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

Record management and data retention U.K.

16.— (1) The licensing authority must—

(a) record all pharmacovigilance information, and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information; and

(b) put in place a record management system for all documents used for pharmacovigilance activities that ensures—

(i) the retrievability of those documents, and

(ii) the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.

(2) The licensing authority must arrange for the essential documents describing their pharmacovigilance system to be kept for at least five years, such period beginning with the day after the system has been formally terminated.

(3) Pharmacovigilance data and documents relating to individual authorised medicinal products must be retained by the licensing authority for as long as the product is authorised and for at least 10 years, such period beginning with the day after the UKMA(GB) [F2 or the UKMA(UK)(Category 1), as the case may be,] has expired.]

Textual Amendments

F2 Words in Sch. 12A para. 16(3) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 140(c) (with reg. 1(2))