after IP completion day (subject to any amendments or modifications published under paragraph (1)).

(4) Before exercising the power under paragraph (1), the licensing authority must consult such persons as it considers appropriate.

(5) The licensing authority may only exercise its power under paragraph (1) if it considers that it is necessary in order to take account of technical or scientific progress.

(6) If the licensing authority publishes principles and guidelines under paragraph (1), any reference in these Regulations to any principle or guideline adopted under the provisions of the 2001 Directive specified in those paragraphs is instead to be read as a reference to the principle or guideline published under paragraph (1), or that principle or guideline as amended or modified (as the case may be).

CHAPTER 2 Manufacturing and wholesale dealing

Grant etc of licences

Manufacturing of medicinal products

17.—(1) A person may not except in accordance with a licence (a “manufacturer's licence”)—

(a) manufacture a medicinal product,

(b) assemble a medicinal product,

(c) import a medicinal product into Great Britain from a country other than—

(i) Northern Ireland, or

(ii) an approved country for import,

(d) import a medicinal product into Northern Ireland from a country other than an EEA State, or

(e) possess a medicinal product for the purpose of any activity in sub-paragraphs (a) to (d).

(2) Paragraph (1) is subject to paragraphs (3) to (9) .

(3) Paragraph (1) applies in relation to an investigational medicinal product only—

(a) if the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration; and

(b) to the extent that the manufacture or assembly of the product is in accordance with the terms and conditions of that authorisation, certificate or registration.

(4) In paragraph (3), “ marketing authorisation ” means—

(a) a marketing authorisation issued by a competent authority in accordance with the 2001 Directive; ...

(aa) a UK marketing authorisation; or

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) Paragraph (1) does not apply to a person who, in connection with the importation of a medicinal product ...—

(a) provides facilities solely for transporting the product; or

(b) acting as an import agent, imports the medicinal product solely to the order of another person who holds a manufacturer's licence authorising the importation of the product.

(6) Paragraph (1) does not apply to a person who imports a medicinal product for administration to himself or herself or to any other person who is a member of that person's household.

(7) Paragraph (1) does not apply to imports into Northern Ireland from Great Britain of—

(a) special medicinal products, ...

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) For the purposes of paragraph (7) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.

(9) Paragraph (1)(d) does not apply to the importation of a medicinal product into Northern Ireland from Great Britain by the holder of a wholesale dealer’s licence, where the following conditions are met—

(a) the medicinal product has undergone—

(i) in an EEA State, the quality control testing provided for by Article 51 of the 2001 Directive, or

(ii) in the United Kingdom, checks in accordance with these Regulations and the requirements of the marketing authorisation relating to the product and that these are appropriately certified;

(b) the batch release of the medicinal product has been undertaken—

(i) in Northern Ireland or an EEA State, by a qualified person in accordance with Article 51(1) of the 2001 Directive, and it is accompanied by the appropriate control reports, or

(ii) in Great Britain, by a qualified person applying equivalent standards;

(c) the medicinal product has a UKMA(UK) or UKMA(NI); and

(d) the importation of the medicinal product is with a view to its sale or supply in Northern Ireland only; ...

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealing in medicinal products

18.—(1) A person may not except in accordance with a licence (a “wholesale dealer’s licence”)—

(a) distribute a medicinal product by way of wholesale dealing; ...

(b) possess a medicinal product for the purpose of such distribution; ...

(c) import a medicinal product into Great Britain from an approved country for import ; or

(d) supply a listed NIMAR product from Great Britain to Northern Ireland.

(2) Paragraph (1)—

(a) does not apply—

(i) to anything done in relation to a medicinal product by the holder of a manufacturer’s licence in respect of that product,

(ii) where the product concerned is an investigational medicinal product, or

(iii) if the product is a radiopharmaceutical in which the radionuclide is in the form of a sealed source; and

(b) is subject to regulation 19.

(2A) Paragraph (1)(c) does not apply to imports into Great Britain from an EEA State of medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day.

(2B) For the purposes of paragraph (2A) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.

(3) Distribution of a medicinal product by way of wholesale dealing, or possession for the purpose of such distribution, is not to be taken to be in accordance with a wholesale dealer’s licence unless the distribution is carried on, or as the case may be the product held, at premises located in the UK and specified in the licence.

(4) In these Regulations a reference to distributing a product (including a listed NIMAR product) by way of wholesale dealing is a reference to—

(a) selling or supplying it; or

(b) procuring or holding it or exporting it for the purposes of sale or supply,

to a person who receives it for a purpose within paragraph (5).

(5) Those purposes are—

(a) selling or supplying the product; or

(b) administering it or causing it to be administered to one or more human beings,

in the course of a business carried on by that person.

(6) A wholesale dealer’s licence does not authorise the distribution of a medicinal product by way of wholesale dealing, or possession of a medicinal product for the purpose of such distribution, unless—

(a) in the case of a product for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration is in force in respect of the product, ...

(b) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK) ..., Article 126a authorisation, certificate of registration or traditional herbal registration is in force in respect of the product, or

(c) in the case of a listed NIMAR product, a UKMA(GB) or UKMA(UK) is in force in respect of the product,

but this is subject to the exceptions in regulation 43(6).

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Approved country for import

18A.—(1) The licensing authority must—

(a) publish a list of countries from which medicinal products may be imported under a wholesale dealing licence (“approved country for import list”); and

(b) only include in that list a country which is included in the approved country for batch testing list.

(2) In order to determine whether a country should be included in the approved country for import list, the licensing authority may, in particular, take into account—

(a) the country's system for ensuring that each batch of a medicinal product has been manufactured and checked in accordance with the requirements of its legislation and any authorisation in respect of that product;

(b) the country's rules for good distribution practice;

(c) the regularity of inspections to verify compliance with good distribution practice;

(d) the effectiveness of enforcement of good distribution practice;

(e) the regularity and rapidity of information provided by that country relating to non-compliant manufacturers and distributers of medicinal products;

(f) any on-site review of that country's regulatory system undertaken by the licensing authority;

(g) any on-site inspection of a manufacturing site in that country observed by the licensing authority; and

(h) any other relevant documentation available to the licensing authority.

(3) The licensing authority must—

(a) remove a country from the approved country for import list if that country is removed from the approved country for batch testing list;

(b) in any event review the countries it has included in the approved country for import list to determine if it is still satisfied that the country should remain on that list, and if it is not so satisfied, remove that country from the list; and

(c) undertake that review at least every three years beginning with the date on which that country is included in that list.

Exemptions from requirement for wholesale dealer's licence

19. —(1) Regulation 18 does not apply to the sale or offer for sale of a medicinal product by way of wholesale dealing, or possession for the purpose of such sale or offer, where paragraph (2) applies and the person selling or offering the product for sale is—

(a) the holder of—

(i) in the case of a product for sale or supply in Great Britain (including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland) , a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”) which relates to the product, or

(ii) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK) ... or an Article 126a authorisation (an “authorisation”) which relates to the product,

including a holder of an authorisation who manufactured or assembled the product; or

(b) a person who is not the holder of an authorisation in relation to the product but manufactured or assembled the product in the United Kingdom to the order of a person who is the holder of an authorisation relating to the product.

(2) This paragraph applies if—

(a) until the sale, the medicinal product has been kept on the premises of the person who manufactured or assembled the product (in this regulation referred to as “ authorised premises ”); and

(b) those premises are premises authorised for use for manufacture or assembly by that person's manufacturer's licence.

(3) For the purposes of this regulation, a medicinal product is regarded as having been kept on authorised premises at a time when—

(a) it was being moved from one set of authorised premises to another, or from one part of authorised premises to another part; or

(b) it was being moved from authorised premises by way of delivery to a purchaser.

(4) Regulation 18 does not apply to a person who in connection with the importation of a medicinal product—

(a) provides facilities solely for transporting the product; or

(b) acting as an import agent, handles the product where the product is imported solely to the order of another person who intends to sell the product or offer it for sale by way of wholesale dealing or to distribute it in any other way.

(4A) Regulation 18 does not apply in connection with the distribution by way of wholesale dealing of a medicinal product to be used for vaccination or immunisation against coronavirus or influenza virus, where the person distributing the medicinal product—

(a) was supplied with the medicinal product for the purposes of the administration of it under relevant arrangements;

(b) is supplying the medicinal product for the purposes of the administration of it by the person to whom it is being supplied (or by a person employed or engaged by them) under relevant arrangements; and

(c) is authorised by the body making the arrangements to supply the medicinal product as mentioned in sub-paragraph (b) under the relevant arrangements.

(4B) Regulation 18 does not apply in connection with the distribution by way of wholesale dealing of a medicinal product to be supplied or administered in accordance with a protocol of the type mentioned in regulation 247, where the person distributing the medicinal product—

(a) was supplied with the medicinal product for the purposes of the supply or administration of it to a patient under relevant arrangements;

(b) is supplying the medicinal product for the purposes of the supply or administration of it to a patient by the person to whom it is being supplied (or by a person employed or engaged by them) under relevant arrangements; and

(c) is authorised by the body making the arrangements to supply the medicinal product as mentioned in sub-paragraph (b) under the relevant arrangements.

(4C) In this regulation, “relevant arrangements” means—

(a) arrangements for the provision of services as part of—

(i) in England, the health service as defined by section 275(1) of the National Health Service Act 2006,

(ii) in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 1978,

(iii) in Wales, the health service as defined by section 206(1) of the National Health Service (Wales) Act 2006, and

(iv) in Northern Ireland, the system of health and social care promoted under section 2(1) of the Health and Social Care (Reform) Act (Northern Ireland) 2009; or

(b) arrangements for the provision of services (otherwise than as mentioned in sub-paragraph (a)) as part of the medical services of Her Majesty’s Forces.

(4D) Paragraphs (4A) to (4C) cease to have effect on 1st April 2026 .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) Regulation 18 does not apply to a person (“P”) who imports a medicinal product into Great Britain from an approved country for import for administration to P or to any other person who is a member of P’s household.

Mixing of medicines

20. —(1)Regulation 17(1) (manufacturing of medicinal products) does not apply to the mixing of medicines by—

(a) a nurse independent prescriber;

(b) a pharmacist independent prescriber;

(c) a supplementary prescriber, if the mixing of medicines forms part of the clinical management plan for an individual patient;

(ca) physiotherapist independent prescriber;

(cb) podiatrist independent prescriber;

(cc) a therapeutic radiographer independent prescriber;

(cd) a paramedic independent prescriber;

(d) a person acting in accordance with the written directions of a—

(i) doctor,

(ii) dentist,

(iii) nurse independent prescriber, ...

(iv) pharmacist independent prescriber,

(v) physiotherapist independent prescriber, ...

(vi) podiatrist independent prescriber; or

(vii) therapeutic radiographer independent prescriber; or

(viii) paramedic independent prescriber; or

(e) a person acting in accordance with the written directions of a supplementary prescriber, if the mixing of medicines forms part of the clinical management plan for an individual patient.

(2) In this regulation “ mixing of medicines ” means the combining of two or more medicinal products together for the purposes of administering them to meet the needs of an individual patient.

Application for manufacturer's or wholesale dealer's licence

21. —(1) An application for a grant of a licence under this Part must—

(a) be made to the licensing authority;

(b) be made in the way and form specified in Schedule 3; and

(c) contain or be accompanied by the information, documents, samples and other material specified in that Schedule.

(2) An application must indicate the descriptions of medicinal products in respect of which the licence is required, either by specifying the descriptions of medicinal products in question or by way of an appropriate general classification.

Factors relevant to determination of application for manufacturer's or wholesale dealer's licence

22. —(1) In dealing with an application for a manufacturer's licence the licensing authority must in particular take into consideration—

(a) the operations proposed to be carried out under the licence;

(b) the premises in which those operations are to be carried out;

(c) the equipment which is or will be available on those premises for carrying out those operations;

(d) the qualifications of the persons under whose supervision the operations will be carried out; and

(e) the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products manufactured or assembled in pursuance of the licence.

(2) In dealing with an application for a wholesale dealer's licence the licensing authority must in particular take into consideration—

(a) the premises on which medicinal products of the descriptions to which the application relates will be stored;

(b) the equipment which is or will be available for storing medicinal products on those premises;

(c) the equipment and facilities which are or will be available for distributing medicinal products from those premises; and

(d) the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products stored on or distributed from those premises.

Grant or refusal of licence

23. —(1) Subject to the following provisions of these Regulations, on an application to the licensing authority for a licence under this Part the licensing authority may—

(a) grant a licence containing such provisions as it considers appropriate; or

(b) refuse to grant a licence if having regard to the provisions of these Regulations ... it considers it necessary or appropriate to do so.

(2) The licensing authority must grant or refuse an application for a licence under this Part within the period of 90 days beginning immediately after the day on which it receives the application.

(3) Paragraph (2) applies to an application only if the requirements of Schedule 3 have been met.

(4) If a notice under regulation 30 requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (2).

(5) In paragraph (4), the “ information period ” means the period—

(a) beginning with the day on which the notice is given, and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority's satisfaction that the applicant is unable to provide it.

(6) The licensing authority must give the applicant a notice stating the reasons for its decision in any case where—

(a) the licensing authority refuses to grant an application for a licence; or

(b) the licensing authority grants a licence otherwise than in accordance with the application and the applicant requests a statement of its reasons.

Standard provisions of licences

24. —(1) The standard provisions set out in Schedule 4 may be incorporated by the licensing authority in a licence under this Part granted on or after the date on which these Regulations come into force.

(2) The standard provisions may be incorporated in a licence with or without modifications and either generally or in relation to medicinal products of a particular class.

(3) In Schedule 4, in relation to a licence holder in Great Britain, references to the principles and guidelines set out in the Good Manufacturing Practice Directive are to those principles and guidelines as they apply under or by virtue of regulation B17.

Duration of licence

25. A licence granted under this Part remains in force until—

(a) the licence is revoked by the licensing authority; or

(b) the licence is surrendered by the holder.

General power to suspend, revoke or vary licences

26. —(1) The licensing authority may in accordance with the procedure specified in regulation 27—

(a) suspend a licence under this Part for such period as the authority thinks fit;

(b) revoke a licence under this Part; or

(c) vary the provisions of a licence under this Part.

(2) The suspension or revocation of a licence may be—

(a) total;

(b) limited to medicinal products of one or more descriptions; or

(c) limited to medicinal products manufactured, assembled or stored on specified premises or a specified part of any premises.

(3) The powers conferred by this regulation may not be exercised in relation to a manufacturer's licence or a wholesale dealer's licence except on one or more of the grounds specified in—

(a) paragraph (4) (in relation to either a manufacturer's licence or a wholesale dealer's licence);

(b) paragraph (5) (in relation to a manufacturer's licence); or

(c) paragraph (6) (in relation to a wholesale dealer's licence).

(4) Those grounds are that—

(a) the information in the application as a result of which the licence was granted was false or incomplete in a material respect;

(b) a material change of circumstances has occurred in relation to any of the matters stated in the application;

(c) the holder of the licence has materially contravened a provision of it; or

(d) the holder of the licence has without reasonable excuse failed to supply information to the licensing authority with respect to medicinal products of a description to which the licence relates when required to do so under regulation 30(2).

(5) In relation to a manufacturer's licence, the powers conferred by this regulation may also be exercised on either or both of the following grounds—

(a) that the holder of the manufacturer's licence has manufactured or assembled medicinal products to the order of a person who holds—

(i) in the case of a product for sale or supply in Great Britain, a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), ...

(ii) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI) or a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”), or

(iii) in the case of a listed NIMAR product, a UKMA(GB) or UKMA(UK) (an “authorisation”),

and has habitually failed to comply with the provisions of that authorisation; or

(b) that the holder of the manufacturer's licence does not have appropriate facilities to carry out processes of manufacture or assembly authorised by the licence.

(6) In relation to a wholesale dealer's licence, the powers conferred by this regulation may also be exercised on the grounds that the equipment and facilities available to the holder of the licence for storing or distributing medicinal products are inadequate to maintain the quality of medicinal products of one or more descriptions to which the licence relates.

Procedure where licensing authority proposes to suspend, revoke or vary licence

27. —(1) This regulation applies where—

(a) the provisions of regulation 28 do not apply; and

(b) the licensing authority proposes to suspend, vary or revoke a licence under regulation 26.

(2) The licensing authority must notify the licence holder in writing of—

(a) its proposal;

(b) the reasons for it; and

(c) the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, revocation or variation should take effect.

(3) The licence holder may before the date specified in the notice—

(a) make written representations to the licensing authority with respect to the proposal; or

(b) notify the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations.

(4) If the licence holder makes written representations in accordance with paragraph 3(a) the licensing authority must take those representations into account before making a decision in the matter.

(5) If the licence holder notifies the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations in accordance with paragraph (3)(b)—

(a) Schedule 5 has effect; and

(b) the licence holder must pay a fee for a review upon oral representations in accordance with the Fees Regulations.

(6) If the licensing authority proceeds to suspend, revoke or vary a licence in accordance with the provisions of regulation 26 it must give a notice to the licence holder.

(7) The notice must—

(a) give particulars of the suspension, revocation or variation; and

(b) give reasons for the decision to suspend, revoke or vary the licence.

(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

Suspension of licence in cases of urgency

28. —(1) Notwithstanding anything in the preceding provisions of this Part, where it appears to the licensing authority that in the interests of safety it is necessary to suspend a licence under this Part with immediate effect, the licensing authority may do so for a period not exceeding three months.

(2) This paragraph applies where—

(a) a licence has been suspended under paragraph (1); and

(b) it appears to the licensing authority that it is necessary to consider whether the licence should be further suspended, revoked or varied.

(3) Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 27 (but this is subject to paragraphs (4) and (5)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 27 and any proceedings under that regulation have not been finally disposed of before the end of the period for which the licence was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the licence for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 27 to suspend, vary or revoke the licence is made on an application to the High Court under regulation 322(4) paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a).

Variation of licence on the application of the holder

29. —(1) This regulation applies if the holder of a licence under this Part applies to the licensing authority for a variation of the licence.

(2) The application must—

(a) be in writing;

(b) specify the variation requested;

(c) be signed by or on behalf of the applicant;

(d) be accompanied by such information as may be required to enable the licensing authority to consider the application; and

(e) be accompanied by the required fee (if any).

(3) The licensing authority must consider an application made in accordance with this regulation.

(4) If paragraph (5) applies, the licensing authority must vary the licence or refuse to vary it before the end of the period allowed for considering the application.

(5) This paragraph applies to a variation which would have the effect of altering—

(a) the types of medicinal product in respect of which the licence was granted;

(b) any operation carried out under the licence; ...

(c) any premises, equipment or facilities in respect of which the licence was granted; or

(d) the responsible person (import) under regulation 45AA.

(6) The period allowed for consideration of an application under this regulation is—

(a) in a case where the licensing authority considers that it is necessary to inspect premises to which the licence relates, 90 days beginning with the day after the date when the licensing authority receives the application; and

(b) in any other case 30 days beginning with that day.

(7) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application.

(8) If a notice under paragraph (7) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (6).

(9) In paragraph (8), the “ information period ” means the period—

(a) beginning with the day on which the notice is given; and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority's satisfaction that the applicant is unable to provide it.

(10) Nothing in this regulation affects the powers conferred by regulation 26.

Provision of information

30. —(1) Where an application has been made to the licensing authority for a licence under this Part, the licensing authority may, before determining the application, require the applicant to provide such information as the licensing authority thinks necessary, within the period specified by the licensing authority.

(2) The licensing authority may give a notice to the holder of a licence under this Part, requiring the holder to provide information of a kind specified in the notice within the period specified in the notice.

(3) A notice under paragraph (2) may not be given to the holder of a licence unless it appears to the licensing authority, or representations are made to the licensing authority by the Commission, an expert advisory group of the Commission, or an expert committee appointed by the licensing authority, that it is necessary for the licensing authority to consider whether the licence should be varied, suspended or revoked.

(4) A notice under paragraph (2) may specify information which the licensing authority, or the Commission, an expert advisory group of the Commission, or an expert committee appointed by the licensing authority, thinks necessary for considering whether the notice should be varied, suspended or revoked.

Miscellaneous and offences

Certification of manufacturer's licence

31. —(1) The licensing authority must issue a certificate in accordance with the following paragraphs of this regulation in relation to a manufacturer's licence relating to the manufacture or assembly of medicinal products if requested to do so by—

(a) subject to paragraph (5), the holder of the licence;

(b) a person who intends to export a medicinal product manufactured or assembled by the holder under the licence; or

(c) the competent authorities of a country other than the United Kingdom into which a medicinal product manufactured or assembled under the licence is, or is proposed to be, imported.

(2) The certificate must contain —

(a) information sufficient to identify the holder of the manufacturer's licence;

(b) details of the medicinal products that may be manufactured or assembled under the licence; and

(c) any other information concerning the holder, the product or the licence that the licensing authority thinks it appropriate to include, including information relating to clinical trials.

(3) If—

(a) a request is made—

(i) under paragraph (1)(a) in relation to the export or the proposed export of a product, or

(ii) under paragraph (1)(b) or (c); and

(b) there is a UK marketing authorisation ..., Article 126a authorisation or a traditional herbal registrationin force for any product to which the licence relates,

the certificate must be accompanied by the summary of the product characteristics relating to that product.

(4) The licensing authority may restrict the information provided under sub-paragraphs (2)(a) and (b) and paragraph (3) to information relating to the specific medicinal products mentioned in the request made under paragraph (1).

(5) A licence holder who makes a request under paragraph (1) must—

(a) produce to the licensing authority a UK marketing authorisation ..., Article 126a authorisation , certificate of registration or traditional herbal registration in relation to any product to which the certificate is to relate; or

(b) make a declaration to the licensing authority explaining why no UK marketing authorisation ..., Article 126a authorisation , certificate of registration or traditional herbal registration is available.

(6) The licensing authority must have regard to the prevailing administrative arrangements of the World Health Organisation when issuing the certificate.

Sale and supply of starting materials

32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Offence concerning data for advanced therapy medicinal products

33. —(1) A person who is, or immediately before its revocation or suspension was, the holder of a manufacturer's licence relating to an advanced therapy medicinal product is guilty of an offence if the person fails to—

(a) keep the data referred to in paragraph 8 of Schedule 6 in accordance with the requirements of paragraph 9 of that Schedule ; or

(b) transfer the data referred to in paragraph 8 to the licensing authority in the event of that person's bankruptcy or liquidation,

but this is subject to paragraphs (2) and (3).

(2) Sub-paragraph (1)(b) does not apply if—

(a) the person is bankrupt or in liquidation and has transferred the data to another person; or

(b) the period for which the person was required to keep the data in accordance with the requirements of paragraph 9 mentioned in sub-paragraph (1)(a) has expired.

(3) It is a defence for a person charged with an offence under paragraph (1) to prove that the person took all reasonable precautions and exercised all due diligence to avoid commission of the offence.

(4) Where evidence is adduced that is sufficient to raise an issue with respect to the defence in paragraph (3), the court or jury must presume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.

Offences: breach of regulations and false information and defence concerning starting materials

34. —(1) A person is guilty of an offence if the person contravenes the provisions of regulation 17(1) or 18(1) .

(2) A person is guilty of an offence if the person knowingly gives false information in response to a notice under regulation 30(1).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 30(2).

(4) The defence in paragraph (5) applies to a person who is charged under paragraph (1) with an offence of contravening regulation 17(1) (prohibition on manufacturing a medicinal product except in accordance with a licence) by virtue of a breach of regulation 37(3) (requirement that active substances used as starting materials are manufactured or assembled in accordance with the Good Manufacturing Practice Directive).

(5) It is a defence for the person to show that the person could not, by taking all reasonable precautions and exercising all due diligence, have discovered that an active substance was not manufactured in accordance with regulation 37(3) .

Penalties

35. —(1) A person guilty of an offence under regulation 33(1) or regulation 34(1) or (2) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 34(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

Conditions for holding a manufacturer's licence

Conditions for manufacturer's licence

36. —(1) Regulations 37 to 41 apply to the holder of a manufacturer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a manufacturer's licence insofar as the licence relates to the manufacture or assembly of exempt advanced therapy medicinal products).

(2) Those provisions are regulations 37(3) , 38, 39(6)(a) and (8) , 40 and 41.

(3) The requirements of Part 1 of Schedule 6 apply to the holder of a manufacturer's licence insofar as the licence relates to the manufacture or assembly of exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturing and assembly

37.—(1) This regulation applies in relation to a manufacturer’s licence relating to the manufacture or assembly of medicinal products.

(2) The licence holder must comply with the principles and guidelines for good manufacturing practice set out in the Good Manufacturing Practice Directive which apply under or by virtue of regulation B17 .

(3) Unless paragraph (10) applies, the licence holder shall use active substances as starting materials only if—

(a) those substances have been manufactured in accordance with good manufacturing practice for active substances; and

(b) those substances have been distributed in accordance with the guidelines on good distribution practice for active substances.

(4) The licence holder shall verify—

(a) that the manufacturer or distributor of an active substance used by the licence holder has complied with the requirements of good manufacturing practice and good distribution practice for active substances by means of audits performed—

(i) directly by the licence holder, or

(ii) by a person acting on behalf of the licence holder under a contract;

(b) that unless the active substance is imported into Great Britain from a country other than an approved country for import or into Northern Ireland from a country other than an EEA State from a third country, any manufacturers, importers or distributors supplying active substances to the licence holder—

(i) in the case of a productimported into Great Britain, are registered with the appropriate authority for the registration of such persons in the approved country for import, and

(ii) in the case of a productimported into Northern Ireland, are registered with the competent authority of a member State in which they are established; and

(c) the authenticity and quality of the active substance.

(5) The licence holder shall ensure that—

(a) excipients are suitable for use in a medicinal product by—

(i) ascertaining what the appropriate good manufacturing practice is, and

(ii) ensuring that the ascertained good manufacturing practice is applied;

(b) the suitability of the excipient is ascertained on the basis of a formalised risk assessment as described ... in the guidelines which apply under or by virtue of regulation C17 (including in the case of a listed NIMAR product for sale or supply from Great Britain to Northern Ireland) ;

(c) the assessment under sub-paragraph (b) takes account of—

(i) the source,

(ii) requirements under other quality systems,

(iii) intended use of the excipients, and

(iv) previous instances of quality defects,

(d) the authenticity and quality of any excipient used is verified; and

(e) the measures taken under this paragraph are documented by the licence holder.

(6) The licence holder must maintain such staff, premises and equipment as are necessary for the stages of manufacture and assembly of medicinal products undertaken by the licence holder in accordance with—

(a) the manufacturer’s licence; ...

(aa) in the case of a product for supply as an EAMS medicinal product, the conditions attached to the EAMS scientific opinion in respect of the product; and

(b) in the case of a product for sale or supply—

(i) in Great Britain (including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland) , the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK), or

(ii) in Northern Ireland, the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisations or Article 126a authorisations,

applying to the medicinal products.

(7) The licence holder must not manufacture or assemblemedicinal products, or classes of medicinal products, other than those specified in the licence.

(8) The licence holder must not manufacture or assemblemedicinal products on premises other than those specified in the licence as approved by the licensing authority for the purpose.

(9) The licence holder must ensure that blood, or blood components, imported into the United Kingdom and used as a starting material or raw material in the manufacture of a medicinal product meet—

(a) the standards of quality and safety specified in the Blood Quality and Safety Regulations 2005 ; or

(b) equivalent standards.

(10) The requirements in paragraphs (3) to (5) do not apply in relation to the manufacture or assembly of special medicinal product to which regulation 167 (supply to fulfil special needs) applies or an EAMS medicinal product to which regulation 167E(1) to (4) (EAMS medicinal product: manufacture, assembly, importation, distribution and supply) applies .

(11) The licence holder must immediately inform the licensing authority and, where applicable, the UK marketing authorisation holder, of medicinal products which come within the scope of manufacturing authorisation which the licence holder—

(a) knows or suspects; or

(b) has reasonable grounds for knowing or suspecting,

to be falsified.

Imports from states other than EEA States / countries other than approved countries for import

38. —(1) This regulation applies in relation to a manufacturer's licence relating to the import of medicinal products.

(2) The licence holder must comply with the conditions set out in this regulation in relation to the import of medicinal products from—

(a) in the case of an import into Great Britain, a country other than an approved country for import, or

(b) in the case of an import into Northern Ireland, a country other than an EEA State .

(3) The licence holder must—

(a) comply with the principles and guidelines on good manufacturing practice in the Good Manufacturing Practice Directive in so far as they are relevant to the import of medicinal products; and

(b) ensure that active substances have been used as starting materials in the manufacture of medicinal products, other than special medicinal products, imported from , in the case of an import into Great Britain, a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State only if those substances have been manufactured or assembled in accordance with good manufacturing practice for active substances .

Further requirements for manufacturer's licence

39. —(1) This regulation applies in relation to any manufacturer's licence.

(2) The licence holder must maintain such staff, premises, equipment and facilities for the handling, control, storage and distribution of medicinal products under the licence as are appropriate in order to maintain the quality of the medicinal products.

(3) The licence holder must ensure that any arrangements made for the handling, control, storage and distribution of medicinal products are adequate to maintain the quality of the products.

(4) The licence holder must not handle, control, store or distribute medicinal products on any premises other than those specified in the licence as approved by the licensing authority for the purpose.

(5) The licence holder must inform the licensing authority before making a material alteration to the premises or facilities used under the licence, or to the purposes for which those premises or facilities are used.

(6) The licence holder must inform the licensing authority of any proposed change to—

(a) the qualified person; and

(b) any person named in the licence as having responsibility for quality control.

(7) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority to do anything that the licensing authority could have done for the purposes of verifying a statement made in an application for a licence.

(8) In distributing a medicinal product by way of wholesale dealing, the licence holder must comply with the following as if they are a holder of a wholesale dealer’s licence—

(a) regulations 43(1), (2) and (5), 43ZA and 44(5) and (6) .

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Obligation to provide information relating to control methods

40. —(1) This regulation applies in relation to any manufacturer's licence.

(2) The licensing authority may require the licence holder to provide the authority with proof of the control methods employed by the holder in relation to a medicinal product.

Requirements as to qualified persons

41. —(1) This regulation applies in relation to any manufacturer's licence.

(2) The licence holder must ensure that there is at the disposal of the holder at all times at least one qualified person who is responsible for carrying out, in relation to medicinal products manufactured, assembled or imported under the licence, the duties specified in Part 3 of Schedule 7.

(3) If the licence holder satisfies the requirements of Part 1 or 2 of Schedule 7 the licence holder may act as a qualified person.

(4) A qualified person may be treated by the licence holder as satisfying the requirements of Part 1 or 2 of Schedule 7 if that person produces evidence that he or she—

(a) is a member of a body specified in paragraph (5); and

(b) is regarded by that body as satisfying those requirements.

(5) Those bodies are—

(a) the Society of Biology;

(b) the Royal Pharmaceutical Society;

(c) the Pharmaceutical Society of Northern Ireland;

(d) the Royal Society of Chemistry; and

(e) such other body as may be specified by the licensing authority for the purpose of this paragraph.

(6) Where the qualified person changes, the licence holder must give the licensing authority advance notification of—

(a) that change; and

(b) the name, address and qualifications of the new qualified person.

(7) The licence holder must not permit any person to act as a qualified person other than the person named in the licence or another person notified to the licensing authority under paragraph (6).

(8) Paragraph (9) applies if the licensing authority thinks, after giving the licence holder and a person acting as a qualified person the opportunity to make representations (orally or in writing), that the person—

(a) does not satisfy the requirements of Part 1 or 2 of Schedule 7 in relation to qualifications or experience;

(b) does not satisfy paragraph (b) of the definition of “qualified person” in regulation 8; or

(c) is failing to carry out the duties referred to in paragraph (2) adequately or at all.

(9) Where this paragraph applies, the licensing authority must notify the licence holder in writing that the person is not permitted to act as a qualified person.

(10) The licence holder must at all times provide and maintain such staff, premises and equipment as are necessary to enable the qualified person to carry out the duties referred to in paragraph (2).

(11) The licence holder is not obliged to meet the requirements of this regulation in relation to any activity under the licence which relates to special medicinal products or , unless conditions attached in accordance with regulation 174A(1) provide otherwise, to products authorised on a temporary basis under regulation 174 (supply in response to spread of pathogenic agents etc).

(12) The licence holder is not obliged to meet the requirements of this regulation in relation to any activities under the licence which relate to EAMS medicinal products, unless the conditions attached to the scientific opinion in respect of that product in accordance with regulation 167C(2)(c) provide otherwise.

Conditions for holding a wholesale dealer's licence

Conditions for wholesale dealer's licence

42. —(1) Regulations 43 to 45 (not including regulation 43ZA) (in the case of a wholesale dealer’s licence held in Northern Ireland) or regulations 43 to 45AA (including regulation 43ZA) (in the case of a wholesale dealer’s licence held in Great Britain) apply to the holder of a wholesale dealer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products).

(2) Those provisions are regulations 43(2) and (8) and 44.

(3) The requirements in Part 2 of Schedule 6 apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Obligations of licence holder

43.—(1) The licence holder must comply with the guidelines on good distribution practice—

(a) in the case of a licence holder in Great Britain, published under, or that apply by virtue of, regulation C17;

(b) in the case of a licence holder in Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive.

(2) The licence holder must ensure, within the limits of the holder's responsibility, the continued supply of medicinal products to pharmacies, and other persons who may lawfully sell medicinal products by retail or supply them in circumstances corresponding to retail sale, so that the needs of patients in the United Kingdom are met.

(3) The licence holder must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of medicinal products under the licence as are necessary—

(a) to maintain the quality of the products; and

(b) to ensure their proper distribution.

(4) The licence holder must inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or which have otherwise been approved by the licensing authority.

(5) Subject to paragraph (6), the licence holder must not sell or supply a medicinal product, or offer it for sale or supply, unless—

(a) in the case of a product for sale or supply—

(i) in Great Britain, there is a UKMA(GB), UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), or

(ii) in Northern Ireland, there is a UKMA(NI), UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK) ... or an Article 126a authorisation (an “authorisation”),

in force in relation to the product; and

(b) the sale or supply, or offer for sale or supply, is in accordance with the authorisation.

(6) The restriction in paragraph (5) does not apply to—

(a) the sale or supply, or offer for sale or supply, of a special medicinal product in the United Kingdom ;

(aa) the supply, or offer for supply, of an unauthorised EAMS medicinal product in the United Kingdom;

(b) the export from Northern Ireland to an EEA State, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that State without a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration by virtue of legislation adopted by that State under Article 5(1) of the 2001 Directive; ...

(ba) the export from Great Britain to an approved country for import, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that country without—

(i) a marketing authorisation, certificate of registration or traditional herbal registration within the meaning of the 2001 Directive, by virtue of legislation adopted by that country under Article 5(1) of that Directive, where the approved country for import is an EEA State, or

(ii) such equivalent authorisation, certificate or registration in the approved country for import, under legislation in that country that makes provision that is equivalent to Article 5(1) of the 2001 Directive, where the approved country for import is not an EEA State.

(c) the sale or supply, or offer for sale or supply, of an unauthorised medicinal product where the Secretary of State has temporarily authorised the distribution of the product under regulation 174; or

(d) the wholesale distribution of medicinal products—

(i) from Northern Ireland to a person in a country other than Great Britain or a country other than an EEA State; or

(ii) from Great Britain to a person in a country other than Northern Ireland or a country other than an approved country for import.

(7) The licence holder must—

(a) keep documents relating to the sale or supply of medicinal products under the licence which may facilitate the withdrawal or recall from sale of medicinal products in accordance with paragraph (b);

(b) maintain an emergency plan to ensure effective implementation of the recall from the market of a medicinal product where recall is—

(i) ordered by the licensing authority or—

(aa) in the case of a licence holder in Great Britain, by an appropriate authority for the licensing of medicinal products in an approved country for import;

(bb) in the case of a licence holder in Northern Ireland, by the competent authority of any EEA State, or

(ii) carried out in co-operation with the manufacturer of, or the holder of—

(aa) in the case of a product for sale or supply in Great Britain, the UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration, or

(bb) in the case of a product for sale or supply in Northern Ireland, the UKMA(NI) or UKMA(UK) ..., Article 126a authorisation, certificate of registration or traditional herbal registration,

for, the product; and

(c) keep records in relation to the receipt, dispatch or brokering of medicinal products, of—

(i) the date of receipt,

(ii) the date of despatch,

(iii) the date of brokering,

(iv) the name of the medicinal product,

(v) the quantity of the product received, dispatched or brokered,

(vi) the name and address of the person from whom the products were received or to whom they are dispatched,

(vii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) A licence holder in Northern Ireland (“L”) who imports from another EEA State a medicinal product in relation to which L is not the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or a traditional herbal registration shall—

(a) notify the intention to import that product to the holder of the authorisation and—

(i) in the case of a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004 , to the EMA ; or

(ii) in any other case, the licensing authority; and

(b) pay a fee to the EMA in accordance with Article 76(4) of the 2001 Directive or the licensing authority as the case may be, in accordance with the Fees Regulations,

but this paragraph does not apply in relation to the wholesale distribution of medicinal products to a person in a country other than an EEA State .

(8A) Paragraph (8B) applies to a person (“P”) who—

(a) imports into Great Britain a medicinal product, other than for the sole purpose of wholesale distribution of that product to a person in a country other than the United Kingdom; but

(b) is not the holder of a UK marketing authorisation, certificate of registration or traditional herbal registration in respect of that product.

(8B) Where this paragraph applies, P must—

(a) notify—

(i) the holder of any authorisation, certificate or registration, granted by an authority in the country from which the product is exported, to sell or supply that product in that country, and

(ii) the licensing authority,

of the intention to import that product; and

(b) pay a fee to the licensing authority in accordance with the Fees Regulations.

(9) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any samples or copies, which an inspector could carry out or take under Part 16 (enforcement).

(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(12) The licence holder must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.

(13) The licence holder must immediately inform the licensing authority and, where applicable, the UK marketing authorisation holder ... , of medicinal products which the licence holder receives or is offered which the licence holder—

(a) knows or suspects; or

(b) has reasonable grounds for knowing or suspecting,

to be falsified.

(14) Where the medicinal product is obtained through brokering—

(a) a licence holder in Great Britain must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b);

(b) a licence holder in Northern Ireland must verify that the broker involved is validly registered with the licensing authority or the competent authority of an EEA State.

(15) In this regulation as it applies in the case of a product for sale or supply in Northern Ireland , “marketing authorisation” means—

(a) a marketing authorisation issued by a competent authority in accordance with the 2001 Directive; or

(b) an EU marketing authorisation.

Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland

43ZA.—(1) This regulation applies only to licence holders in Great Britain supplying listed NIMAR products to Northern Ireland.

(2) A licence holder must comply with the guidelines on good distribution practice, published under, or that apply by virtue of, regulation C17.

(3) So that the needs of patients in Northern Ireland are met, the licence holder must ensure, within the limits of the holder’s responsibility, the continued supply of listed NIMAR products to—

(a) registered pharmacies in Northern Ireland;

(b) any person who may lawfully sell those products by retail sale or may lawfully supply them in circumstances corresponding to retail sale in Northern Ireland;

(c) any person who may lawfully administerprescription only medicines in Northern Ireland.

(4) The licence holder must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of listed NIMAR products under the licence as are necessary—

(a) to maintain the quality of the products; and

(b) to ensure their proper distribution.

(5) The licence holder must inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or which have otherwise been approved by the licensing authority.

(6) The licence holder must not sell or supply, or offer for sale or supply, listed NIMAR products to a person in Northern Ireland, unless—

(a) there is a UKMA(UK) or UKMA(GB)in force in relation to that product; and

(b) the sale or supply is in accordance with that authorisation (except for the fact the product will be in Northern Ireland).

(7) The licence holder must—

(a) keep documents relating to the sale or supply of listed NIMAR products under the licence which may facilitate the withdrawal or recall from sale of such products in accordance with paragraph (b);

(b) maintain an emergency plan to ensure effective implementation of the recall from the market of a listed NIMAR product where recall is—

(i) ordered by the licensing authority or

(ii) carried out in co-operation with the manufacturer of, or the holder of the corresponding UKMA(GB) or UKMA(UK) for the product; and

(c) keep records in relation to the receipt, dispatch or brokering of listed NIMAR products, of—

(i) the date of receipt,

(ii) the date of despatch,

(iii) the date of brokering,

(iv) the name of the listed NIMAR product,

(v) the quantity of the product received, dispatched or brokered,

(vi) the name and address of the person from whom the products were received or to whom they are dispatched; and

(d) provide the records in sub-paragraph (c) to the licensing authority on request.

(8) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any samples or copies, which an inspector could carry out or take under Part 16 (enforcement).

(9) The licence holder must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.

(10) The licence holder must immediately inform the licensing authority of medicinal products which the licence holder receives or is offered which the licence holder—

(a) knows or suspects; or

(b) has reasonable grounds for knowing or suspecting,

to be falsified.

(11) Where the listed NIMAR product is obtained through brokering, a licence holder must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b).

Requirement for wholesale dealers to decommission the unique identifier

43A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirement for wholesale dealers to deal only with specified persons

44.—(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The licence holder must not obtain supplies of medicinal products from anyone except—

(a) the holder of a manufacturer’s licence or wholesale dealer’s licence in relation to products of that description;

(b) the person who holds an authorisation granted by an approved country for import (in the case of a licence holder in Great Britain) or by an EEA State (in the case of a licence holder in Northern Ireland) authorising the manufacture of products of the description or their distribution by way of wholesale dealing; or

(c) where the medicinal product is directly received—

(i) in the case of a licence holder in Great Britain, from a country that is not an approved country for import (“A”), for export to a country that is not an approved country for import (“B”), and

(ii) in the case of a licence holder in Northern Ireland, from a country other than an EEA State (“A”) for export to another country other than an EEA State (“B”),

the supplier of the medicinal product in country A is a person who is authorised or entitled to supply such medicinal products in accordance with the legal and administrative provisions in country A.

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Where a medicinal product is obtained in accordance with paragraph ... (2)(a) or (b), the licence holder must verify that—

(a) the wholesale dealer who supplies the product complies with the principles and guidelines of good distribution practices; or

(b) the manufacturer or importer who supplies the product holds a manufacturing authorisation.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) The licence holder may distribute medicinal products by way of wholesale dealing only to—

(a) the holder of a wholesale dealer’s licence relating to those products;

(b) the holder of an authorisation granted by—

(i) in the case of a licence holder in Great Britain, the appropriate authority of an approved country for import;

(ii) in the case of a licence holder in Northern Ireland, the competent authority of an EEA State,

that is responsible for authorising the supply of those products by way of wholesale dealing;

(c) a person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale;

(d) a person who may lawfully administer those products; or

(e) in relation to supply—

(i) in the case of a licence holder in Great Britain to persons in countries other than approved countries for import, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country to which the product is supplied;

(ii) in the case of a licence holder in Northern Ireland to persons in a country other than an EEA State, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country other than an EEA State concerned.

(6) Where a medicinal product is supplied to a person who is authorised or entitled to supply medicinal products to the public in accordance with paragraph ... (5)(c) or (e), the licence holder must enclose with the product a document stating the—

(a) date on which the supply took place;

(b) name and pharmaceutical form of the product supplied;

(c) quantity of product supplied; and

(d) name and address of the licence holder .

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) The licence holder must—

(a) keep a record of information supplied in accordance with paragraph (6) for at least five years beginning immediately after the date on which the information is supplied; and

(b) ensure that the record is available to the licensing authority for inspection.

(8) A licence holder in Great Britain may only obtain a medicinal product in respect of which a UKMA(UK)(Category 2) was granted under the unfettered access route if the product satisfies the definition of qualifying Northern Ireland goods.

(9) Paragraph (2)(c) does not apply to—

(a) in the case of a licence holder in Great Britain, products received from Northern Ireland, and

(b) in the case of a licence holder in Northern Ireland, products received from Great Britain.

(10) Paragraph (5)(e) does not apply to—

(a) in the case of a licence holder in Great Britain, products supplied to Northern Ireland, and

(b) in the case of a licence holder in Northern Ireland, products supplied to Great Britain.

Requirement as to responsible persons

45. —(1) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “ responsible person ”) who in the opinion of the licensing authority—

(a) has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate to carry out the functions mentioned in paragraph (2); and

(b) has adequate experience relating to those activities and procedures.

(1A) In respect of a licence holder in Great Britain, paragraph (1) is subject to regulation 45AA.

(2) Those functions are—

(a) ensuring that the conditions under which the licence was granted have been, and are being, complied with; and

(b) ensuring that the quality of medicinal products handled by the licence holder is being maintained in accordance with the requirements of—

(i) in the case of a licence holder in Great Britain, the UK marketing authorisations, certificates of registration or traditional herbal registrations, and

(ii) in the case of a licence holder in Northern Ireland, the marketing authorisations, requirements of regulation 167A, Article 126a authorisations, certificates of registration or traditional herbal registrations,

applicable to those products.

(3) The licence holder must notify the licensing authority of—

(a) any change to the responsible person; and

(b) the name, address, qualifications and experience of the responsible person.

(4) The licence holder must not permit any person to act as a responsible person other than the person named in the licence or another person notified to the licensing authority under paragraph (3).

(5) Paragraph (6) applies if, after giving the licence holder and a person acting as a responsible person the opportunity to make representations (orally or in writing), the licensing authority thinks that the person—

(a) does not satisfy the requirements of paragraph (1) in relation to qualifications or experience; or

(b) is failing to carry out the functions referred to in paragraph (2) adequately or at all.

(6) Where this paragraph applies, the licensing authority must notify the licence holder in writing that the person is not permitted to act as a responsible person.

Requirement as to responsible persons where licence holder imports from an approved country for import

45AA.—(1) Subject to paragraph (2), this regulation applies to a licence holder in Great Britain where the licence holder imports a medicinal product from an approved country for import under a wholesale dealer's licence.

(2) The requirements of this regulation do not apply where an unlicensed medicinal product falling under paragraph (1) is imported—

(a) from an approved country for import for the sole purpose of distribution by way of wholesale dealing as a special medicinal product; or

(b) for the sole purpose of wholesale distribution of that product to a person in a country other than an approved country for import.

(3) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “ responsible person (import) ”) whose name is included in the register established under regulation 45AB.

(4) A responsible person (import) must—

(a) carry out the functions under regulation 45(2), unless a responsible person under regulation 45 is performing those functions in respect of the licence; ...

(b) ensure that there is appropriate evidence to confirm that each production batch of a medicine imported from an approved country for import under the licence has been certified as provided for in Article 51 of the 2001 Directive, or such equivalent certification procedure as applies in the approved country for import; and

(c) ensure that each production batch of a medicinal product that is subject to the batch testing condition and that is imported into Great Britain from an approved country for import has been certified as being in conformity with the approved specifications in the UK marketing authorisation by—

(i) the appropriate authority, or

(ii) where the batch testing exemption applies, a laboratory in a country that has an agreement with the United Kingdom to the effect that the appropriate authority will recognise that certificate in place of the appropriate authority’s own examination.

(5) The licensing authority must publish guidance on the documentation that it considers to be appropriate evidence for the purposes of paragraph (4)(b).

(6) Guidance published under paragraph (5) may be taken into account by the licensing authority in determining whether it considers there has been a failure to comply with this regulation.

(7) The licence holder must apply to vary the licence if a change is proposed to the responsible person (import).

(8) The licence holder must not permit any person to act as a responsible person (import) other than the person named in the licence.

(9) Paragraph (10) applies if—

(a) the person acting as responsible person (import) in respect of the licence is no longer included in the register under 45AB;

(b) the licensing authority thinks, after giving the licence holder and a person acting as a responsible person (import) the opportunity to make representations (orally or in writing), that the responsible person (import) is failing to carry out the functions referred to in paragraph (4) adequately or at all.

(10) Where this paragraph applies the licensing authority—

(a) must notify the licence holder in writing that the person is not permitted to act as a responsible person (import) in respect of that licence; and

(b) may, subject to regulation 45AB(3)(b), remove that person's name from the register under regulation 45AB.

(11) In this regulation, “ unlicensed medicinal product ” means a medicinal product in respect of which—

(a) there is no marketing authorisation, within the meaning of the 2001 Directive, in any EEA State in respect of that product, where the product is imported from an approved country for import that is an EEA State; or

(b) there is no licence or authorisation in respect of that product as regards its sale or supply in the approved country for import, where the product is imported from an approved country for import that is not an EEA State.

Register for responsible persons (import)

45AB.—(1) The licensing authority must maintain a register of persons (“ the responsible person (import) register ”) who may carry out the role of responsible person (import) under regulation 45AA.

(2) The licensing authority may only include a person's name in the responsible person (import) register if that person—

(a) holds—

(i) a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology or a related life science, or

(ii) such other qualification as the licensing authority is satisfied is equivalent;

(b) is a member of—

(i) the Royal Society of Biology,

(ii) the Royal Pharmaceutical Society,

(iii) the Pharmaceutical Society of Northern Ireland,

(iv) the Royal Society of Chemistry, or

(v) such other body as may be specified by the licensing authority for the purpose of this paragraph; and

(c) has a minimum of 2 years' experience in performing the functions of a responsible person under regulation 45, or in performing such other functions that appear to the licensing authority to be equivalent.

(3) The licensing authority—

(a) may remove a person's name from the responsible person (import) register if it no longer considers that the person satisfies the requirements of paragraph (2); but

(b) it may not exercise that power unless it has given that person the opportunity to make representations to it (orally or in writing).

CHAPTER 3 Brokering

Brokering in medicinal products

45A.—(1) A person may not broker a medicinal product in Great Britain unless—

(a) the product is covered by an authorisation granted—

(i) by the licensing authority, or

(ii) by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, and

(b) that person—

(i) is validly registered as a broker with the licensing authority,

(ii) has a permanent address in the United Kingdom, and

(iii) complies with the guidelines on good distribution practice which apply under, or by virtue of, regulation C17 insofar as those guidelines apply to brokers.

(1A) A person may not broker a medicinal product in Northern Ireland unless—

(a) the product is covered by an authorisation granted—

(i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii) by the licensing authority, or

(iii) by a competent authority of a member State, and

(b) that person—

(i) is validly registered as a broker with the licensing authority or a competent authority of a member State,

(ii) except where the person is validly registered with the competent authority of an EEA State, has a permanent address in the United Kingdom, and

(iii) complies with the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive insofar as those guidelines apply to brokers.

(2) A person is not validly registered for the purpose of paragraph (1)(b) or (1A)(b) if—

(a) the person’s permanent address is not entered into a register of brokers kept by a competent authority of a member State or the licensing authority (as appropriate) ;

(b) the registration is suspended; or

(c) the person has notified the competent authority of a member State or the licensing authority (as appropriate) to remove that person from the register.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application for brokering registration

45B.—(1) The licensing authority may not register a person as a broker unless paragraphs (2) to (7) are complied with.

(2) An application for registration must be made containing—

(a) the name of the person to be registered;

(b) the name under which that person is trading (if different to the name of that person);

(c) that person’s—

(i) permanent address in the United Kingdom,

(ii) e-mail address, and

(iii) telephone number;

(d) a statement of whether the medicinal products to be brokered are—

(i) prescription only medicines,

(ii) pharmacy medicines, or

(iii) medicines subject to general sale;

(e) an indication of the range of medicinal products to be brokered;

(f) evidence that that person can comply with regulations 45A(1)(b)(iii), 45E(3)(a) to (f) and 45F(1); and

(g) any fee payable in connection with the application in accordance with the Fees Regulations.

(3) Where the address at which the emergency plan, documents or record necessary to comply with regulation 45E(3)(b) to (d) are kept is different from the address notified in accordance with sub-paragraph (2)(c)(i), the application must contain—

(a) that address where the plan or records are to be kept;

(b) the name of a person who can provide access to that address for the purpose of regulation 325 (rights of entry); and

(c) that person’s—

(i) address,

(ii) e-mail address, and

(iii) telephone number.

(4) Unless paragraph (6) applies, the application for registration must—

(a) be in English; and

(b) be signed by the person seeking a brokering registration.

(5) The pages of the application must be serially numbered.

(6) Where the application is made on behalf of the person seeking a brokering registration by another person (“A”), the application must—

(a) contain the name and address of A; and

(b) be signed by A.

Procedure for determining an application for broker’s registration

45C.—(1) The licensing authority must grant or refuse an application for registration under regulation 45B within the period of 90 days beginning immediately after the day on which it receives the application.

(2) Paragraph (1) applies to an application only if the requirements of regulation 45B(2) have been met.

(3) Before determining an application for a brokering registration, the licensing authority may notify the applicant of a requirement to provide such information as the licensing authority thinks necessary, within the period specified by the licensing authority.

(4) If a notice under paragraph (3) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (1).

(5) In paragraph (4), the “information period” means the period—

(a) beginning with the day on which the notice is given, and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.

Grant or refusal of broker’s registration

45D.—(1) Subject to regulations 45E and 45F, on an application to the licensing authority for a brokering registration, the licensing authority must, if it considers it necessary and appropriate to do so—

(a) register the applicant as a broker; or

(b) refuse registration as a broker, having regard to—

(i) the provisions of these Regulations, ...

(ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The licensing authority must give the applicant a notice stating the reasons for its decision in any case where the licensing authority—

(a) refuses to grant an application for registration; or

(b) grants registration otherwise than in accordance with the application and the applicant requests a statement of its reasons.

(3) The licensing authority must register the applicant or refuse registration under this Chapter within the period of 90 days beginning immediately after the day on which it receives the application.

(4) Where the licensing authority registers a person as a broker, the licensing authority must enter the following information into a publicly available register—

(a) the person’s name;

(b) the name under which that person is trading (if different from the person’s name);

(c) the person’s permanent address in the United Kingdom.

(5) The licensing authority must make the register of brokers publicly available.

Criteria of broker’s registration

45E.—(1) Registration of a broker is conditional on that broker—

(a) complying with regulation 45A(1); and

(b) satisfying—

(i) the criteria in paragraphs (3), (4) and (7), and

(ii) such other criteria as the licensing authority considers appropriate and notifies the broker of.

(2) The criteria referred to in paragraph (1)(b)(ii) may include (but are not limited to) the criteria specified in paragraphs (5) and (6).

(3) The broker must—

(a) have a permanent address in the United Kingdom;

(b) maintain an emergency plan to ensure effective implementation of the recall from the market of a medicinal product where recall is—

(i) ordered by—

(aa) in the case of a broker in Great Britain, the licensing authority or by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(bb) in the case of a broker in Northern Ireland, the licensing authority or by the competent authority of any EEA State, or

(ii) carried out in co-operation with the manufacturer of, or the holder of the marketing authorisation, for the product;

(c) keep documents relating to the sale or supply of medicinal products under the licence which may facilitate the withdrawal or recall from sale of medicinal products in accordance with sub-paragraph (b);

(d) record in relation to the brokering of each medicinal product—

(i) the name of the medicinal product,

(ii) the quantity of the product brokered,

(iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv) the name and address of the—

(aa) supplier, or

(bb) consignee, and

(v) the date on which the sale or purchase of the product is brokered;

(e) maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities; and

(f) keep the documents or record required by sub-paragraph (c) or (d) available to the licensing authority for a period of five years; and

(g) comply with regulation 45F(1), (2) and (4).

(4) Where the address at which the plan or records necessary to comply with paragraph (3)(b) to (d) are kept is different from the address notified in accordance with regulation 45B(2)(c)(i), the broker must—

(a) ensure that the plan or records are kept at an address in the United Kingdom; and

(b) inform the licensing authority of the address at which the plan or records are kept.

(5) The broker must provide such information as may be requested by the licensing authority concerning the type and quantity of medicinal products brokered within the period specified by the licensing authority.

(6) The broker must take all reasonable precautions and exercise all due diligence to ensure that any information provided by that broker to the licensing authority in accordance with regulation 45F is not false or misleading.

(7) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the registration, the broker must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any copies, which an inspector may carry out or take under regulations 325 (rights of entry) and 327 (powers of inspection, sampling and seizure).

Provision of information

45F.—(1) A broker registered in the UK must immediately inform—

(a) the licensing authority; and

(b) the UK marketing authorisation holder, or, where applicable—

(i) the holder of the licence or authorisation granted by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(ii) the EU marketing authorisation holder,

of medicinal products which the broker identifies as, suspects to be, or has reasonable grounds for knowing or suspecting to be, falsified.

(2) On or before the date specified in paragraph (3), a broker who is, or has applied to the licensing authority to become, a registered broker in the United Kingdom must submit a report to the licensing authority, which—

(a) includes a declaration that the broker has in place an appropriate system to ensure compliance with regulations 45A, 45B and this regulation; and

(b) details the system which the broker has in place to ensure such compliance.

(3) The date specified for the purposes of this paragraph is—

(a) in relation to any application made before 31st March 2014, the date of the application; and

(b) in relation to each subsequent reporting year, 30th April following the end of that year.

(4) The broker must without delay notify the licensing authority of any changes to the matters in respect of which evidence has been supplied in relation to paragraph (2) which might affect compliance with the requirements of this Chapter.

(5) Any report or notification to the licensing authority under paragraph (2) or (4) must be accompanied by the appropriate fee in accordance with the Fees Regulations.

(6) The licensing authority may give a notice to a registered broker requiring that broker to provide information of a kind specified in the notice within the period specified in the notice.

(7) A notice under paragraph (6) may not be given to a registered broker unless it appears to the licensing authority that it is necessary for the licensing authority to consider whether the registration should be varied, suspended or revoked.

(8) A notice under paragraph (6) may specify information which the licensing authority thinks necessary for considering whether the registration should be varied, suspended or revoked.

(9) In paragraph (3)(b), “reporting year” means a period of twelve months ending on 31st March.

Power to suspend or vary a broker’s registration or remove a broker from the register

45G.—(1) The licensing authority may in accordance with regulation 45H—

(a) suspend a broker’s registration for such period as the authority thinks fit;

(b) vary a broker’s registration; or

(c) remove a person from the register.

(2) The suspension of registration or removal from the register may be—

(a) total;

(b) limited to medicinal products of one or more descriptions; or

(c) limited to medicinal products manufactured, assembled or stored on specified premises or a specified part of any premises.

(3) The powers conferred by this regulation may not be exercised in relation to a broker’s registration except on one or more of the following grounds—

(a) the information in the application as a result of which the broker’s registration was granted was false or incomplete in a material respect;

(b) a material change of circumstances has occurred in relation to any of the matters stated in the application;

(c) the broker has materially contravened a criterion of registration; or

(d) the broker has without reasonable excuse failed to supply information to the licensing authority with respect to medicinal products of a description to which the registration relates when required to do so under regulation 45F(6).

Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register

45H.—(1) This regulation applies where—

(a) regulation 45I does not apply; and

(b) the licensing authority proposes to exercise the power in regulation 45G(1).

(2) The licensing authority must notify the broker in writing of—

(a) its proposal;

(b) the reasons for it; and

(c) the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, variation or revocation should take effect.

(3) The registered broker may before the date specified in the notice—

(a) make written representations to the licensing authority with respect to the proposal; or

(b) notify the licensing authority that the broker wishes the licensing authority to submit the proposal to review upon oral representations.

(4) If the broker makes written representations in accordance with paragraph (3)(a) the licensing authority must take those representations into account before making a decision in the matter.

(5) Schedule 5 has effect if the registered broker—

(a) notifies the licensing authority of the proposal to review upon oral representations in accordance with paragraph (3)(b); and

(b) pays the fee for a review upon oral representations in accordance with the Fees Regulations.

(6) If the licensing authority proceeds to suspend or vary a registration or remove a broker from the register in accordance with the provisions of regulation 45G it must give a notice to the broker.

(7) A notice under paragraph (6) must—

(a) give particulars of the suspension, variation or removal; and

(b) give reasons for the decision to suspend, vary or remove a broker from the register.

(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

Suspension of a broker registration in cases of urgency

45I.—(1) The licensing authority may immediately suspend a broker’s registration for a period not exceeding three months where it appears to the licensing authority that in the interests of safety it is appropriate to do so.

(2) This paragraph applies where—

(a) a broker’s registration has been suspended under paragraph (1); and

(b) it appears to the licensing authority that it is necessary to consider whether the broker’s registration should be—

(i) further suspended or varied, or

(ii) removed from the brokers’ register.

(3) Where paragraph (2) applies, the licensing authority must proceed as set out in regulation 45H (but this is subject to paragraph (4)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the licensing authority proceeds as set out in regulation 45H and any proceedings under that regulation have not been finally disposed of before the end of the period for which the registration was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the licensing authority to be necessary in the interests of safety to do so, the authority may further suspend the registration for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 45H to suspend, vary or revoke the registration is made on an application under regulation 322(4), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (validity of decisions and proceedings).

Variation of a broker’s registration on the application of the broker

45J.—(1) This regulation applies if the person registered as a broker applies to the licensing authority for a variation of the registration.

(2) The application must—

(a) be in writing;

(b) specify the variation requested;

(c) be signed by or on behalf of the applicant;

(d) be accompanied by such information as may be required to enable the licensing authority to consider the application;

(e) include the appropriate fee in accordance with the Fees Regulations.

(3) The licensing authority must vary a broker’s registration or refuse to vary it within 30 days beginning with the day after the date when the licensing authority receives the application.

(4) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

(5) If a notice under paragraph (4) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (3).

(6) In paragraph (5), the “information period” means the period—

(a) beginning with the day on which notice is given; and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority’s satisfaction that the applicant is unable to provide it.

(7) Nothing in this regulation affects the powers conferred by regulations 45G and 45I.

Offences: breach of regulations and false information

45K.—(1) A person is guilty of an offence if the person—

(a) contravenes regulation 45A(1); or

(b) brokers a medicinal product otherwise than in accordance with the criteria under regulation 45E relating to that person’s brokering registration.

(2) A person is guilty of an offence if the person knowingly gives false information in—

(a) an application for a broker registration under regulation 45B(2);

(b) a notification to the licensing authority under regulation 45F(4);

(c) an application for a variation under regulation 45J(1); or

(d) response to a notice under regulation 45C(3) or 45J(5).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 45F(6) or 45J(5).

Penalties

45L.—(1) A person guilty of an offence under regulation 45K(1) or (2) is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 45K(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

CHAPTER 4 Importation, manufacture and distribution of active substances

Criteria for importation, manufacture or distribution of active substances

45M.—(1) A person may not—

(a) import;

(b) manufacture; or

(c) distribute,

an active substance unless that person is registered with the licensing authority in accordance with regulation 45N and the requirements in regulation 45O are met.

(2) Paragraph (1) applies in relation to an active substance which is to be used in an investigational medicinal product only—

(a) if—

(i) in the case of a product for sale or supply in Great Britain, the product has a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii) in the case of a product for sale or supply in Northern Ireland, the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration, and

(b) to the extent that the manufacture of the active substance is in accordance with the terms and conditions of that authorisation, certificate or registration.

(3) Paragraph (1)(a) does not apply to a person who, in connection with the importation of an active substance ... —

(a) provides facilities solely for transporting the active substance; or

(b) acting as an import agent, imports the active substance solely to the order of another person who holds a certificate of good manufacturing practice issued by the licensing authority.

Registration in relation to active substances

45N.—(1) For registration in relation to active substances, the licensing authority must have received a valid registration form from the applicant for import, manufacture or, as the case may be, distribution of an active substance and—

(a) 60 days have elapsed since receipt and the licensing authority have not notified the applicant that an inspection will be carried out; or

(b) the licensing authority—

(i) notified the applicant within 60 days of receipt of a registration form that an inspection will be carried out; and

(ii) within 90 days of that inspection the licensing authority have issued that person with a certificate of good manufacturing practice or, as the case may be, of good distribution practice; and

(c) that person has not instructed the licensing authority to end that person’s registration.

(2) The person applying for registration under paragraph (1) must notify the licensing authority of any changes which have taken place as regards the information in the registration form—

(a) immediately where such changes may have an impact on quality or safety of the active substances that are manufactured, imported or distributed;

(b) in any other case, on each anniversary of the receipt of the application form by the licensing authority.

(3) For the purpose of paragraph (2), changes which are notified in accordance with that paragraph shall be treated as incorporated in the application form.

(4) Any notification to the licensing authority under paragraph (2) must be accompanied by the appropriate fee in accordance with the Fees Regulations.

(5) A registration form is valid for the purpose of paragraph (1) if—

(a) it is provided to the licensing authority; and