The Human Medicines Regulations 2012

[F1 Further obligations in respect of pharmacovigilance activities U.K.

Textual Amendments

F1 Reg. 205A and cross-heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 167 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 134); 2020 c. 1, Sch. 5 para. 1(1)

Further obligations in respect of pharmacovigilance activities U.K.

205A.— (1) Schedule 12A applies in relation to medicinal products for sale or supply under a UKMA(GB) or THR(GB) and makes further provision as to the obligations of a holder and the licensing authority in respect of the performance of pharmacovigilance activities under this Part.

(2)  The Secretary of State may by regulations in respect of Great Britain amend Schedule 12A.

(3) Regulations under paragraph (2) may make provision regarding the performance of pharmacovigilance activities under this Part as to—

(a) the content and maintenance of the pharmacovigilance system master file kept by the holder;

(b) the minimum requirements for the quality system for the performance of pharmacovigilance activities by the holder and the licensing authority;

(c) the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;

(d) the minimum requirements for the monitoring of data recorded by the licensing authority pursuant to regulation 185 (recording obligations on the licensing authority) to determine whether there are new risks or whether risks have changed;

(e) the format and content of electronic transmission of suspected adverse reactions by a holder;

(f) the format and content of electronic periodic safety reports and risk management plans; and

(g) the format of protocols, abstracts and final study reports for the post-authorisation safety studies.]