The Human Medicines Regulations 2012 No. 1916

SCHEDULES

[F1 SCHEDULE 33A U.K. Transitional provision in relation to EU Exit

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)

PART 3 U.K. Transitional provision in respect of conversion of EU marketing authorisations in force immediately before IP completion day

Applications for renewals of converted EU marketing authorisations made after IP completion day U.K.

16.— (1) This paragraph applies where a holder of a converted EU marketing authorisation is due to make an application for renewal of the authorisation in accordance with regulation 66 (application for renewal of authorisation) during the period of one year beginning with IP completion day.

(2) Where this paragraph applies—

(a) the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the baseline data so that it is received by the licensing authority at the same time as the application for renewal is made;

(b) the licensing authority must consider the renewal application in accordance with regulation 66; and

(c) the converted EU marketing authorisation remains in force until the licensing authority notifies the holder of its decision on the renewal application.]