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

In regulation 209 (amendment of regulation 270 (non-compliance with requirements of this Part)) for “for “marketing authorisation” to the end substitute “for “marketing authorisation,” substitute “ UK marketing authorisation, EU marketing authorisation, ”.

166

After regulation 209 (amendment of regulation 270 (non-compliance with requirements of this Part)) insert—

(209A) In regulation 271 for “268, 269” substitute “ 268, 268A, 269, 269A ”.

PART 14 — Amendment of Part 15 (amendment of Part 14 (advertising))

167

For regulation 211 (amendment of regulation 279 (products without a marketing authorisation)) substitute—

(211) For regulation 279 substitute— (279) (1) A person may not publish an advertisement in Great Britain for a medicinal product unless one of the following is in force for the product— (a) a UKMA(GB) or UKMA(UK); (b) a COR(GB) or COR(UK); or (c) a THR(GB) or THR(UK). (2) A person may not publish an advertisement in Northern Ireland for a medicinal product unless one of the following is in force for the product— (a) a UKMA(NI) or UKMA(UK); (b) a COR(NI) or COR(UK); (c) a THR(NI) or THR(UK); (d) an EU marketing authorisation; or (e) an Article 126a authorisation. (3) A person may not publish an advertisement in the whole United Kingdom for a medicinal product unless, in relation to that product— (a) one of the authorisations or registrations specified in paragraph (1) is in force in Great Britain; and (b) one of the authorisations or registrations specified in paragraph (2) is in force in Northern Ireland.

168

In regulation 212 (amendment of regulation 280 (general principles))—

• (a) for “280(1)” substitute “ 280 ”;

• (b) in paragraph (a)—

• (i) at the beginning, insert “ in paragraph (1) ”;

• (ii) for “UK marketing authorisation or” substitute “ UK marketing authorisation, EU marketing authorisation, ”;

• (c) for paragraph (b) substitute—

(b) after paragraph (1) insert— (1A) Where an advertisement mentioned in paragraph (1) relates to a product in relation to which there is a separate authorisation or registration in force in Great Britain and in Northern Ireland, it may not be published in the whole United Kingdom unless it complies with the particulars listed in the summary of the product characteristics in each of those authorisations or registrations (as the case may be).

169

In regulation 213 (amendment of regulation 281 (duties of authorisation holders and registration holders)) for paragraphs (b) and (c) substitute—

(b) omit “or” at the end of sub-paragraph (c); and (c) in sub-paragraph (d), after “for a medicinal product” insert— ; or (e) an EU marketing authorisation for a medicinal product.

170

After regulation 213 (amendment of regulation 281 (duties of authorisation holders and registration holders)) insert—

(213A) After regulation 284, insert— (284A) In the case of a medicinal product for sale or supply in Great Britain where the product concerned is not a prescription only medicine in Great Britain but is either— (a) a prescription only medicine in Northern Ireland; or (b) not authorised for sale or supply in Northern Ireland, any advertisement to the public must include a statement that the medicinal product is not available without a prescription, or is not available for sale or supply, in Northern Ireland (as the case may be).

171

For regulation 214 (amendment of regulation 293 (prohibition of supply to the public for promotional purposes) substitute—

(214) For regulation 293(1) substitute— (1) The holder of— (a) in the case of a medicinal product for sale or supply in Great Britain, a UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK); or (b) in the case of a medicinal product for sale or supply in Northern Ireland, a UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation or Article 126a authorisation, may not sell or supply a medicinal product for a promotional purpose to a person who is not qualified to prescribe medicinal products.

172

After regulation 214 (amendment of regulation 293 (prohibition of supply to the public for promotional purposes) insert—

(214A) In regulation 294, after paragraph (4) insert— (5) In the case of an advertisement which relates to a medicinal product for sale or supply— (a) in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland, (b) in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and (c) in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both— (i) the product for sale or supply in Great Britain, and (ii) the product for sale or supply in Northern Ireland.

173

For regulation 215 (amendment of regulation 295 (abbreviated advertisements)) substitute—

(215) In regulation 295— (a) for paragraph (2)(d) substitute— (d) the name and address of the holder— (i) in the case of a medicinal product for sale or supply in Great Britain, of the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK) for the medicinal product, or (ii) in the case of a medicinal product for sale or supply in Northern Ireland, the name and address of the holder of the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation, or Article 126a authorisation for the medicinal product, or the business name and address of the part of the holder's business that is responsible for the sale or supply of the medicinal product. (b) after paragraph (4) insert— (4A) In the application of this regulation to a medicinal product for sale or supply— (a) in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland, (b) in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and (c) in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both— (i) the product for sale or supply in Great Britain, and (ii) the product for sale or supply in Northern Ireland.

174

After regulation 215 (amendment of regulation 295 (abbreviated advertisements)) insert—

(215A) In regulation 298, for paragraph (5)(a) substitute— (a) is no larger than the smallest presentation of the product that is available for sale— (i) in the case of a medicinal product for sale or supply in Great Britain, in Great Britain, or (ii) in the case of a medicinal product for sale or supply in Northern Ireland, in Northern Ireland;

175

For regulation 216 (amendment of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply)) substitute—

(216) In Schedule 30— (a) in paragraphs 1, 2 and 6, for “marketing authorisation,” substitute “ UK marketing authorisation, EU marketing authorisation ”; (b) after paragraph 2 insert— (2A) In relation to an advertisement in Great Britain (other than an advertisement falling within the exception in regulation 296) where the medicinal product concerned is authorised under a UKMA(GB), a statement that the product concerned is authorised under a UKMA(GB).

176

In regulation 217 (amendment of regulation 299 (medical sales representatives)), for “for “marketing authorisation” to the end substitute “for “marketing authorisation,” substitute “ UK marketing authorisation, EU marketing authorisation ”.”.

177

After regulation 217 (amendment of regulation 299 (medical sales representatives)) insert—

(217A) In regulation 305— (a) for paragraph (3)(a) substitute— (a) state that the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2 and specify whether the incompatibility is insofar as the advertisement is for publication— (i) in Great Britain; (ii) in Northern Ireland; or (iii) in both Great Britain and Northern Ireland; (b) in paragraph (4), after “the advertisement” insert— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland (217B) In regulation 306— (a) in paragraph (2), after “Chapter 2” insert— and specify whether the incompatibility is insofar as the advertisement is for publication— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland (b) in paragraph (4)— (i) in sub-paragraph (a), after “Chapter 2” insert— insofar as the advertisement is for publication— (i) in Great Britain; (ii) in Northern Ireland; or (iii) in both Great Britain and Northern Ireland (ii) after “no longer applies” insert “ in Great Britain, Northern Ireland, or both Great Britain and Northern Ireland (as appropriate) ”; (c) in paragraph (5), after “Chapter 2” insert— insofar as the advertisement is for publication— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland (d) in paragraph (7)(b), after “no longer applies” insert— , and where that original notice related to both Great Britain and Northern Ireland, the new notice may be expressed to apply in relation to either of or both Great Britain and Northern Ireland (e) in paragraph (8), after “the advertisement” insert— (a) in Great Britain; (b) in Northern Ireland; or (c) in both Great Britain and Northern Ireland (217C) In regulation 307— (a) in paragraph (1)(a), after “subject of the notice” insert— in— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland (b) in paragraph (1)(b), after “that advertisement” insert— in— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland (c) in paragraph (2)(a), for “, either in full or in part; and” substitute— in respect of— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland, either in full or in part; and (217D) In regulation 311— (a) in paragraph (1)(a), for “Chapter 2; and” substitute— Chapter 2 in respect of— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland; and (b) in paragraph (3), after “ the advertisement” insert— in— (i) Great Britain; (ii) Northern Ireland; or (iii) both Great Britain and Northern Ireland, as the case may be.

PART 15 — Amendment of Part 16 (amendment of Part 15 (British Pharmacopoeia))

178

In regulation 218 (amendment of regulation 321 (specified publications)), for paragraph (b) substitute—

(b) after sub-paragraph (c) insert— (ca) an EU marketing authorisation;

PART 16 — Amendment of Part 17 (amendment of Part 16 (enforcement))

179

Omit regulation 219 (amendment of regulation 322 (validity of proceedings)).

180

In regulation 221 (amendment of regulation 327 (powers of inspection, sampling and seizure))—

• (a) in paragraph (2), for sub-paragraphs (b) and (c) substitute—

(b) after paragraph (v), insert— (va) an EU marketing authorisation;

• (b) for paragraph (3) substitute—

(3) In paragraph (2)(g), after paragraph (iv) insert— (iva) the requirements of Schedule 12A (further provision as to the performance of pharmacovigilance activities);

• (c) omit paragraphs (4) and (5).

181

In regulation 222 (amendment of regulation 331 (findings and reports of inspections))—

• (a) for paragraph (2) substitute—

(2) In paragraph (1)— (a) for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation ”; (b) in sub-paragraph (c), at the beginning, insert “ in the case of a product authorised under a UKMA(NI) or UKMA(UK), ”.

• (b) for paragraph (3) substitute—

(3) In paragraph (4)— (a) for sub-paragraph (b) substitute— (b) the guidelines on good distribution practice— (i) in the case of Great Britain, published under, or that apply by virtue of, regulation C17; (ii) in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive; (b) after sub-paragraph (c) insert— (d) Schedule 12A; and (e) the Implementing Regulation (as defined in regulation 177(5)).

182

In regulation 223 (insertion of regulation 331A (guidelines on inspections)), in the inserted regulation 331A(3), for “exit day” substitute “ IP completion day ”.

PART 17 — Amendment of Part 18 (amendment of Part 17 (miscellaneous and general))

183

Before regulation 224 (amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)) insert—

(224ZA) In regulation 335(6)(b) for “268 and 269” substitute “ 268, 268A, 269 and 269A ”. (224ZB) In regulation 336(3)(b) for “268 and 269” substitute “ 268, 268A, 269 and 269A ”. (224ZC) In regulation 340(5) for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “ 268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 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) ”. (224ZD) In paragraph 3(10) of Schedule 32 for “268 (offences relating to packaging and package leaflets: authorisation holders), 269 (offences relating to packaging and package leaflets: other persons)” substitute “ 268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 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) ”.

184

For regulation 224 (amendment of regulation 341 (decisions under the Human Medicines Regulations 2012)) substitute—

(224) In regulation 341(4)— (a) in paragraph (a), insert “ UK ” before “marketing authorisation”; (b) after paragraph (a), insert— (aa) a decision to grant or revoke an EU marketing authorisation;

185

In regulation 225 (insertion of regulation 344A (modifications to deal with serious shortages) and 344B (regulation making powers)), in the inserted regulation 344A(5) for “exit day” substitute “ IP completion day ”.

186

For regulation 226 (amendment of regulation 345 (immunity from civil liability)) substitute—

(226) In regulation 345(5), for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation ”.

187

In regulation 227 (amendment of regulation 346 (Secretary of State to carry out a review of certain provisions))—

• (a) in paragraph (a), for “paragraphs (iia)” to “(xxviiij)” substitute “ paragraph (xixa) ”;

• (b) in paragraph (b), for “paragraphs (ia) and (ivab)” substitute “ paragraph (ia) ”.

PART 18 — Amendment of Schedule 1 (amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016)

188

In Schedule 1 (amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016)—

• (a) before paragraph 1 insert—

(1ZA) After regulation 10 insert— (10A) (1) The fee payable in connection with a meeting mentioned in any of regulations 4 to 10 is waived where the person by whom the fee would otherwise be payable is established in the United Kingdom and is— (a) a small company, or (b) a medium-sized company. (2) In this regulation, “small company” and “medium-sized company” have the same meanings as in sections 382 and 465 of the Companies Act 2006 respectively.

• (b) in paragraph 1 (amendment of regulation 19 (capital fees for applications for variations of authorisations)), after sub-paragraph (a) insert—

(aa) after paragraph (1)(d), insert— (e) under Commission Regulation (EC) No 1234/2008 for the variation of a UKMA(UK) or UKMA(NI).

• (c) in paragraph 2 (insertion of regulations 19A–19F (fees for plasma master files, vaccine antigen master files, post-authorisation safety studies, major safety reviews, periodic safety update reports and batch testing))—

• (i) in the inserted regulation 19C (fees for assessment of post-authorisation safety studies)—

• (aa) for paragraph (2) substitute—

(2) The fee payable by the holder of a marketing authorisation upon submission of the draft protocol for a post-authorisation safety study in accordance with regulation 199(2) of the Human Medicines Regulations— (a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding draft protocol has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £734; (b) where sub-paragraph (a) does not apply and— (i) the study is to be conducted in the United Kingdom only; or (ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only, is £8,309; and (c) in any other case, is £734.

• (bb) for paragraph (3) substitute—

(3) The fee payable by the holder of a marketing authorisation upon submission of the final study report for a post-authorisation safety study in accordance with regulation 201(2) of the Human Medicines Regulations— (a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding final study report has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £734; (b) where sub-paragraph (a) does not apply and— (i) the study is to be conducted in the United Kingdom only; or (ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only, is £8,309; and (c) in any other case, is £734.

• (ii) in new regulation 19D (fee for carrying out a major safety review), in paragraph (1)—

• (aa) before “marketing authorisation” insert “ United Kingdom ”;

• (bb) after “a set of” insert “ such ”;

• (d) in paragraph 3 (amendment of regulation 23 (applications for multiple variations)), for sub-paragraphs (2) to (4) substitute—

(2) For paragraph (3)(b)(i) substitute— (i) have agreed— (aa) in the case of a UKMA(NI) or UKMA(UK), in consultation with member States concerned and in accordance with Article 7(2)(c) of Commission Regulation (EC) No 1234/2008, should be subject to the procedure for grouping of variations within the meaning of that Article; (bb) in the case of a UKMA(GB), should be subject to the procedure for grouping of variations within the meaning of paragraph 5(2)(c) of Schedule 10A to the Human Medicines Regulations; and (3) For paragraph (6) substitute— (6) In a case where a recommendation on the classification of a variation is made in accordance with— (a) in the case of a UKMA(NI) or UKMA(UK), Article 5 of Commission Regulation (EC) No 1234/2008; or (b) in the case of a UKMA(GB), paragraph 3 of Schedule 10A to the Human Medicines Regulations, the fee payable for the application made in respect of that variation is the appropriate fee for the classification given to the variation or, as the case may be, the appropriate fee which arises as a consequence of the classification given to the variation. (4) In paragraph (7)— (a) in the definition of “Major Variation (Type II) Group Application”— (i) for sub-paragraph (b) substitute— (b) subject to sub-paragraph (c), the variations fall— (i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations; (ii) for sub-paragraph (c)(i) substitute— (i) of a kind referred to— (aa) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008; (bb) in the case of UKMA(GB), in paragraph 5(3)(a) or (c) of Schedule 10A to the Human Medicines Regulations; (b) in the definition of “Major Variation (Type II) Complex Group Application”— (i) for sub-paragraph (b) substitute— (b) subject to sub-paragraph (c), the variations fall— (i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations; (ii) for sub-paragraph (c)(i) substitute— (i) of a kind referred to— (aa) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008; (bb) in the case of a UKMA(GB), in paragraph 5(3)(a) or (c) of Schedule 10A to the Human Medicines Regulations; (c) in the definition of “Major Variation (Type II) Extended Complex Group Application”— (i) for sub-paragraph (b) substitute— (b) subject to sub-paragraph (c), the variations fall— (i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations; (ii) for sub-paragraph (c) substitute— (c) the variations do not include a variation of a kind referred to— (i) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 of Annex III to Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), in paragraph 5(3)(a) of Schedule 10A to the Human Medicines Regulations; and (d) for the definition of “major variation of type II” substitute— “major variation of type II”— (a) in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(3) of Commission Regulation (EC) No 1234/2008; and (b) in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; (e) in the definition of “Minor Variation (Type IB) Group Application”— (i) for sub-paragraph (b) substitute— (b) subject to sub-paragraph (c), the variations fall— (i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations; (ii) for sub-paragraph (c)(i) substitute— (i) a variation of a kind referred to— (aa) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 or paragraph 2 of Annex III of Commission Regulation (EC) No 1234/2008; (bb) in the case of a UKMA(GB), in paragraph 5(3)(a) or (b) of Schedule 10A to the Human Medicines Regulations; or (f) for the definition of “minor variation of type IA” substitute— “minor variation of type IA”— (a) in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(2) of Commission Regulation (EC) No 1234/2008; and (b) in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; (g) for the definition of “minor variation of type IB” substitute— “minor variation of type IB”— (a) in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(5) of Commission Regulation (EC) No 1234/2008; and (b) in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and (h) in the definition of “work sharing”, after “means” insert “ , in the case of a UKMA(NI) or UKMA(UK), ”.

• (e) in paragraph 4 (insertion of regulation 27A (fee for renewals of a marketing authorisation)), in the inserted regulation 27A, after “renewal of a marketing authorisation” insert “ in the case of a product for sale or supply in Great Britain ”;

• (f) in paragraph 6 (amendment of Schedule 1 (general interpretation provisions)), in sub-paragraph (a)—

• (i) before paragraph (i) insert—

(ai) in the definition of “marketing authorisation”, in paragraph (a) after “Human Medicines Regulations” insert “ (and a reference to a UKMA(GB), UKMA(NI) or UKMA(UK) should be construed in accordance with those Regulations) ”;

• (ii) in paragraph (iv), after the definition of “the EMA” insert—

“under the unfettered access route” has the meaning given by regulation 8(1) of the Human Medicines Regulations;

• (g) in paragraph 7 (amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates))—

• (i) for sub-paragraph (2) substitute—

(2) For paragraph 4(a) substitute— (a) for an extension of a marketing authorisation— (i) in the case of a UKMA(NI) or UKMA(UK), within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008; or (ii) in the case of a UKMA(GB), within the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and

• (ii) in sub-paragraph (3)—

• (aa) in paragraph (a), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute—

(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(5) of Commission Regulation (EC) No 1234/2008; (b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

• (bb) in paragraph (b), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute—

(i) in the case of a UKMA(NI) or UKMA(UK), Article 2(4) of Commission Regulation (EC) No 1234/2008; (ii) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

• (cc) in paragraph (c), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute—

(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(2) of Commission Regulation (EC) No 1234/2008; (b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

• (iii) in sub-paragraph (4)—

• (aa) in paragraph (a), for “substitute” to the end, substitute “substitute in the case of a UKMA(NI) or UKMA(UK), paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to Commission Regulation (EC) No 1234/2008 applies or, in the case of a UKMA(GB), sub-paragraph (a) (changes to active substances) or sub-paragraph (b) (changes to strength, pharmaceutical form and route of administration) of the definition of “extension of a UK marketing authorisation” in paragraph 1 of Schedule 10A to the Human Medicines Regulations applies ”;

• (bb) in paragraph (b), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute “ in the case of a UKMA(NI) or UKMA(UK), Article 2(3) of Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations ”;

• (cc) in paragraph (c), for “paragraph 1 of Schedule 10A to the Human Medicines Regulations” substitute “ in the case of a UKMA(NI) or UKMA(UK), Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations ”;

• (iv) in sub-paragraph (5), for the table substituted in paragraph 24, substitute—

Column 1Kind of application	Column 1Kind of application	Column 2Fee payable
1. Major Application	1. Major Application
(a)	in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies	£29,732
(b)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£62,421
(c)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£62,421
(d)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for UKMA(GB)	£62,421
(e)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£18,437
(f)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£62,421
(g)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£18,437
(h)	in any other case	£92,753
2. Complex application	2. Complex application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£17,330
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£17,330
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£17,330
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£10,443
(e)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£17,330
(f)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£10,443
(g)	in any other case	£25,643
3. Standard application	3. Standard application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£6,350
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£6,350
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£6,350
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£5,783
(e)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£6,350
(f)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£5,783
(g)	in any other case	£9,402
4. Simple application	4. Simple application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£2,564
(b)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£2,564
(c)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£2,564
(d)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive	£2,564
(e)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£2,564
(f)	in any other case	£2,564
5. Parallel import licence applications	5. Parallel import licence applications
(a)	in respect of a simple parallel import licence	£1,792
(b)	in respect of a standard parallel import licence	£6,663
(c)	in respect of a complex parallel import licence	£18,180
6. Change of ownership application	6. Change of ownership application	£442

• (v) in sub-paragraph (6), in the inserted paragraph 24A—

• (aa) in the heading, for “exit day” substitute “ IP completion day ”;

• (bb) in sub-paragraph (1), for “exit day” substitute “ IP completion day ”;

• (vi) after paragraph (8) insert—

(8A) After paragraph 28 (application for multiple authorisations) insert— (28A) (1) Where an applicant for a United Kingdom marketing authorisation submits material in accordance with regulation 50(5) of the Human Medicines Regulations for pre-assessment by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is— (a) £23,188.25 in respect of Module 3 (chemical, pharmaceutical and biological information); (b) £23,188.25 in respect of Module 4 (non-clinical reports); (c) £23,188.25 in respect of Module 5 (clinical study reports). (2) Where an applicant for a United Kingdom marketing authorisation for a similar biological medicinal product submits material in accordance with regulations 53, 53A or 53B of the Human Medicines Regulations for pre-assessment of a complex abridged application by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is— (a) £4,332.50 in respect of Module 3 (chemical, pharmaceutical and biological information); (b) £4,332.50 in respect of Module 4 (non-clinical reports); (c) £4,332.50 in respect of Module 5 (clinical study reports). (3) The fee payable under sub-paragraphs (1) and (2) must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of the fee. (4) Where a fee has been paid under this paragraph, any fee payable under regulation 12(1) in connection with an application for the grant of a United Kingdom marketing authorisation in respect of the same product is reduced by the amount paid under this paragraph provided that no further assessment of the Module concerned is required.

• (vii) for sub-paragraph (9) substitute—

(9) In paragraph 38— (a) in sub-paragraph (4)(b), after “Commission Regulation (EC) 1234/2008” insert “ and of marketing authorisations in force in Great Britain ”; (b) after sub-paragraph (6)— (i) for Table 1 substitute—

Column 1Kind of variation	Column 1Kind of variation	Column 2Fee payable
1. Application for a single kind variation	1. Application for a single kind variation
(a)	Type IB Application	£277
(b)	Type II Application	£277
(c)	Type II Complex Variation Application	£2,493
(d)	Extended Type II Complex Variation Application	£7,693
2. Applications for a Group	2. Applications for a Group
(a)	Minor Variation (Type IB) Group Application	£277
(b)	Major Variation (Type II) Group Application	£496
(c)	Major Variation (Type II) Complex Group Application	£2,703
(d)	Major Variation (Type II) Extended Complex Group Application	£7,883

(ii) in Table 2—
  (aa) in the heading to the table, after “Commission Regulation [(EC) No 1234/2008](https://www.legislation.gov.uk/european/regulation/2008/1234)” insert “ and of marketing authorisations in force in Great Britain ”;
  (bb) after row 8 insert—

9 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related UKMA(NI) for the same product	£nil
10 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related European Union marketing authorisation for the same product	Apply fees and fee categories in Table 1
11 Variation of a UKMA(UK) or a UKMA(GB) which was granted following an application other than an application made under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive, provided a corresponding variation has been approved to the related marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in Table 1
12 Variation of a UKMA(GB) which was granted following an application where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), provided a corresponding variation has been approved to the related European Union marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in table 1

• (viii) in sub-paragraph (12), in the inserted paragraph 40A—

• (aa) in the heading for “exit day” substitute “ IP completion day ”;

• (bb) in subparagraph (1) for “exit day” substitute “ IP completion day ”;

• (ix) in sub-paragraph (13)—

• (aa) for the inserted paragraph 56 substitute—

(56) Unless paragraph 57 applies, the fee payable under regulation 27A in connection with an application for the renewal of a United Kingdom marketing authorisation is— (a) in respect of an application for renewal of a UKMA(GB) granted under the unfettered access route, £747; (b) in respect of an application for renewal of a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), £747; (c) in all other cases, £9,682.

• (bb) for the inserted paragraph 57(2) substitute—

(2) The fee payable under regulation 27A for applications to which sub-paragraph (1) applies is— (a) in respect of applications for renewal of more than one UKMA(GB) granted under the unfettered access route or UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding renewal application has been made to the related European Union marketing authorisation or UKMA(NI) for the same product— (i) £747 for the first application considered by the licensing authority; and (ii) £747 for each other application; (b) in all other cases— (i) £9,682 for the first application considered by the licensing authority; and (ii) £747 for each other application.

• (h) after paragraph 8 insert—

(8A) In Schedule 6, in paragraph 2, for “entry 1(f)” substitute “ entry 1(h) ”.

189

In Schedule 2 (insertion of new Schedule 8B (modifications of Annex I to the 2001 Directive)), in the inserted Schedule 8B—

• (a) in the entry in the table for “Part I, paragraph 5.2(a)”, in the corresponding modification, for “regulations 51 to 56” substitute “ regulations 51A, 52A, 53A and 54 to 56 ”;

• (b) in the entry in the table for “Part I, paragraph 5.2.1, second paragraph”, in the corresponding modification, for “regulation 51” substitute “ regulation 51A ”;

• (c) in the entry in the table for “Part II, paragraph 2(b)”, in the corresponding modification, for “regulation 51” substitute “ regulation 51A ”;

• (d) in the entry in the table for “Part II, paragraph 4, first paragraph”, in the corresponding modification, for “regulation 53” substitute “ regulation 53A ”.

PART 19 — Insertion of Schedule 2A (insertion of new Schedule 8C (material to accompany an application for a UK marketing authorisation under the unfettered access route))

190

After Schedule 2 (insertion of new Schedule 8B (modifications of Annex I to the 2001 Directive)) insert—

SCHEDULE 2A (1) After Schedule 8B to the Human Medicines Regulations 2012, insert— SCHEDULE 8C (1) A copy of the application submitted in connection with the granting of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland. (2) A copy of all material submitted in support of the application for the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland. (3) A copy of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.

PART 20 — Amendment of Schedule 4 (insertion of new Schedule 9A)

191

In Schedule 4 (insertion of new Schedule 9A), in the inserted Schedule 9A, for “the United Kingdom”, in each place it occurs (including the heading to paragraph 1) other than in paragraph 2(3), substitute “ Great Britain ”.

PART 21 — Amendment of Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities))

192

In Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities)), in the inserted Schedule 12A—

• (a) in paragraphs 1(3), 12(5), 16(3), 22(1)(d) and 30(g), for “UK marketing authorisation” substitute “ UKMA(GB) ”;

• (b) in paragraph 2(a)—

• (i) at the end of paragraph (iii) omit “and”;

• (ii) in paragraph (iv), for “pharmacovigilance;” substitute “ pharmacovigilance, and ”;

• (iii) after paragraph (iv) insert—

(v) responsibilities and contact details of the nominated person (where a person is nominated under regulation 182(2A));

• (c) in paragraph 2(d), for “handing” substitute “ handling ”;

• (d) omit paragraph 4(4);

• (e) in paragraph 7—

• (i) omit sub-paragraph (1);

• (ii) in sub-paragraph (2)—

• (aa) after “qualified person” insert “ and nominated person (where a person is nominated under regulation 182(2A)) ”;

• (bb) for “has” substitute “ have ”.

PART 22 — Amendment of Schedule 7 (insertion of new Schedule 33A (Transitional Provision))

193

In Schedule 7 (insertion of new Schedule 33A (Transitional Provision)), in the inserted Schedule 33A—

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

• (b) for “21 months”, in each place it occurs, substitute “ 24 months ”;

• (c) for “33 months”, in each place it occurs, substitute “ 36 months ”;

• (d) for paragraph 6(2)(a) substitute—

(a) insofar as it authorises sale or supply of a medicinal product in Great Britain, has effect on and after IP completion day as a UKMA(GB) granted under regulation 49(1) of these Regulations (but, insofar as it authorises sale or supply of a medicinal product in Northern Ireland, continues to operate in Northern Ireland as an EU marketing authorisation); and

• (e) in paragraph 6(4)(f), for “regulation 51(1) and (2)” substitute “ regulation 51A(1) and (6) ”;

• (f) before paragraph 26 insert—

(26ZA) (1) This paragraph applies in relation to a UK marketing authorisation granted by the licensing authority under Chapter 4 of Title III to the 2001 Directive that was in force immediately before IP completion day. (2) A UK marketing authorisation to which this paragraph applies— (a) has effect on and after IP completion day as a UKMA(UK) granted under regulation 49(1) of these Regulations; and (b) is treated as including a statement that it is in force in the whole United Kingdom for the purposes of regulation 49(1C).

• (g) in paragraph 26(1)(a)—

• (i) omit “or” at the end of subparagraph (iii);

• (ii) for “and” at the end of subparagraph (iv) substitute—

or (v) is deemed to hold a parallel import licence under paragraph 28(2); and

• (h) in paragraph 26(2), after “continues to apply to a person” insert “ where the UK marketing authorisation or parallel import licence authorises sale or supply of the medicinal product in Great Britain ”;

• (i) in paragraphs 27(1), 33(1), 45(1) and 50(1), after “offence relating to packaging and package leaflets” insert “ in Great Britain ”;

• (j) after paragraph 27 insert—

(27A) (1) This paragraph applies in relation to a parallel import licence granted by the licensing authority that was in force immediately before IP completion day. (2) A parallel import licence to which this paragraph applies— (a) has effect on and after IP completion day as a parallel import licence in force in the whole United Kingdom granted under regulation 49(1) of these Regulations; and (b) is treated as including a statement that it is in force in the whole United Kingdom for the purposes of regulation 49(1C).

• (k) in paragraph 28(2), after “granted under Part 5” insert “ , in force in Great Britain only, ”;

• (l) in paragraph 29, after sub-paragraph (7) insert—

(8) This paragraph, with the exception of sub-paragraphs (3) and (4), applies equally to a medicinal product imported into the United Kingdom pursuant to a parallel import licence and accordingly any reference in this paragraph (other than in this sub-paragraph) to— (a) a marketing authorisation or a UK marketing authorisation is to be read as a reference to a parallel import licence for a medicinal product, and (b) the holder of a UK marketing authorisation is to be read as a reference to the holder of a parallel import licence.

• (m) after paragraph 29 insert—

(29A) (1) Sub-paragraph (2) applies where— (a) an EU marketing authorisation was in force before IP completion day, (b) that authorisation is in force on IP completion day (whether or not it is suspended); and (c) that authorisation is for a medicinal product of a type that is specified in regulation 60B(2) (requirement to submit samples and other information to the appropriate authority). (2) Where this sub-paragraph applies, the EU marketing authorisation is deemed to be subject to the batch testing requirement in regulation 60B on and after IP completion day. (3) Sub-paragraph (4) applies where a holder of an EU marketing authorisation has, before IP completion day, submitted to a competent authority of an EEA State samples for testing from a batch of a medicinal product (“the relevant batch”) that— (a) is the subject of that authorisation; and (b) is of a type specified in regulation 60B(2). (4) Where this sub-paragraph applies, the holder of the EU marketing authorisation is deemed to have satisfied the batch testing requirement in regulation 60B in respect of the relevant batch if, before IP completion day— (a) the competent authority of that EEA State examines the sample from the relevant batch; and (b) that authority declared it to be in conformity with the approved specifications (within the meaning of Article 114 of the 2001 Directive) before IP completion day. (5) Sub-paragraphs (5) and (6) of paragraph 29 apply in relation to the appropriate authority's management of the list published under regulation 60A(5) for the purposes of this paragraph and regulation 60B.

• (n) in paragraph 41, in sub-paragraphs (3), (5) and (8)—

• (i) in paragraphs (a) and (b), omit “with which the United Kingdom concurred”;

• (ii) in paragraph (c), omit “, or where such an opinion has been given but the United Kingdom recorded a divergent opinion,”;

• (o) after paragraph 41 insert—

(41A) Where a relevant medicinal product is subject to a global marketing authorisation as described in Article 6 of the 2001 Directive before IP completion day, a paediatric investigation plan does not need to be carried out in relation to that product.

• (p) omit Part 7 (transitional provision in relation to orphan medicinal products);

• (q) in paragraph 44(2), after “continues to apply to a person” insert “ , in relation to a certificate of registration in force in Great Britain, ”;

• (r) in paragraph 49(2), after “continues to apply to a person” insert “ , only in relation to a registration in force in Great Britain, and ”;

• (s) in paragraph 52(1), after “traditional herbal registration” insert “ to be in force in Great Britain only ”;

• (t) in paragraph 53, after “traditional herbal registration” insert “ in force in Great Britain only ”;

• (u) in paragraph 55(1)(a), after “traditional herbal registration” insert “ to be in force in Great Britain only ”;

• (v) omit paragraph 56;

• (w) omit paragraph 57;

• (x) in paragraph 58—

• (i) in sub-paragraph (1)(a), after “specified matter” insert “ in relation to a UKMA(GB) or a THR(GB) ”;

• (ii) in sub-paragraph (2), for “UK marketing authorisation or traditional herbal registration” substitute “ UKMA(GB) or THR(GB) ”;

• (iii) in sub-paragraph (7)(a), after “specified matter” insert “ in relation to a UKMA(GB) or a THR(GB) ”;

• (y) in paragraph 59—

• (i) in sub-paragraph (1)(a), after “holder” insert “ of a UKMA(GB) or a THR(GB) ”;

• (ii) in sub-paragraph (2)—

• (aa) for “revocation” substitute “ amendment ”;

• (bb) for “UK marketing authorisation or traditional herbal registration” substitute “ UKMA(GB) or THR(GB) ”;

• (iii) in sub-paragraph (3)(a), after “holder” insert “ of a UKMA(GB) or a THR(GB) ”;

• (z) in paragraph 60—

• (i) in sub-paragraph (1)(b), after “holder” insert “ of a UKMA(GB) or a THR(GB) ”;

• (ii) in sub-paragraph (2), after “holder” insert “ of a UKMA(GB) or a THR(GB) ”;

• (iii) in sub-paragraph (3)(a), after “holder” insert “ of a UKMA(GB) or a THR(GB) ”;

• (iv) in sub-paragraph (5)(a), after “holder” insert “ of a UKMA(GB) or a THR(GB) ”;

• (aa) in paragraph 61—

• (i) in sub-paragraphs (2)(a) and (b), after “holder” insert “ of a UKMA(GB) or a THR(GB) ”;

• (ii) in sub-paragraph (4), for “revocation” substitute “ amendment ”;

• (iii) in sub-paragraph (5)(b), after “holder” insert “ of a UKMA(GB) or a THR(GB) ”;

• (iv) in sub-paragraph (6)—

• (aa) for “revocation” substitute “ amendment ”;

• (bb) in paragraph (b), after “holder” insert “ of a UKMA(GB) or a THR(GB) ”.

PART 23 — Amendment of Schedule 8 (consequential provision)

194

In Schedule 8 (consequential provision)—

• (a) in paragraph 4 (amendment of the Prescription Only Medicines (Human Use) Order 1997)—

• (i) for “In article 5(1)” substitute “ After article 5(1) ”; and

• (ii) for “insert “ UK ” before “marketing authorisation” ” substitute “insert—

(1A) In paragraph (1) “marketing authorisation” means— (a) in relation to medicinal products for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK); (b) in relation to medicinal products for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK), an EU marketing authorisation or a parallel import licence.

• (b) in paragraph 8 (amendment of the Blood Safety and Quality Regulations 2005)—

• (i) for “as if reference” substitute “ as if the reference ”;

• (ii) after “within the meaning of” insert “ paragraph (a) of the definition of that term in ”;

• (c) for paragraph 7 (amendment of the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003) substitute—

(7) In regulation 1(2) of the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 (citation, commencement and interpretation), for the definition of “unlicensed product” substitute— “unlicensed product” means— (a) in the case of a product to be imported or marketed in Great Britain, a medicinal product for human use, other than an excluded medicine, in respect of which no UKMA(GB), UKMA(UK), THR(UK) or THR(GB) has been granted; (b) in the case of a product to be imported or marketed in Northern Ireland, a medicinal product for human use, other than an excluded medicine, in respect of which no UKMA(NI), UKMA(UK), THR(UK) or THR(NI), EU marketing authorisation or Article 126a authorisation has been granted, and “Article 126a authorisation”, “EU marketing authorisation”, “THR(GB)”, “THR(NI)”, “THR(UK)”, “UKMA(GB)”, “UKMA(NI)” and “UKMA(UK)” have the meanings given in regulation 8 of the 2012 Regulations;.;

• (d) in paragraph 16 (amendment of the Branded Health Service Medicines (Costs) Regulations 2018)—

• (i) omit sub-paragraph (2)(a) to (d);

• (ii) omit sub-paragraph (3);

• (iii) omit sub-paragraph (4)(a)(i);

• (iv) for sub-paragraph (4)(a)(ii) substitute—

(ii) in sub-paragraph (b), after “Article 21” insert “ or regulation 64(6) of the 2012 Regulations ”; and

• (v) omit sub-paragraph (4)(b);

• (vi) omit sub-paragraph (5);

• (vii) omit sub-paragraph (6).

PART 24 — Amendment of Schedule 9 (retained EU law: revocations)

195

In Schedule 9 (retained EU law: revocations), in paragraph 1, after sub-paragraph (ii) insert—

(jj) Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use.

SCHEDULE 3 — Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

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

1

In Schedule 1—

• (a) omit paragraphs 2 to 6;

• (b) omit paragraph 8;

• (c) in paragraph 10, omit sub-paragraphs (3) and (4).

Signed

Signed by authority of the Secretary of State for Health and Social Care

Edward Argar — Minister of State, — 2020-12-03

We consent

Maggie Throup — Rebecca Harris — Two of the Lords Commissioners of Her Majesty's Treasury — 2020-12-08

Explanatory note

(This note is not part of the Regulations)

Footnotes

Editorial notes