The Human Medicines Regulations 2012

[F1 PART 4 U.K. Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices

Textual Amendments

F1 Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)

Status of certain UK marketing authorisations granted before IP completion day U.K.

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).

Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day U.K.

26.— (1) Subject to sub-paragraphs (2) and (3), any person—

(a) who—

(i) holds a UK marketing authorisation immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(ii) holds a parallel import licence immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(iii) has made an application for, or to renew, a UK marketing authorisation or parallel import licence before IP completion day, which has not been determined before that date,

(iv) makes such an application on or after IP completion day but before the end of the transitional period; or

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

(b) who was, immediately before IP completion day, established in an EEA State and remains established there on and after IP completion day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 49(3), 66(2) or 66A(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) But sub-paragraph (1) continues to apply to a person where the UK marketing authorisation or parallel import licence authorises sale or supply of the medicinal product in Great Britain only if the person has notified the licensing authority in writing of—

(a) a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the UK marketing authorisation or parallel import licence, or application for a UK marketing authorisation or parallel import licence (as the case may be), during the transitional period; and

(b) that individual's address, telephone number and email address.

(3) A person must notify the licensing authority under sub-paragraph (2)—

(a) where sub-paragraph (1)(a)(i) to (iii) applies, within the period of 4 weeks beginning with IP completion day; or

(b) where sub-paragraph (1)(a)(iv) applies, at the time of making the application.

(4) This paragraph does not apply to a UK marketing authorisation that is a converted EU marketing authorisation within the meaning of paragraph 6.

(5) In this paragraph “the transitional period” means the period of 24 months beginning with IP completion day.

Temporary exemption as to packaging requirements: change of place of establishment U.K.

27.— (1) Subject to sub-paragraph (2), a person to whom paragraph 26 applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc) during the transitional period to the extent that—

(a) the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet (as the case may be), do not include the correct information as to—

(i) the name and address of the holder of the UK marketing authorisation, or, where applicable, the name of that holder's representative,

(ii) the number of the UK marketing authorisation, or

(iii) the name and address of the manufacturer of the product; and

(b) the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i) the UK marketing authorisation holder has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 49(3), and

(ii) the information specified in paragraph (a)(i) to (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a) the packaging and package leaflet met the requirements of Part 13 as to the matters specified in paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b) the UK marketing authorisation holder, having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

(3) In this paragraph “the transitional period” means the period of 36 months beginning with IP completion day.

Status of parallel import licences granted before IP completion day U.K.

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).

Conversion of parallel distribution notices in to parallel import licences U.K.

28.— (1) Sub-paragraph (2) applies where—

(a) a person holds a parallel distribution notice, issued by the EMA, for a medicinal product in respect of which there is an EU marketing authorisation;

(b) that distribution notice, and that EU marketing authorisation, are in force immediately before IP completion day; and

(c) that parallel distribution notice specifies the United Kingdom as a member state of destination in respect of that medicinal product.

(2) Subject to sub-paragraph (3), a person who falls within sub-paragraph (1) is deemed, on and after IP completion day, to have a parallel import licence granted under Part 5, in force in Great Britain only, in respect of the medicinal product specified in the parallel distribution notice.

(3) A person who falls within sub-paragraph (1) continues to hold a parallel import licence pursuant to sub-paragraph (2) only if that person notifies the licensing authority—

(a) before the end of the period of 21 days beginning with IP completion day, of each medicinal product, and each country from which it is intended to import that product on or after IP completion day; and

(b) of any other information that the licensing authority requests, within such time period as the licensing authority may specify.

(4) The licensing authority must as soon as reasonably practicable after receipt of the information specified in sub-paragraph (3), issue a parallel import licence to the holder of the parallel distribution notice.

Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A) U.K.

29.— (1) Sub-paragraph (2) applies where—

(a) a marketing authorisation was in force before IP completion day,

(b) that authorisation is in force as a UK marketing authorisation 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 60A(2)(a) to (e) (condition as to the submitting of samples and other information to the appropriate authority).

(2) Where this sub-paragraph applies, the UK marketing authorisation is deemed to include the batch testing condition on and after IP completion day.

(3) Sub-paragraph (4) applies where a holder of a UK 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 60A(2)(a) to (e).

(4) Where this sub-paragraph applies, the holder of the UK marketing authorisation is deemed to have satisfied the batch testing condition 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) The appropriate authority—

(a) must include each EEA State on the list it publishes under regulation 60A(5) on IP completion day; and

(b) must not, before the end of the transitional period, exercise its powers under regulation 60A(8) to remove an EEA State from the list it publishes under regulation 60A(5).

(6) For the purposes of regulation 60A(9), the appropriate authority must, on IP completion day—

(a) include Switzerland and Israel in the list it publishes under that paragraph; and

(b) include in respect of those countries any conditions or restrictions in the arrangement with those countries that affect the applicability of the batch testing exemption.

(7) In this paragraph—

(a) “the transitional period” means the period of 24 months beginning with IP completion day; and

(b) “the batch testing condition” and “the batch testing exemption” have the same meaning as in regulation 60A.

(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.

Application of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B) U.K.

F2 29A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2 Sch. 33A para. 29A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 145

Existing data and marketing exclusivity and global marketing authorisations U.K.

30.— (1) Sub-paragraph (2) applies in relation to a UK marketing authorisation which, immediately before IP completion day, is part of a global marketing authorisation with one or more EU marketing authorisations or marketing authorisations granted by the competent authority of an EEA state.

(2) Where this sub-paragraph applies, the provisions of regulation 48(5) (definitions for Part 5), in so far as they describe a global marketing authorisation by reference to UK marketing authorisations only, do not affect the periods of data and marketing exclusivity to which the holder of a UK marketing authorisation to which this paragraph applies is entitled immediately before IP completion day.

Applications for EU marketing authorisations made before IP completion day U.K.

31.— (1) Sub-paragraph (2) applies where, before IP completion day—

(a) an application has been made to the EMA for an EU marketing authorisation; but

(b) no final decision has been made by the European Commission in relation to the grant of an EU marketing authorisation under Article 10 of Regulation (EC) No 726/2004.

(2) Where this sub-paragraph applies, the applicant may apply to the licensing authority for the grant of a UK marketing authorisation by submitting to the licensing authority—

(a) a copy of the application for the EU marketing authorisation; and

(b) if requested by the licensing authority, such material or information that the licensing authority reasonably considers necessary for dealing with the application.

(3) Sub-paragraph (4) applies where, before IP completion day and in relation to an application to which sub-paragraph (2) applies, a final opinion favourable to the granting of an EU marketing authorisation has been given by the Committee for Medicinal Products for Human Use and the United Kingdom concurred with that opinion.

(4) Where this sub-paragraph applies, the licensing authority must grant a UK marketing authorisation in response to an application as described in sub-paragraph (2) as soon as reasonably practicable after it is received.

(5) Sub-paragraph (6) applies where before IP completion day, in relation to an application to which sub-paragraph (2) applies—

(a) no final opinion favourable to the granting of an EU marketing authorisation has been given by the Committee for Medicinal Products for Human Use; or

(b) such an opinion has been given but the United Kingdom recorded a divergent opinion.

(6) Where this sub-paragraph applies, the licensing authority must consider an application made under sub-paragraph (2) in accordance with Part 5 of these Regulations (marketing authorisations).

Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications) U.K.

32.— (1) Subject to sub-paragraph (2), a person—

(a) who applied to the EMA for an EU marketing authorisation before IP completion day;

(b) to whom the licensing authority grants a UK marketing authorisation on or after IP completion day in response to that application in accordance with paragraph 31; and

(c) who was, immediately before IP completion day, established in an EEA State, and remains established there on and after IP completion day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 49(3), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) Sub-paragraph (1) applies to a person only if, when submitting a copy of the application for the EU marketing authorisation to the licensing authority in accordance with paragraph 31, the person notifies the licensing authority in writing of—

(a) a named individual who resides and operates in the United Kingdom whom the licensing authority may contact in respect of any matter relating to the UK marketing authorisation during the transitional period; and

(b) that individual's address, telephone number and email address.

(3) In this paragraph, “the transitional period” means the period which beginning with the date on which the licensing authority grants a UK marketing authorisation as described in paragraph 31(4) and ending 24 months after IP completion day.

Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day U.K.

33.— (1) Subject to sub-paragraph (2), a person to whom paragraph 32(1) applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc) during the transitional period to the extent that—

(a) the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet, do not include the correct information as to—

(i) the name and address of the holder of the marketing authorisation, or, where applicable, the name of the holder's representative,

(ii) the number of the marketing authorisation, or

(iii) the name and address of the manufacturer of the product; and

(b) the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i) the number of the marketing authorisation is the number of the EU marketing authorisation to which the application for the EU marketing authorisation related, or

(ii) the UK marketing authorisation holder has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 49(3), and the information specified in paragraph (a)(i) or (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a) the packaging and package leaflet met the requirements of Part 13 as to the matters specified in sub-paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b) the UK marketing authorisation holder, being aware of the number of the UK marketing authorisation and having established in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

(3) In this paragraph, “the transitional period” means the period beginning with the date on which the licensing authority grants a UK marketing authorisation as described in paragraph 31(4) and ending 36 months after IP completion day.

Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied U.K.

34.— (1) Sub-paragraph (2) applies where an application for a UK marketing authorisation has been made before IP completion day and—

(a) regulation 58(6) and (7) of the 2012 Regulations (applications to be determined under Chapter 4 of Title III of the 2001 Directive) applied to that application before IP completion day; but

(b) a decision as specified in Article 28(5) of the 2001 Directive has not been adopted by the licensing authority before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must—

(a) where the procedure specified in Article 28(4) of the 2001 Directive has concluded before IP completion day in relation to that application, grant a UK marketing authorisation in respect of that application as soon as reasonably practicable, and in any event before the end of the period of 30 days, beginning with IP completion day; or

(b) where the procedure specified in Article 28(4) of the 2001 Directive has not concluded before IP completion day, determine that application in accordance with Part 5 of these Regulations (marketing authorisations) as soon as reasonably practicable, unless the applicant notifies the licensing authority in writing that they no longer want the application to proceed.

(3) In making a determination under sub-paragraph (2)(b), the licensing authority must have regard to—

(a) any relevant information obtained by it before IP completion day in relation to the application as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a reference member state or concerned member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive; and

(c) any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) In making a determination under sub-paragraph (2)(b), the licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a UK marketing authorisation in the time period specified in regulation 58(1) (consideration of application) as if it had applied to that application on the date on which the application was submitted.

Transitional provision in respect of Plasma Master Files U.K.

35.— (1) This paragraph applies in relation to a UK marketing authorisation or EU marketing authorisation—

(a) which was granted before IP completion day;

(b) the application for which made reference to a Plasma Master File within the meaning of paragraph 1.1(a), first indent, of Part III of Annex I to the 2001 Directive which was certified by the EMA in accordance with paragraph 1.1(c) of that Part of the Annex; and

(c) which remains in force as a UK marketing authorisation on and after IP completion day.

(2) A holder of the UK marketing authorisation to which this paragraph applies may, subject to complying with the obligations in sub-paragraph (3), continue to refer to the Plasma Master File as certified by the EMA, notwithstanding the modifications to paragraph 1.1(c) of Part III of Annex I to the 2001 Directive in Schedule 8B, subject which that paragraph is to be read on and after IP completion day.

(3) The holder of a UK marketing authorisation to which this paragraph applies must notify the licensing authority of—

(a) the outcome of the annual update and recertification of the Plasma Master File by the EMA within 4 weeks beginning with the completion of that update and recertification;

(b) any application for changes to the terms of the Plasma Master File which the holder seeks from the EMA, within 4 weeks beginning with the date of the application; and

(c) the outcome of any application referred to in paragraph (b), within 4 weeks beginning with the date on which the holder is notified of that outcome.

(4) The licensing authority may at any time review the terms of a Plasma Master File to which reference is made in accordance with sub-paragraph (2), with a view to exercising its powers under these Regulations in relation to the UK marketing authorisation.

Suspensions of UK marketing authorisations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive or Regulation (EC) No 726/2004 U.K.

36.   Where, immediately before IP completion day, a marketing authorisation, which is a UK marketing authorisation on IP completion day, has been suspended pursuant to the procedures in Chapter IV of Title III of 2001 Directive or Regulation (EC) No 726/2004, the suspension—

(a) continues to have effect on and after IP completion day in accordance with the terms on which it was imposed; and

(b) is to be treated as if it had been imposed by the licensing authority under Part 5 (marketing authorisations).

Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion day U.K.

37.— (1) Sub-paragraph (2) applies where—

(a) a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day; but

(b) that procedure has not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 68 (revocation, variation and suspension of UK marketing authorisation) as soon as reasonably practicable.

(3) In making a decision under regulation 68 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a) any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive; and

(c) any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11.

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 68 in accordance with sub-paragraph (2) in a case where the Committee for Medicinal Products for Human Use or the Co-ordination Group for Mutual Recognition and Decentralised Procedures (as the case may be) has given a final opinion in relation to the matter referred under Article 31 of the 2001 Directive.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11 (advice and representations).

(6) Sub-paragraph (7) applies where—

(a) a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day;

(b) that referral has concluded before IP completion day; but

(c) the licensing authority has not, before IP completion day, taken the steps necessary to give effect to that decision or that opinion (as the case may be).

(7) Where this sub-paragraph applies, the licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the UK marketing authorisation—

(a) as soon as reasonably practicable; and

(b) in the case of a UK marketing authorisation that is not a converted EU marketing authorisation, within the period specified in Article 34(3) of the 2001 Directive (if relevant).

(8) In this paragraph—

“concluded before IP completion day”, in relation to an Article 31 referral, means—

(a)

a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; or

(b)

an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 31 referral procedure, has been given before IP completion day; and

“specified matter” means—

(a)

a matter referred under Article 31 of the 2001 Directive before IP completion day that concerns a proposal to suspend, revoke or otherwise vary a UK marketing authorisation or an EU marketing authorisation; but

(b)

does not include a referral made under Article 107i of the 2001 Directive.]