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Paragraph 49 Clinical trial authorisations

(1)

A fee of F1£302 is payable under regulation 20(2)(a) in connection with a F2modification request relating to a modification to the dossier, or to the protocol, related to a request for authorisation to conduct a clinical trial.

Annotations

Textual amendments

F1

Sum in Sch. 2 para. 49(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(24)

F2

Words in Sch. 2 para. 49 substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 43(3)