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The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Type Statutory-Instrument

Publication 2020-12-08

Last updated 2021-08-03

State In force

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Made: 8th December 2020

Coming into force in accordance with regulation 1

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1) and 8C of, and paragraphs 1(1) and 7(2) of Schedule 4 and 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018 .

The Treasury has consented to the making of these Regulations as required by paragraphs 3(1) and 10 of Schedule 4 to the European Union (Withdrawal) Act 2018.

In accordance with paragraphs 1(1), 8F(1) and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of these Regulations has been laid before, and approved by, a resolution of each House of Parliament.

Citation and commencement

1

These Regulations may be cited as the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 and come into force immediately before IP completion day.

Amendment of the Good Laboratory Practice Regulations 1999

2

In the Good Laboratory Practice Regulations 1999 —

(a) omit regulation 5(4)(b) (and the “or” at the end of sub-paragraph (a)), and

(b) in regulation 6(4), omit “unless, in order” to the end.

Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

3

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 are amended in accordance with Schedule 1.

Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

4

The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 are amended in accordance with Schedule 2.

Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

5

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 are amended in accordance with Schedule 3.

SCHEDULE 1 — Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

1

In regulation 3 (amendment of regulation 2 (interpretation))—

(a) in paragraph (2), for the substituted definition of “ Commission Directive 2003/94/EC ” substitute—

“Commission Directive 2003/94/EC”, other than in Parts 2 and 3 of Schedule 7, means— (a) in the case of an investigational medicinal product manufactured or assembled in, or imported into, Great Britain— (i) Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A to the 2012 Regulations, or (ii) if Regulations have been made under the powers in regulation B17(1) of the 2012 Regulations, and have come into force, those Regulations; (b) in the case of an investigational medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use;

(b) in paragraph (6), for the substituted definition of “ import ” substitute—

“import”, except in regulation 13 and Schedule 13, means import, or attempt to import— (a) into Great Britain other than from Northern Ireland, or (b) into Northern Ireland from a country other than an EEA State, whether by land, sea or air and “imported” is to be construed accordingly;;

(d) in paragraph (8), for the substituted definition of “ marketing authorization ” substitute—

“marketing authorization” means— (a) a UK marketing authorization, (b) an EU marketing authorisation (as defined in the 2012 Regulations), or (c) an authorization granted by a regulatory body responsible for licensing medicinal products in a country that is included in the list referred to in regulation 2A(1);

(e) omit paragraph (9);

(f) in paragraph (11), for the inserted definition of “UK marketing authorization” substitute—

“UK marketing authorization”— (a) has the same meaning as “UK marketing authorisation” in the 2012 Regulations (and references to “UKMA(UK)”, “UKMA(GB)” and “UKMA(NI)” in these Regulations should be construed in accordance with that definition); and (b) includes a product licence granted by the licensing authority for the purposes of section 7 of the Medicines Act 1968;

2

In regulation 7 (amendment of regulation 13 (supply of investigational medicinal products for the purpose of clinical trials))—

(a) in paragraph (2), for the inserted sub-paragraph (b), substitute—

(b) in the case of— (i) an investigational medicinal product manufactured or assembled in the United Kingdom, the product has been manufactured or assembled— (aa) in accordance with the terms of a manufacturing authorisation, or (bb) in the case of assembly only, under the exemption in regulation 37; (ii) an investigational medicinal product imported into Northern Ireland from an EEA State— (aa) the product has been manufactured, assembled or imported into an EEA State in accordance with the terms of an authorisation referred to in Article 13 of the Directive granted by a competent authority of an EEA State, and (bb) the production batch of investigational medicinal products of which the product is a part has been checked and certified by a qualified person pursuant to Article 13(3) and (4) of the Directive; (iii) an investigational medicinal product imported into Northern Ireland from a country other than an EEA State, the product has been imported into Northern Ireland in accordance with the terms of a manufacturing authorisation; (iv) an investigational medicinal product imported into Great Britain other than from Northern Ireland, the product has been imported in accordance with the terms of a manufacturing authorisation.

(b) in paragraph (3), in the inserted paragraph (2A)—

(i) omit “UK”;

(ii) after “marketing authorization” insert “ or marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC ”;

(5) For paragraph (4) substitute— (4) The restriction in paragraph (1) shall not apply to— (a) the sale or supply of a medicinal product in Great Britain in accordance with the terms of a UKMA(GB) or UKMA(UK), and (b) the sale or supply of a medicinal product in Northern Ireland in accordance with— (i) the terms of a UKMA(NI) or UKMA(UK), or (ii) an EU marketing authorisation (as defined in the 2012 Regulations).

3

For regulation 17 (amendment of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products)) substitute—

(17) In regulation 36(2), after “marketing authorization” insert “ or marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC ”.

4

For regulation 18 (amendment of regulation 43 (qualified persons)) substitute—

(18) In regulation 43— (a) for paragraphs (1) and (2) substitute— (1) Subject to paragraphs (4) and (5), the holder of a manufacturing authorisation must have at his disposal the services of at least one qualified person— (a) where the manufacturing authorisation relates wholly to the import of an investigational medicinal product into Great Britain from an approved country for import, who must operate and be ordinarily resident in either the United Kingdom or an approved country for import, or (b) in any other case, who must operate and be ordinarily resident in the United Kingdom, and who is responsible for carrying out the duties referred to in paragraph 2. (2) Subject to paragraphs (2A) and (2C), the qualified person is responsible for ensuring that— (a) in the case of an investigational medicinal product manufactured in Northern Ireland, each production batch has been manufactured and checked in compliance with— (i) the requirements of these Regulations; (ii) the principles and guidelines of good manufacturing practice; (iii) the product specification, as defined in Part 1 of Schedule 7; and (iv) the request, particulars and documents submitted to the licensing authority under regulation 17 in respect of the clinical trial in which the product is to be used; (b) in the case of an investigational medicinal product manufactured in Great Britain, each production batch has been manufactured and checked in compliance with— (i) the requirements of these Regulations; (ii) the principles and guidelines of good manufacturing practice, as modified by Schedule 2A to the 2012 Regulations or any regulations made under the power in regulation B17(1) of those Regulations; (iii) the product specification, as defined in Part 1 of Schedule 7; and (iv) the request, particulars and documents submitted to the licensing authority under regulation 17 in respect of the clinical trial in which the product is to be used; (c) in the case of an investigational medicinal product imported into Northern Ireland from a country other than an EEA State, each production batch has been manufactured and checked in compliance with— (i) standards of good manufacturing practice at least equivalent to the principles and guidelines of good manufacturing practice; (ii) the product specification, as defined in Part 1 of Schedule 7; and (iii) the request, particulars and documents submitted to the licensing authority under regulation 17 in respect of the clinical trial in which the product is to be used; (d) in the case of an investigational medicinal product imported into Great Britain other than from Northern Ireland, each production batch has been manufactured and checked in compliance with— (i) standards of good manufacturing practice at least equivalent to the principles and guidelines of good manufacturing practice, as modified by Schedule 2A to the 2012 Regulations or any regulations made under the power in regulation B17(1) of those Regulations; (ii) the product specification, as defined in Part 1 of Schedule 7; and (iii) the request, particulars and documents submitted to the licensing authority under regulation 17 in respect of the clinical trial in which the product is to be used. (2A) The qualified person is not responsible for carrying out the controls in paragraph (2) where— (a) the product is imported into Great Britain from a country that is included on the list referred to in regulation 43A (“approved country for import”); and (b) the qualified person ensures that there is appropriate evidence to confirm that each production batch has been certified as provided for in Article 13 of the Directive, or such equivalent certification procedure as applies in the approved country for import. (2B) The licensing authority must publish guidance on the evidence that it considers to be appropriate for the purposes of paragraph (2A)(b). (2C) The qualified person is not responsible for carrying out the controls in paragraph (2) where— (a) an investigational medicinal product— (i) which has a marketing authorization other than a UKMA(GB), is imported into Northern Ireland as a comparator product; or (ii) which has a marketing authorization, or has been approved for marketing in another country, is imported into Great Britain as a comparator product; and (b) documentation cannot be obtained certifying that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 2003/94/EC. (2D) Where paragraph (2) does not apply by virtue of paragraph (2C), the qualified person is responsible for ensuring that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the request, particulars and documents submitted to the licensing authority under regulation 17. (2E) The qualified person is responsible for ensuring, in relation to an investigational medicinal product, that documentary evidence is produced that each batch of the product satisfies the provisions of paragraph (2), (2A) or (2D) (as the case may be). (2F) The documentary evidence referred to in paragraph (2E) must be— (a) kept up to date as operations are carried out; and (b) available for inspection by the licensing authority for a period of at least five years beginning with the date on which the documentary evidence is produced. (b) for paragraph (5) substitute— (5) For the purposes of this paragraph, but without prejudice to paragraph (6) below, the holder of the authorisation may regard a person as satisfying the provisions of the said Article 49 or 50, as respects formal qualifications if— (a) in relation to the obligation in paragraph (1)(a), he is already named as a qualified person in respect of an authorisation issued in an approved country for import; or (b) he produces evidence that— (i) he is a member of— (aa) the Institute of Biology, (bb) the Pharmaceutical Society, (cc) the Royal Society of Chemistry, or (dd) such other body as may appear to the licensing authority to be an appropriate body for the purpose of this paragraph; and (ii) he is regarded by the body of which he is a member as so satisfying those provisions.

5

In regulation 19 (insertion of regulation 43A (approved country for import)), in the inserted regulation 43A, for “the United Kingdom” in both places it occurs substitute “ Great Britain ”.

6

In regulation 20 (amendment of regulation 45 (suspension and revocation of manufacturing authorisation)), for “omit “or any equivalent provisions in any EEA State other than the United Kingdom”.” substitute “for “or any equivalent provisions in any EEA State other than the United Kingdom” substitute “ or, in the case of an investigational medicinal product manufactured or assembled in Northern Ireland, any equivalent provisions in any EEA State ”.”.

7

In regulation 23 (insertion of regulation 57 (functions in relation to good clinical practice)), in the inserted regulation 57—

(a) in paragraph (1), after “Regulations may” insert “ , in respect of Great Britain ”;

(b) for paragraphs (2) and (3) substitute—

(2) Any power to make regulations under paragraph (1)— (a) is exercisable by the Secretary of State by statutory instrument; (b) includes power to make— (i) different provision for different purposes or different areas; (ii) consequential, supplementary, incidental, transitional, transitory or saving provisions, including consequential amendments to these Regulations. (3) Regulations under paragraph (1) are subject to annulment in pursuance of a resolution of either House of Parliament.

8

In regulation 24 (amendment of Schedule 3 (particulars and documents that must accompany an application for an ethics committee opinion, a request for authorisation, a notice of amendment and a notification of the conclusion of a trial))—

(a) for paragraph (3)(c) substitute—

(c) in paragraph 7, after “details of any” insert “ manufacturing authorisation or any ”;

(b) for paragraph (3)(d)(i) substitute—

(i) in sub-paragraph (1), after “in accordance with” insert “ regulation 43(2) or ”;

(ii) for sub-paragraph (2) substitute— (2) If an investigational medicinal product to be used in the clinical trial has been, or is to be— (a) imported into Great Britain from a country other than Northern Ireland or imported into Northern Ireland from a country other than an EEA State, a statement from the qualified person at the disposal of the person holding the manufacturing authorisation in relation to that importation specifying— (i) the address of any premises outside the United Kingdom at which the product was manufactured or assembled; and (ii) the manufacturing or assembling operations performed at those premises; (b) imported into Northern Ireland from an EEA State, a statement from the qualified person at the disposal of the person holding the authorisation referred to in Article 13 of the Directive in relation to that importation specifying— (i) the address of any premises outside the European Economic Area at which the product was manufactured or assembled; and (ii) the manufacturing or assembling operations performed at those premises.

9

For regulation 25 (amendment of Schedule 7 (standard provisions for manufacturing authorisations)) substitute—

(25) In Part 1 of Schedule 7— (a) for “In this Schedule,” substitute “ In this Schedule— ”; (b) the definition of “product specification” becomes part of a list of definitions; (c) before the definition of “product specification” insert— “Commission Directive 2003/94/EC”, in relation to the holder of an authorisation means— (a) in the case of a holder in Great Britain— (i) Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A to the 2012 Regulations, or (ii) if Regulations have been made under the powers in regulation B17(1) of the 2012 Regulations, and have come into force, those Regulations; (b) in the case of a holder in Northern Ireland, Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use; (d) in the definition of “product specification”, for paragraph (a) substitute— (a) in the case of an investigational medicinal product manufactured before a request for authorisation to conduct the clinical trial involving those products has been made— (i) in the case of an investigational medicinal product manufactured or assembled in Great Britain, in accordance with regulation 17, or (ii) in the case of an investigational medicinal product manufactured or assembled in Northern Ireland, in accordance with regulation 17 or any equivalent provisions in any EEA State, the specification for that product provided by the person who is to act as the sponsor of the proposed clinical trial,

10

In regulation 26 (insertion of Schedule 13 (transitional provisions in relation to EU Exit)), in the inserted Schedule 13—

(a) for “exit day” in each place it occurs substitute “ IP completion day ”;

(b) in paragraph 3—

(i) in the heading to the paragraph, after “medicinal products” insert “ into Great Britain ”;

(ii) in sub-paragraph (1), after “that is imported” insert “ into Great Britain ”.

SCHEDULE 2 — Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 1 — Amendment of Part 2 (amendment of Part 1 (General))

1

In regulation 4 (definitions in relation to advanced therapy medicinal products), in the inserted regulation 2A, in paragraphs (1) and (10), after “In these Regulations,” insert “ in their application to products for sale or supply in Great Britain only, ”.

2

In regulation 5 (amendment of regulation 3 (scope of Regulations: special provisions))—

(a) for paragraph (2)(b) and (c) substitute—

(b) after paragraph (i) insert— (ia) the EU marketing authorisation,

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

3

In regulation 6 (amendment of regulation 4 (special provision for pharmacies etc) substitute—

(6) In regulation 4— (a) in paragraph (4)(d)— (i) in paragraph (i) insert “ UK ” before “marketing authorisation”; (ii) after paragraph (i) insert— (ia) the EU marketing authorisation, (b) in paragraph (6) for “269 (offences relating to packaging and package leaflets: other persons)” substitute “ 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) ”.

4

In regulation 7 (amendment of regulation 5 (classification of medicinal products))—

(a) for paragraph (2) substitute—

(2) In paragraph (1)(b), before “a product that” insert “ in the case of a medicinal product for sale or supply in Northern Ireland, ”.

(b) in paragraph (3)—

(i) omit sub-paragraph (a);

(ii) for sub-paragraph (b) substitute—

(b) in sub-paragraph (d), before “an Article 126a” insert “ in the case of a medicinal product for sale or supply in Northern Ireland, ”.

(i) for sub-paragraph (a) substitute—

(a) in sub-paragraph (b), before “a medicinal product” insert “ in the case of a medicinal product for sale or supply in Northern Ireland, ”;

(ii) omit sub-paragraph (b);

(d) in paragraph (5) for “omit sub-paragraph (b)” to the end substitute “in sub-paragraph (b), before “an Article” insert “ in the case of a medicinal product for sale or supply in Northern Ireland, ”.”; and

(e) in paragraph (6)—

(i) for sub-paragraph (a) substitute—

(a) in sub-paragraph (b), before “a product that” insert “ in the case of a medicinal product for sale or supply in Northern Ireland, ”; and

; and

(ii) omit sub-paragraph (b).

5

For regulation 8 (amendment of Schedule 1 (further provisions for classification of medicinal products)) substitute—

(8) In Schedule 1— (a) in paragraph 1— (i) in sub-paragraph (b), insert “ UK ” before “marketing authorisation”; (ii) in sub-paragraphs (e)(i), (f)(i) and (g)(i), for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation, Article 126a authorisation or parallel import licence ”; and (b) in paragraph 4, for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation, Article 126a authorisation, parallel import licence ”.

6

Omit regulation 9 (amendment of regulation 6 (the licensing authority and the Ministers)).

7

In regulation 10 (amendment of regulation 8 (general interpretation))—

(a) in paragraph (2)—

(i) in the definition of—

(aa) “Annex I to the 2001 Directive”, after “means” insert “ , in relation to UKMA(GB), ”;

(bb) “conditional marketing authorisation”, for “UK marketing authorisation” substitute “ UKMA(GB) ”;

(ii) at the appropriate place in the list of definitions to be inserted, insert—

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

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

; and

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

“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;

“under the unfettered access route” means an application for— (a) a UKMA(GB) under reduced or alternative requirements specified in Part 5 (as referred to in regulation 49(1A)); (b) a COR(GB) under reduced or alternative requirements specified in Part 6 (as referred to in regulation 103(1A)); (c) a THR(GB) under reduced or alternative requirements specified in Part 7 (as referred to in regulation 127(1A));

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

(b) in paragraph (3)—

(i) before sub-paragraph (a) insert—

(za) in the definition of “advanced therapy medicinal product”, after “means” insert “ , in the case of a medicinal product for sale or supply by the holder of a UKMA(NI) or UKMA(UK), ”; (zb) in the definition of “certificate of registration”, after “these Regulations” insert— and— (a) “COR(UK)” means such a certificate in force in the whole United Kingdom; (b) “COR(GB)” means such a certificate in force in Great Britain only; (c) “COR(NI)” means such a certificate in force in Northern Ireland only;

(ii) for sub-paragraph (a) substitute—

(a) for the definition of “the Good Manufacturing Practice Directive” substitute— “the Good Manufacturing Practice Directive” means— (a) in the case of a medicinal product manufactured or assembled in, or imported into, Great Britain— (i) Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A, or (ii) if Regulations have been made under the powers in regulation B17(1), and have come into force, those Regulations; (b) in the case of a medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use;

(iii) in sub-paragraph (b) (amendment of definition of “homoeopathic medicinal product”) for “substitute “the British Pharmacopoeia”” to the end substitute—

substitute— (i) in relation to a certificate of registration or marketing authorisation for a national homoeopathic product in force in Great Britain only, the British Pharmacopoeia, or in an pharmacopoeia used officially in an country that is included in a list published by the licensing authority for this purpose; (ii) in relation to a certificate of registration or marketing authorisation for a national homoeopathic product in force in the whole United Kingdom or in Northern Ireland only, in the British Pharmacopoeia or in any pharmacopoeia used officially in an EEA State;

(iv) omit sub-paragraph (d) (amendment of definition of “name”);

(v) in sub-paragraph (e) (amendment of definitions of “pharmacovigilance system”, “pharmacovigilance system master file” and “post-authorisation safety study”) for “for “marketing authorisation, traditional” to the end substitute “for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation ””;

(vi) for sub-paragraph (j) (amendment of definition of “the summary of the product characteristics”) substitute—

(j) in the definition of “traditional herbal registration”, after “these Regulations” insert— and— (a) “THR(UK)” means such a registration in force in the whole United Kingdom; (b) “THR(GB)” means such a registration in force in Great Britain only; (c) “THR(NI)” means such a registration in force in Northern Ireland only;

(vii) for sub-paragraph (k) (amendment of definition of “UK marketing authorisation”) substitute—

(k) for the definition of “UK marketing authorisation” substitute— “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— (a) “UKMA(UK)” means such an authorisation in force in the whole United Kingdom; (b) “UKMA(GB)” means such an authorisation in force in Great Britain only; (c) “UKMA(NI)” means such an authorisation in force in Northern Ireland only.

(d) after paragraph (7) insert—

(8) After paragraph (8) insert— (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), COR(UK) or THR(UK).

PART 2 — Amendment of Part 3 (amendment of Part 3 (manufacture and distribution of medicinal products and active substances))

8

In regulation 13 (new regulation B17 and C17 (good manufacturing practice and good distribution practice))—

(a) in the inserted regulation B17—

(i) in paragraph (1)—

(aa) for “Ministers” substitute “ Secretary of State ”;

(bb) after “by regulations” insert “ in respect of Great Britain ”;

(ii) in paragraph (2)(b) after “UK marketing authorisation” insert “ or EU marketing authorisation ”;

(iii) in paragraph (3)—

(aa) after “have effect” insert “ in Great Britain ”;

(bb) for “exit day” in both places it occurs substitute “ IP completion day ”;

(iv) in paragraph (4)—

(aa) for “Ministers” substitute “ Secretary of State ”;

(bb) after “by regulations” insert “ in respect of Great Britain ”;

(b) in the inserted regulation C17—

(i) in paragraph (1), after “may publish” insert “ in relation to the manufacture or assembly of a medicinal product in, or import to, Great Britain ”;

(ii) in paragraph (3) for “exit day” in both places it occurs substitute “ IP completion day ”.

9

In regulation 14 (amendment of regulation 17 (manufacturing of medicinal products))—

(a) for paragraph (2) substitute—

(2) For paragraph (1) substitute— (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).

(b) omit paragraph (3);

(4) In paragraph (4), after sub-paragraph (a) insert— (aa) a UK marketing authorisation; or

(d) for paragraph (5) substitute—

(5) In paragraph (5) omit “from a state other than an EEA State”.

(e) after paragraph (5) insert—

(6) After paragraph (6) insert— (7) Paragraph (1) does not apply to imports into Northern Ireland from Great Britain of— (a) special medicinal products, and (b) medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day. (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.

10

In regulation 15 (amendment of regulation 18 (wholesale dealing in medicinal products))—

(a) in paragraph (2)(c), in the inserted sub-paragraph (c)—

(i) after “medicinal product” insert “ into Great Britain ”;

(ii) omit “for either purpose”;

(b) after paragraph (2) insert—

(2A) After paragraph (2) insert— (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) For paragraph (6) substitute— (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, or (b) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in respect of the product, but this is subject to the exceptions in regulation 43(6).

(d) for paragraph (4) substitute—

(4) In paragraph (7) for “paragraph (6)” substitute “ paragraph (6)(b) ”.

11

In regulation 17 (amendment of regulation 19 (exemptions from requirement for wholesale dealer's licence))—

(a) for paragraph (2) substitute—

(2) For paragraph (1)(a) substitute— (a) the holder of— (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”) 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), an EU marketing authorisation 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) after paragraph (3) insert—

(4) At the end insert— (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.

12

In regulation 18 (amendment of Schedule 3 (applications for licences under Part 3))—

(a) for paragraph (2) substitute—

(2) For paragraph 1(2)(g) substitute— (g) the name, address, qualifications and experience of the person with responsibility for quality control in relation to the medicinal products to be manufactured or assembled under the licence (and, if that responsibility is to be carried out by the holder of— (i) in the case of a product for sale or supply in Great Britain, the UK marketing authorisation, certificate of registration or traditional herbal registration relating to the products, or (ii) in the case of a product for sale or supply in Northern Ireland, the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to the products, a statement of that fact);

(b) for paragraph (3) substitute—

(3) For paragraph 2(1) substitute— (2) (1) This paragraph applies to an application for a manufacturer's licence relating to the import from— (a) in the case of an import into Great Britain, a country other than Northern Ireland or 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, of medicinal products.

(i) for sub-paragraph (i) substitute—

(i) for paragraph (i) substitute— (i) in the case of a product for sale or supply in Great Britain, a UK marketing authorisation, (ia) in the case of a product for sale or supply in Northern Ireland, a marketing authorisation,

(ii) for sub-paragraph (ii) substitute—

(ii) in paragraph (iv) before “an Article” insert “ in the case of a product for sale or supply in Northern Ireland, ”, and

(d) in paragraph (4)(c)(iii), in the inserted paragraph (iii), after “export” insert “ from Great Britain ”.

13

After regulation 19 (amendment of regulation 23 (grant or refusal of licence)) insert—

(19A) In regulation 24, after paragraph (2) insert— (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.

14

In regulation 20 (amendment of Schedule 4 (standard provisions of licences under Part 3))—

(a) for paragraph (2) substitute—

(2) For paragraph 13(b) substitute— (b) in the case of a product for sale or supply— (i) in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or (ii) in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration, contains provisions relating to them,

(b) after paragraph (2) insert—

(2A) After paragraph 14 insert— (14A) A licence holder— (a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and (b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain, in response to an order which satisfies the requirements of regulation 167.

(3) In the heading of Part 2, after “State Other Than an EEA State” insert “ / Country other than an Approved Country for Import ”.

(d) for paragraph (4) substitute—

(4) In paragraph 15, for “from a state other than an EEA State” substitute— from— (a) in the case of an import into Great Britain, a country other than Northern Ireland or 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 (4A) In paragraphs 22(1) and 23, for “a state other than an EEA State” substitute “ , in the case of an import into Great Britain, a country other than Northern Ireland or 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 ”. (4B) After paragraph 23, insert— (23A) A licence holder— (a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and (b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain, in response to an order which satisfies the requirements of regulation 167.

(e) for paragraph (6) substitute—

(6) In paragraph 33, for “another EEA State” substitute “ , in the case of an import into Great Britain, an approved country for import and in the case of an import into Northern Ireland, an EEA State ”.

(f) after paragraph (6) insert—

(7) After paragraph 41 insert— (41A) A licence holder— (a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and (b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain, in response to an order which satisfies the requirements of regulation 167.

15

For regulation 21 (amendment of regulation 26 (general power to suspend, revoke or vary licences)) substitute—

(21) For regulation 26(5)(a) substitute— (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”), 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) or a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”), and has habitually failed to comply with the provisions of that authorisation; or

16

In regulation 24 (amendment of regulation 31 (certification of manufacturer's licence)) for paragraph (3) substitute—

(3) In paragraphs (3)(b), (5)(a) and (5)(b) for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation, Article 126a authorisation ”.

17

In regulation 27 (amendment of regulation 36 (conditions for manufacturer's licence)) for “, omit paragraphs (4) to (7)” substitute—

(a) in paragraph (4)— (i) for “The requirements” substitute “ Where a manufacturer's licence relates to the manufacture or assembly of a medicinal product in, or import of a medicinal product into, Northern Ireland, the requirements ”; (ii) for “provisions of a manufacturer's” substitute “ provisions of that ”; (b) in paragraph (6), after “by way of wholesale dealing” insert “ in Northern Ireland ”.

18

In regulation 28 (amendment of regulation 37 (manufacturing and assembly))—

(a) after paragraph (1) insert—

(1A) In paragraph (2), after “Good Manufacturing Practice Directive” insert “ which apply under or by virtue of regulation B17 ”.

(b) for paragraph (2) substitute—

(2) For paragraph (4)(b) substitute— (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 product imported 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 product imported into Northern Ireland, are registered with the competent authority of a member State in which they are established; and

(3) In paragraph (5)(b), after “as described” insert “in the case of a product for sale or supply in Great Britain, in the guidelines which apply under or by virtue of regulation C17 and, in the case of a product for sale or supply in Northern Ireland,

(d) for paragraph (4) substitute—

(4) For paragraph (6)(b) substitute— (b) in the case of a product for sale or supply— (i) in Great Britain, 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.

19

In regulation 29 (amendment of regulation 38 (imports))—

(a) for paragraph (2) substitute—

(2) In the heading, after “states other than EEA states” insert “ / countries other than approved countries for import ”.

(b) for paragraph (3) substitute—

(3) In paragraph (2) for “from a state other than an EEA State” substitute— 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

(4) In paragraph (3)(b) for “a state other than an EEA State” substitute “ , 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 ”.

20

In regulation 30 (amendment of regulation 39 (further requirements for manufacturer's licence))—

(a) “omit “, 43A”” becomes paragraph (a);

(b) after paragraph (a) insert—

and (b) after “and (6)” insert “ and, where the product is being distributed in Northern Ireland, regulation 43A, ”.

21

In regulation 31 (amendment of regulation 42 (conditions for wholesale dealer's licence))—

(a) for paragraph (2) substitute—

(2) In paragraph (1), after “45” insert “ (in the case of a wholesale dealer's licence held in Northern Ireland) or regulations 43 to 45AA (in the case of a wholesale dealer's licence held in Great Britain) ”.

(b) for paragraph (3) substitute—

(3) In paragraph (4)— (a) for “The requirements” substitute “ Where a wholesale dealer's licence relates to wholesale dealings in Northern Ireland, the requirements ”; and (b) for “provisions of a wholesale dealer's” substitute “ provisions of that ”.

22

In regulation 32 (amendment of Schedule 7 (qualified persons))—

(a) after paragraph (3)(a)(i) insert—

(ia) for “The qualified person” substitute “ In Great Britain, the qualified person ”;

(b) in paragraph (3)(a)(ii), before sub-paragraph (aa), insert—

(zaa) for “the United Kingdom” substitute “ Great Britain ”;

(c) in paragraph (3)(a)(iii)(aa) after “medicinal products imported from” insert “ a country other than Northern Ireland or ”;

(d) after paragraph (3)(a) insert—

(aa) after paragraph 12 insert— (12A) (1) In Northern Ireland, the qualified person is responsible for securing— (a) that each batch of medicinal products manufactured in Northern Ireland has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and (b) in the case of medicinal products imported from a country other than an EEA State, irrespective of whether the products have been manufactured in Northern Ireland or an EEA State, that each batch has undergone— (i) a full qualitative analysis, (ii) a quantitative analysis of all the active substances, and (iii) all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and (c) in the case of medicinal products, other than radiopharmaceuticals, that are required to bear safety features pursuant to Article 54a of the 2001 Directive and not intended to be exported to a country other than an EEA State, that the features specified in paragraph 18A of Schedule 24 have been affixed on the packaging.

(e) for paragraph (3)(b) substitute—

(b) in paragraph 13— (i) in sub-paragraph (1) after “This paragraph applies” insert “ in Northern Ireland ”; (ii) in sub-paragraph (1)(a) for “paragraph 12 in another member State is imported to the United Kingdom” substitute “ paragraph 12A in a member State is imported to Northern Ireland ”; (iii) in sub-paragraph (2) for “12” substitute “ 12A ”;

(f) in paragraph (3)(c)—

(i) for paragraph (i) substitute—

(i) in sub-paragraph (1)(a) after “are imported” insert “into Great Britain from a country other than an approved country for import or into Northern Ireland;

(ii) for paragraph (ii) substitute—

(ii) for sub-paragraph (1)(b) substitute— (b) appropriate arrangements have been made, in the case of import into Great Britain by the licensing authority with the country from which those products are imported and, in the case of a product for import into Northern Ireland by the European Union with that country, to ensure that— (i) the manufacturer of the medicinal products applies standards of good manufacturing practice at least equivalent to those laid down— (aa) in the case of a product for sale or supply in Great Britain, in the Good Manufacturing Practice Directive, as supplemented by the guidelines and principles which apply under, or by virtue of, regulation C17, and (bb) in the case of a product for sale or supply in Northern Ireland, by the European Union; (ii) the controls referred to in paragraph 12(b) or 12A(b) (as appropriate) have been carried out in that country.

(iii) after paragraph (ii) insert—

(iia) in paragraph (2) after “paragraph 12” insert “ or 12A ”.

23

In regulation 33 (amendment of regulation 43 (obligations of licence holder))—

(a) for paragraph (2) substitute—

(2) For paragraph (1), substitute— (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.

(b) for paragraph (3) substitute—

(3) For paragraph (5)(a) substitute— (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), and EU marketing authorisation or an Article 126a authorisation (an “authorisation”), in force in relation to the product; and

(aa) in sub-paragraph (b), after “the export” insert “ from Northern Ireland ”;

(d) in paragraph (4)(b)—

(i) for “for sub-paragraph (b), substitute” substitute “ after sub-paragraph (b), insert ”;

(ii) in the text inserted by that paragraph—

(aa) renumber the paragraph to be inserted as “(ba)”;

(bb) after “the export” insert “ from Great Britain ”;

(e) after paragraph (4)(b) insert—

(c) for sub-paragraph (d) substitute— (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.

(f) in paragraph (5)(a)—

(i) for paragraph (i) substitute—

(i) for sub-paragraph (i) substitute— (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) for paragraph (ii) substitute—

(ii) for sub-paragraph (ii) substitute— (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), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration, for, the product; and

(g) for paragraph (5)(b) substitute—

(b) in sub-paragraph (c)(vii), before “the batch number” insert “ where the receipt, dispatch or brokering of medicinal products takes places in Northern Ireland, ”;

(h) after paragraph (5) insert—

(5A) In paragraph (8)— (a) after “A licence holder” insert “ in Northern Ireland ”; (b) for “third country” substitute “ “country other than an EEA State”.

(i) in paragraph (6)—

(i) for “For paragraph (8) substitute” substitute “ After paragraph (8) insert ”;

(ii) renumber the paragraphs to be inserted as (8A) and (8B) respectively;

(iii) in the newly renumbered paragraph (8A)—

(aa) for “Paragraph (8A)” substitute “ Paragraph (8B) ”;

(bb) in sub-paragraph (a), after “imports” insert “ into Great Britain ”;

(j) for paragraph (7) substitute—

(7) In paragraph (10), after “The holder” insert “ of a licence relating to wholesale dealings in Northern Ireland ”.

(k) for paragraph (8) substitute—

(8) In paragraph (13), for “marketing authorisation holder” substitute “ UK marketing authorisation holder or EU marketing authorisation holder ”.

(l) for paragraph (9) substitute—

(9) For paragraph (14) substitute— (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. (10) In paragraph (15), after “In this regulation” insert “ as it applies in the case of a product for sale or supply in Northern Ireland ”.

24

For regulation 34 (omission of regulation 43A (requirement for wholesale dealers to decommission the unique identifier)) substitute—

(34) In regulation 43A— (a) in paragraph (2) for “in the United Kingdom” substitute “ in Northern Ireland ”; and (b) in paragraph (3)— (i) in sub-paragraph (g) omit “a police force in England, Wales or Scotland or”; and (ii) in sub-paragraph (l) for “care” substitute “ nursing ”.

25

In regulation 35 (amendment of regulation 44 (requirement for wholesale dealers to deal only with specified persons))—

(a) in paragraph (2)—

(i) for sub-paragraph (a) substitute—

(a) in sub-paragraph (b), for “another EEA State” substitute “ 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) ”; and

(ii) for sub-paragraph (b) substitute—

(b) for sub-paragraph (c) substitute— (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.

(b) for paragraph (3) substitute—

(3) For paragraph (5)(b) substitute— (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;

(4) For paragraph (5)(e) substitute— (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.

(d) for paragraph (5)(b) substitute—

(b) in sub-paragraph (e) after “of the 2001 Directive” insert “ , in the case of a licence holder in Northern Ireland. ”.

(e) after paragraph (5) insert—

(6) After paragraph (7) insert— (8) A licence holder in Great Britain may only obtain a medicinal product in respect of which a UKMA(GB) 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.

26

In regulation 36 (amendment of regulation 45 (requirement as to responsible persons))—

(a) for paragraph (2) substitute—

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

(b) for paragraph (3) substitute—

(3) For paragraph (2)(b) substitute— (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, Article 126a authorisations, certificates of registration or traditional herbal registrations, applicable to those products.

27

In regulation 37 (insertion of new regulations 45AA and 45AB (responsible persons: import)), in the inserted regulation 45AA—

(a) in paragraph (1), after “this regulation applies” insert “ to a licence holder in Great Britain ”;

(b) omit “and” at the end of paragraph (4)(a);

; 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.

28

In regulation 38 (amendment of regulation 45A (brokering in medicinal products))—

(a) for paragraph (2) substitute—

(2) For paragraph (1) substitute— (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) under Regulation (EC) No 726/2004, (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.

(b) for paragraph (3) substitute—

(3) In paragraph (2)— (a) after “paragraph (1)(b)” insert “ or (1A)(b) ”; (b) in sub-paragraphs (a) and (c), after “competent authority of a member State” insert “ or the licensing authority (as appropriate) ”.

29

In regulation 40 (amendment of regulation 45E (criteria of broker's registration))—

(a) for paragraph (a) substitute—

(a) for sub-paragraph (b)(i) substitute— (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

(b) for paragraph (b) substitute—

(b) in sub-paragraph (d)(iii), before “the batch number” insert “ where the sale or supply of the medicinal product is in Northern Ireland, ”.

30

In regulation 41 (amendment of regulation 45F (provision of information)), for the inserted sub-paragraph (b) substitute—

(b) in the case of a broker in— (i) Great Britain, either— (aa) the UK marketing authorisation holder, or (bb) where applicable, 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) Northern Ireland, either— (aa) the UK marketing authorisation holder, or (bb) where applicable, the EU marketing authorisation holder,

31

In regulation 42 (amendment of regulation 45M (criteria for importation, manufacture or distribution of an active substance)) for paragraph (2) substitute—

(2) For paragraph (2)(a) substitute— (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

32

In regulation 44 (amendment of regulation 45O (requirements for registration as an importer, manufacturer or distributor of an active substance))—

(a) for paragraph (2) substitute—

(2) For paragraph (1) substitute— (1) Where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance manufactured in Great Britain, a manufacturer in Great Britain must comply with the principles and guidelines of good manufacturing practice for active substances. (1A) Where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance manufactured in Northern Ireland, a manufacturer in Northern Ireland must comply with the principles and guidelines of good manufacturing practice for active substances.

(b) for paragraph (3) substitute—

(3) For paragraph (2) substitute— (2) Where principles and guidelines of good distribution practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance distributed in Great Britain, a distributor in Great Britain must comply with the principles and guidelines of good distribution practice for active substances. (2A) Where the Commission has adopted principles and guidelines of good distribution practice under the fourth paragraph of Article 47 of the 2001 Directive which applies to an active substance distributed in the Northern Ireland, a distributor in Northern Ireland must comply with the principles and guidelines of good distribution practice for active substances.

(4) In paragraph (3)— (a) for “the UK” substitute “ Northern Ireland ”; (b) for “from a third country” substitute “ into Northern Ireland from a country other than an EEA State ”; (c) for “exporting third country” in both places it occurs substitute “ exporting country ”; (d) in sub-paragraph (c)(ii), for “the Union” substitute “ Northern Ireland ”.

(d) after paragraph (4) insert—

(4A) After paragraph (3) insert— (3A) Without prejudice to regulation 37(4) and paragraph 9A of Schedule 8, where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance imported into Great Britain other than from Northern Ireland and where an active substance is so imported— (a) the importer must comply with good manufacturing practice and good distribution practice in relation to the active substance, (b) the active substances must have been manufactured in accordance with standards which are at least equivalent to good manufacturing practice, and (c) the active substances must be accompanied by a written confirmation from the competent authority of the exporting country of the following— (i) the standards of manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to good manufacturing practice, (ii) the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of standards of manufacturing practice at least equivalent to good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in Great Britain, and (iii) in the event of findings relating to non-compliance, information on such findings is supplied by the exporting country to the licensing authority without any delay.

(e) for paragraph (5) substitute—

(5) In paragraph (4)— (a) for “(3)(c) does” substitute “ (3)(c) and (3A)(c) do ”; (b) in sub-paragraph (a), after “Article 111b of the 2001 Directive” insert “ (in the case of an import into Northern Ireland) or paragraph (6) (in the case of an import into Great Britain) ”; (c) in sub-paragraph (b)(i), after “competent authority of a member State” insert “ or licensing authority (in the case of an import into Northern Ireland) or licensing authority or an appropriate authority responsible for the licensing of medicinal products in a country included in a list under paragraph (6) (in the case of an import into Great Britain) ”.

(f) in paragraph (6), in the inserted paragraph (6), for “the United Kingdom” in both places substitute “ Great Britain ”.

PART 3 — Amendment of Part 4 (amendment of Part 4 (requirement for authorisation))

33

In regulation 45 (amendment of regulation 46 (requirement for authorisation))—

(a) for paragraph (2)(b) and (c) substitute—

(b) after sub-paragraph (a) insert— (aa) an EU marketing authorisation;

(b) for paragraphs (4)(a) to (c) substitute—

(a) after “in force for the product” insert “ in the country in which the product is intended to be sold or supplied, or offered for sale or supply ”; (b) in sub-paragraph (a), before “marketing authorisation”, insert “ UK ”; and (c) after sub-paragraph (a) insert— (aa) an EU marketing authorisation;

34

In regulation 46 (amendment of regulation 47 (breach of requirement)), omit paragraph (3).

PART 4 — Amendment of Part 5 (amendment of Part 5 (marketing authorisations))

35

In regulation 47 (amendment of regulation 48 (application of Part 5))—

(a) in paragraph (2)(a)—

(i) for the definition of “EU reference medicinal product”, substitute—

“EU reference medicinal product” means a medicinal product which falls within paragraph (b)(ii) or (iii) of the definition of “reference medicinal product”;

(ii) after the definition of “EU reference medicinal product”, insert—

“excluded reference product” means— (a) a medicinal product authorised on the basis that it was a generic medicinal product; (b) a medicinal product authorised on the basis that one or more of the circumstances listed in Article 10(3) of the 2001 Directive or regulation 52(1)(b) applied; or (c) a biological medicinal product authorised on the basis that it did not meet a condition for being a generic medicinal product for any of the reasons described in Article 10(4) of the 2001 Directive or regulation 53A(1);

(b) in paragraph (2)(b), for the definition of “generic medicinal product”, substitute—

“generic medicinal product”, in relation to a reference medicinal product for an application for— (a) a UKMA(NI) or UKMA(UK), has the meaning given in Article 10(2)(b) of the 2001 Directive; (b) a UKMA(GB), means a medicinal product— (i) that has the same qualitative and quantitative composition in active substances as the reference medicinal product; (ii) that has the same pharmaceutical form as the reference medicinal product; and (iii) whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies;

“reference medicinal product” means— (a) in relation to an application for a UKMA(NI), a medicinal product— (i) authorised for sale or supply in Northern Ireland under regulation 49(1)(a), in accordance with the provisions of regulation 50; or (ii) in relation to which an EU marketing authorisation or a marketing authorisation granted by a member State pursuant to the 2001 Directive is or has been in force, but which is not an excluded reference product; (b) in relation to an application for a UKMA(GB), a medicinal product— (i) authorised under regulation 49(1)(a), in accordance with the provisions of regulation 50; (ii) in relation to which an EU marketing authorisation was in force on IP completion day, but in relation to which no UK marketing authorisation is in force because the holder of the EU marketing authorisation notified the licensing authority in accordance with paragraph 6(3) of Schedule 33A that it did not wish to be the holder of a converted EU marketing authorisation; or (iii) in relation to which an EU marketing authorisation had ceased to be in force before IP completion day for reasons not related to safety, quality or efficacy, but which is not an excluded reference product; (c) in relation to an application for a UKMA(UK), a medicinal product— (i) authorised under regulation 49(1)(a) for sale or supply in the whole of the United Kingdom, whether by virtue of one or more UK marketing authorisations, in accordance with the provisions of regulation 50; or (ii) in relation to which an EU marketing authorisation or a marketing authorisation granted by a member State pursuant to the 2001 Directive is or has been in force, but which is not an excluded reference product;

(d) in paragraph (3)—

(i) in the inserted paragraph (6)(b), for “regulations 51 to 53” substitute “ regulations 51 to 53B ”;

(ii) in the inserted paragraph (7), for “regulation 51(1) and (8)” substitute “ regulation 51A(1) and (6) ”;

(iii) in the inserted paragraph (8)(b), for “regulations 51 to 53” substitute “ regulations 51 to 53B ”;

(iv) in the inserted paragraph (9), for “regulation 51(1) and (8)” substitute “ regulation 51A(1) and (6) ”.

36

In regulation 48 (amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence))—

(a) in paragraph (3)—

(i) renumber the inserted paragraph (1A) as paragraph (1B);

(ii) before newly renumbered paragraph (1B) insert—

(1A) The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a UKMA(GB) only where— (a) there is already in place, or will be at the time the UKMA(GB) is granted, a marketing authorisation in respect of the product authorising sale or supply in Northern Ireland, (b) the applicant complies with the requirements in regulation 50(1A), and (c) the medicinal product satisfies the definition of qualifying Northern Ireland goods.

(iii) after newly renumbered paragraph (1B) insert—

(1C) A marketing authorisation or parallel import licence must state whether it is in force in— (a) the whole United Kingdom; (b) Great Britain only; or (c) Northern Ireland only, and in these Regulations the meaning of a reference to that authorisation or licence being “in force” is limited to that territory.

(b) for paragraph (4) substitute—

(4) For paragraph (3) substitute— (3) The applicant, where it is applying for— (a) a UKMA(NI)— (i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union; (ii) on any other basis, must be established in the United Kingdom; (b) a UKMA(GB)— (i) under the unfettered access route, must be established in Northern Ireland; (ii) other than under the unfettered access route, must be established in the United Kingdom; (c) a UKMA(UK), must be established in the United Kingdom.

(i) renumber paragraph (9) as paragraph (10);

(ii) before newly renumbered paragraph (10) insert—

(9) The application must include a statement indicating whether the authorisation or licence sought is for sale or supply of the product in— (a) the whole United Kingdom; (b) Great Britain only; or (c) Northern Ireland only.

37

In regulation 49 (amendment of regulation 50 (accompanying material))—

(a) after paragraph (1) insert—

(1A) After paragraph (1) insert— (1A) An applicant for the grant of a UK marketing authorisation for a relevant medicinal product must provide— (a) in the case of an application under the unfettered access route— (i) the material specified in Schedule 8C, and (ii) any material specified in Schedule 8 which is not included in the material specified in Schedule 8C, and (b) in all other cases, the material specified in Schedule 8, in relation to the product. (1B) After paragraph (3) insert— (3A) Paragraph (4) does not apply in respect of an application under the unfettered access route.

(b) for paragraph (2) substitute—

(2) For paragraph (4) substitute— (4) If any of the medicinal products to which the application for a UK marketing authorisation relates— (a) in the case of a UKMA(NI) or a UKMA(UK), is liable to be imported from a country other than an EEA State, or (b) in the case of a UKMA(GB), is liable to be imported, the material or information referred to in paragraph (3) may include an undertaking from the manufacturer of the product to comply with the matters set out in Schedule 9.

(i) for the inserted paragraph (5A) substitute—

(5A) The Secretary of State may by regulations in respect of Great Britain amend Schedule 8B (modifications of Annex I) in relation to a UKMA(GB) for the purpose of further modifying Annex I to the 2001 Directive in order to take account of scientific and technical progress.

(ii) in the inserted paragraph (5C), for “exit day” substitute “ IP completion day ”;

(d) after paragraph (4) insert—

(4A) In paragraph (6)— (a) for sub-paragraph (a), substitute— (a) regulation 51 (application for UKMA(NI) relating to generic medicinal products) (aa) regulation 51A (application for UKMA(GB) relating to generic medicinal products); (ab) regulation 51B (application for UKMA(UK) relating to generic medicinal products); (b) for sub-paragraph (b), substitute— (b) regulation 52 (application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc) (ba) regulation 52A (application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc); (bb) regulation 52B (application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc); (c) for sub-paragraph (c), substitute— (c) regulation 53 (application for UKMA(NI) relating to similar biological medicinal products) (ca) regulation 53A (application for UKMA(GB) relating to similar biological medicinal products); (cb) regulation 53B (application for UKMA(UK) relating to similar biological medicinal products);

38

In regulation 50 (amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation))—

(a) in paragraph (2)—

(i) in paragraph (a), after “in the United Kingdom” insert “ or a member State ”;

(ii) for paragraph (b) substitute—

(b) for sub-paragraph (b) substitute— (b) the country (which must be either the United Kingdom or a member State) in which the appropriately qualified person resides and carries out his or her tasks;

(iii) for paragraph (c) substitute—

(c) for paragraph (e) substitute— (e) a reference to the physical location where the pharmacovigilance system master file for the medicinal product can be accessed electronically, which must be in the United Kingdom.

(b) in paragraph (3), for the inserted paragraph 18, substitute—

(18) Where— (a) in the case of a UKMA(NI) or a UKMA(UK), an application for authorisation for the medicinal product to be placed on the market is under consideration in one or more member States— (i) a list of the member State or States concerned, and (ii) in relation to each such application, a copy of the summary of the product characteristics, and the package leaflet, proposed by the applicant; (b) in the case of a medicinal product for sale or supply in Great Britain, an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.

(4) In paragraph 19, for “a member State or by a third country” substitute “ , in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission ”.

(d) for paragraph (5) substitute—

(5) In paragraph 20, after “Where” insert “ , in the case of a medicinal product for sale or supply in Northern Ireland, ”.

(e) for paragraph (6) substitute—

(6) For paragraph 21 substitute— (21) Where an authorisation for the medicinal product to be placed on the market has been refused— (a) in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or (b) in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom, details of that decision and of the reasons for it.

(f) for paragraph (7) substitute—

(7) In paragraph 22 for “A copy of any” substitute “ In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any ”.

(g) for paragraph (8) substitute—

(8) For paragraph 23 substitute— (23) For medicinal products included on the list referred to— (a) in the case of a medicinal product for sale or supply in Northern Ireland, in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or (b) in the case of a medicinal product for sale or supply in Great Britain, in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.

(h) in paragraph (9), in the inserted paragraph 25A, after “advanced therapy medicinal product ” insert “ for sale or supply in Great Britain ”;

(i) in paragraph (10), in the inserted paragraph 36, after “advanced therapy medicinal product ” insert “ for sale or supply in Great Britain ”.

39

After regulation 51 (amendment of Schedule 8A (material to accompany an application for a parallel import licence)) insert—

(51A) Schedule 2A inserts a new Schedule 8C after Schedule 8B.

40

In regulation 53 (new regulation 50A to 50J (applications in relation to particular medicinal products))—

(a) in the inserted regulation 50A (requirement for certain applications to include results of paediatric investigation plan)—

(i) in paragraph (1)(a) and (b) for “UK marketing authorisation” substitute “ UKMA(GB) or UKMA(UK) ”; and

(ii) after paragraph (6) insert—

(7) In the case of an application for a UKMA(GB) under the unfettered access route, an agreed paediatric investigation plan in respect of the product's marketing authorisation in Northern Ireland applies also to that application as regards the UK marketing authorisation. (8) This regulation does not remove, in respect of an application for a UKMA(UK), the obligation also to comply with the requirements of the Paediatric Regulation in connection with the agreement of, and compliance with, an EU agreed paediatric investigation plan in relation to Northern Ireland.

(b) in the inserted regulation 50B(1) (agreement and modification of paediatric investigation plan), after “paediatric investigation plan” insert “ for the purposes of an application to which regulation 50A applies ”;

(i) in paragraph (1) for “UK marketing authorisation” substitute “ UKMA(GB) or UKMA(UK) ”;

(ii) after paragraph (4) insert—

(5) This regulation does not remove, in respect of an application for a UKMA(UK), the obligation also to comply with the requirements of the Paediatric Regulation in connection with the agreement of, and compliance with, an EU agreed paediatric investigation plan in relation to Northern Ireland.

(d) in the inserted regulation 50F(1)(a) and (b) (other applications including paediatric indications), for “UK marketing authorisation” substitute “ UKMA(GB) ”;

(e) in the inserted regulation 50G (applications relating to orphan medicinal products)—

(i) for paragraph (1) substitute—

(1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product— (a) in relation to which the applicant intends to demonstrate that the orphan criteria are met, and (b) which, in the case of an application for a UKMA(NI) or a UKMA(UK), is not a medicinal product designated as an orphan medicinal product in accordance with the Orphan Regulation.

(ii) in paragraph (2)(b)(i) and (c) for “the United Kingdom” substitute “ Great Britain ”;

(f) in the inserted regulation 50H(1) and (3) (applications relating to advanced therapy medicinal products), for “UK marketing authorisation” substitute “ UKMA(GB) ”;

(g) in the inserted regulation 50I (applications relating to conditional marketing authorisations)—

(i) in the heading, at the end insert “ for sale or supply in Great Britain only ”;

(ii) in paragraph (1), for “UK marketing authorisation” substitute “ UKMA(GB) ”.

41

For regulation 56 (substitution of regulation 51 (applications relating to generic medicinal products)) substitute—

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