Regulation 20 Fees for modifications to clinical trial authorisationsF3

(1)

A person who sends a F1modification request under regulation 22 (modifications by the sponsor) of the Clinical Trials Regulations relating to amendment of the protocol or the dossier related to a request for authorisation in accordance with F2paragraphs 2 or 5(a) of Part A1 of Schedule 3 (request for approval) to those Regulations must pay the fees mentioned in paragraph (2).

(2)

The fees referred to in paragraph (1) are—

(a)

the fee prescribed in paragraph 49 of Schedule 2 in connection with that amendment; and

(b)

in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 30, 32, 33, 35 and 37.

Annotations

Textual amendments

F1: Words in reg. 20(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 43(2)(b)(i)
F2: Words in reg. 20(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 43(2)(b)(ii)
F3: Word in reg. 20 heading substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 43(2)(a)