Regulation 184 Obligation on holder to audit pharmacovigilance system

(1)

The holder must—

(a)

perform a regular audit of its pharmacovigilance system;

(b)

place a note concerning the main findings of each audit on the pharmacovigilance system master file on completion of each audit; and

(c)

ensure that an appropriate corrective action plan is prepared and implemented as soon as is reasonably practicable after completion of each audit.

(2)

The holder may remove the note placed on the pharmacovigilance system master file under paragraph (1)(b) when all the measures in the corrective action plan under paragraph (1)(c) have been fully implemented.

F1(3)

The holder of a UKMA(GB) F2, UKMA(UK)(Category 1) or THR(GB) must also comply with the requirements of paragraph 13 of Schedule 12A in relation to auditing the pharmacovigilance system.

Annotations

Textual amendments

F1: Reg. 184(3) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 143 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 112); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 184(3) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 77