Regulation 19E Fee for assessment of periodic safety update reportsF1

(1)

This regulation applies where—

(a)

a periodic safety update report has been submitted to the licensing authority under regulation 191 or 192 of the Human Medicines Regulations; and

(b)

that periodic safety update report relates to a medicinal product which has a UK reference date within the meaning of regulation 193 of the Human Medicines Regulations.

(2)

Where this regulation applies, the fee payable by the holder of a marketing authorisation or traditional herbal registration to which the periodic safety update report relates is—

(a)

F2£1,066, in the case where no other periodic safety update reports relating to medicinal products with the same UK reference date are submitted; and

(b)

F3£534, in any other case.

Annotations

Textual amendments

F1: Regs. 19A-19G inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 2 (with Sch. 1 para. 11) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 188(c)(i)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)
F2: Sum in reg. 19E(2)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 18(a)
F3: Sum in reg. 19E(2)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 18(b)