Paragraph 1 Structure of the pharmacovigilance system master fileF1

(1)

The information in the pharmacovigilance system master file must be accurate and reflect the pharmacovigilance system in place.

(2)

The holder may, where appropriate, use separate pharmacovigilance systems for different categories of medicinal products and if it does so, each such system must be described in a separate pharmacovigilance system master file.

(3)

All medicinal products for which the holder obtained a UKMA(GB) F2or a UKMA(UK)(Category 1) in accordance with these Regulations must be covered by a pharmacovigilance system master file.

Annotations

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)
F2: Words in Sch. 12A para. 1(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(a)