Paragraph 2 Licensing authority decisionF1

(1)

In the case of a decision not to accept a request for authorisation to conduct a clinical trial or F2a substantial modification, the licensing authority shall, after considering the report of the appropriate committee—

(a)

confirm that they have grounds for not accepting the request or F3modification; or

(b)

accept the request for authorisation or F4modification, subject to such conditions as the licensing authority may consider appropriate.

(2)

In the case of a decision to impose a condition following a request for authorisation to conduct a clinical trial or a F5valid modification request, the licensing authority shall, after considering the report of the appropriate committee—

(a)

confirm their decision; or

(b)

remove or alter the condition in question.

(3)

In the case of a notice to suspend or terminate a trial, the licensing authority shall, after considering the report of the appropriate committee, confirm or revoke the notice.

(4)

The licensing authority shall give notice to the sponsor or investigator of—

(a)

the findings and advice of the appropriate committee and the reasons for it;

(b)

their decision in accordance with sub-paragraph (1), (2) or (3).

Annotations

Textual amendments

F1: Sch. 5 substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 3 para. 5
F2: Words in Sch. 5 para. 2(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 41(3)(a)(i)
F3: Word in Sch. 5 para. 2(1)(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 41(3)(a)(ii)
F4: Word in Sch. 5 para. 2(1)(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 41(3)(a)(iii)
F5: Words in Sch. 5 para. 2(2) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 41(3)(b)