Paragraph 24 Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion dayF1

(1)

Sub-paragraph (2) applies where—

(a)

the European Commission has requested the opinion of the EMA in accordance with Article 20(2) of Regulation (EC) No 726/2004 in relation to a specified matter; but

(b)

no final decision has been adopted by the European Commission in accordance with Article 20(3) of that Regulation immediately 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 the procedure under Article 20 of Regulation (EC) No 726/2004;

(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 the Council Decision of 28 June 1999 laying down the procedure for the exercise of implementing powers conferred on the Commission; 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 has given a final opinion in relation to the specified matter.

(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.

(6)

Sub-paragraph (7) applies where—

(a)

the European Commission has requested the opinion of the EMA in accordance with Article 20(2) of Regulation (EC) No 726/2004 in relation to a specified matter;

(b)

a final decision has been adopted by the European Commission in accordance with Article 20(3) of that Regulation immediately before IP completion day; but

(c)

the necessary steps to give effect to the decision referred to in paragraph (b) have not been taken before IP completion day.

(7)

Where this sub-paragraph applies, the licensing authority must, where a Commission decision or opinion requires steps to be taken in respect of an EU marketing authorisation that is a converted EU marketing authorisation, take the steps necessary as a result of the decision or opinion to suspend, revoke or vary a converted EU marketing authorisation as soon as reasonably practicable.

(8)

In this paragraph, “specified matter” means a matter in relation to which the opinion of the EMA has been requested by the European Commission under Article 20(2) of Regulation (EC) No 726/2004 before IP completion day that might result in the suspension, revocation or variation of an EU marketing authorisation which is a converted EU marketing authorisation.

Annotations

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)