Regulation 22A Approval procedure for substantial modificationsF1

(1)

Where the licensing authority and an ethics committee receive a valid modification request in relation to a substantial modification to a clinical trial approval—

(a)

the licensing authority must—

(i)

review the request in relation to the authorisation to conduct the clinical trial, and

(ii)

provide its decision in accordance with this regulation;

(b)

the ethics committee must—

(i)

review the request in relation to the ethics committee opinion for the clinical trial, and

(ii)

provide an opinion in accordance with this regulation.

(2)

Where the modification request contains a statement under regulation 22(6)(c) confirming that the modification is a Route B substantial modification, the licensing authority may, if it considers appropriate and without undertaking further assessment, rely on that statement to provide its decision on the modification request.

(3)

The authorities must notify the sponsor of the decision in paragraph (1)(a)(ii) or the opinion in paragraph (1)(b)(ii), or both the decision and the opinion.

(4)

A notice under paragraph (3) must—

(a)

be in writing; and

(b)

state that the authorities—

(i)

approve the proposed modification,

(ii)

approve the proposed modification, subject to conditions specified in the notice, or

(iii)

do not approve the proposed modification, setting out the grounds for this decision.

(5)

The authorities must take all reasonable steps to ensure that the notice is given within the period of 35 days beginning with the date on which the authorities notified the sponsor that the modification request was valid in accordance with regulation 22(8).

(6)

If a notice is given in accordance with paragraph (4)(b)(ii)—

(a)

the notice must specify whether the conditions relate to either or both of the following—

(i)

the licensing authority’s decision on the clinical trial authorisation;

(ii)

the ethics committee opinion;

(b)

the modification is to be treated as approved only if the conditions specified in the notice are satisfied.

(7)

If a notice is given in accordance with paragraph (4)(b)(iii), regulations 22B and 22C apply.

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