The Human Medicines Regulations 2012 No. 1916

SCHEDULES

[F1 SCHEDULE 12A U.K. Further provision as to the performance of pharmacovigilance activities

Textual Amendments

F1 Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)

PART 7 U.K. Risk management plans

Updates of the risk management plan U.K.

24.— (1) Subject to sub-paragraph (2), where the holder updates a risk management plan, it must submit the updated risk management plan to the licensing authority.

(2) If the licensing authority agrees, the holder may submit only the modules concerned by the update.

(3) If necessary, the holder must provide the licensing authority with an updated summary of the risk management plan.

(4) Each submission of the risk management plan must—

(a) have a distinct version number; and

(b) be dated.]