The Human Medicines Regulations 2012

[F1 Application or notification made before IP completion day in respect of a variation under Chapter II of Regulation (EC) No 1234/2008 (variations to marketing authorisations granted in accordance with Chapter 4 of the 2001 Directive) U.K.

39.— (1) This paragraph applies where an application or notification in respect of a variation to a marketing authorisation has been submitted to the licensing authority, as a relevant authority, under Chapter II of Regulation (EC) No 1234/2008 before IP completion day.

(2) If the procedures specified in Article 11(1) of Regulation (EC) No 1234/2008 have not concluded before IP completion day, the licensing authority must—

(a) assess the application or notification in accordance with regulation 65C and Schedule 10A to these Regulations, as if the application or notification had been made under those provisions; and

(b) make such an assessment having regard to the matters specified in sub-paragraph (5).

(3) If the procedures specified in Article 11(1) of Regulation (EC) No 1234/2008 have concluded before IP completion day—

(a) the licensing authority must take the steps specified in Article 11(2) of Regulation (EC) No 1234/2008 within the time limit specified in Article 23(1) of that Regulation; and

(b) paragraphs 15 and 16 of Schedule 10A apply to the variation.

(4) In making a determination under sub-paragraph (2), the licensing authority must—

(a) determine which steps of the procedures 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 matters specified in sub-paragraph (5); and

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

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

(a) any recommendation in relation to that application or notification given before IP completion day pursuant to Article 5 of Regulation (EC) No 1234/2008;

(b) any relevant information obtained by it before IP completion day, as a relevant authority, in relation to the application or notification by virtue of any procedure provided for in Chapter II of that Regulation; and

(c) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a relevant authority, including any matter referred under the procedure specified in Article 13 of that Regulation.]

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)