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Paragraph 34 Clinical trial authorisations

The fee payable under regulation 12(1)(a) in connection with an application for a clinical trial authorisation is—

(a)

F1£4,656, where the application is for a product that is not marketed; or

(b)

F2£343, where the application is for a product that is marketed.

Annotations

Textual amendments

F1

Sum in Sch. 2 para. 34(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(11)(a)

F2

Sum in Sch. 2 para. 34(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(11)(b)