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Regulation 20 Modifications to clinical trial approvalF1

A modification to a clinical trial approval may be made—

(a)

by the licensing authority or the ethics committee, in accordance with regulation 21; or

(b)

by the sponsor, in accordance with regulations 22, 22A and 22B.

Annotations

Textual amendments

F1

Regs. 14-26 substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 14