Paragraph 2

Where a direction is given in accordance with paragraph 1(1)(a)—

(a)

the F1Authority shall—

(i)

send the application for that opinion, and

(ii)

any additional information provided by the F2sponsor,

to the ethics committee specified in the direction; F3...

(b)

that committee shall consider the application in accordance with F4regulation 17; and

F5(c)

that committee shall within 30 days beginning with the day on which the application is sent to the committee under paragraph (a), or such extended period as the Authority may in any particular case allow, either confirm the opinion or give a favourable opinion.

Annotations

Textual amendments

F1: Word in Sch. 4 para. 2(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(3)(a)(i)
F2: Word in Sch. 4 para. 2(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(3)(a)(ii)
F3: Word in Sch. 4 para. 2(a) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(3)(a)(iii)
F4: Words in Sch. 4 para. 2(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(3)(b)
F5: Sch. 4 para. 2(c) inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 40(3)(c)