The Human Medicines Regulations 2012

[F1 Application or notification in respect of a variations made before IP completion day under Article 20 of Regulation (EC) No 1234/2008 (work-sharing procedure) U.K.

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

(a) an application or notification in respect of a variation to a UK marketing authorisation has been submitted to the licensing authority, as a relevant authority or the reference authority, under Article 20 of Regulation (EC) No 1234/2008;

(b) the marketing authorisation is one to which Chapter II or IIa of that Regulation applied; and

(c) the procedure in Article 20(8) has not been completed before IP completion day.

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

(a) determine which of the provisions specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the steps that have already been undertaken under Article 20 of Regulation (EC) No 1234/2008 before IP completion day;

(b) assess the application or notification in accordance with the relevant provisions in that Schedule, as if the application or notification had been made under them; and

(c) take all reasonable steps to ensure that it assesses the notification or application in accordance with any relevant time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

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

(a) any opinion given by the reference authority before IP completion day in relation to that application;

(b) any relevant information obtained by it before IP completion day, as a reference authority or relevant authority, in relation to the application or notification by virtue of any procedure provided for in regulation 20 of Regulation (EC) No 1234/2008; and

(c) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a relevant authority.

(4) Paragraphs 15 and 16 of Schedule 10A apply to any variation that falls under sub-paragraph (1).]

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)