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 4 U.K. Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority

Audit U.K.

17.— (1) Risk-based audits of the quality system must be performed by the licensing authority at regular intervals to ensure that the quality system complies with the requirements set out in paragraphs 8, 14, 15 and 16, and to ensure its effectiveness.

(2) Following a risk-based audit—

(a) any corrective action, including a follow-up audit of deficiencies, must be taken where necessary;

(b) a report on the results of the audit must be drawn up for each audit and follow-up audit;

(c) the audit report must be sent to the management responsible for the matters audited; and

(d) the dates and results of audits and follow-up audits must be documented.]