Regulation 22B Request for further information regarding proposed substantial modificationsF1

(1)

A notice given in accordance with regulation 22A(4)(b)(iii) may request further information required to reconsider the approval of the request.

(2)

If the notice contains a request for further information in accordance with paragraph (1), then the notice must specify whether the request for further information relates to either or both of the following—

(a)

the licensing authority’s decision;

(b)

the ethics committee opinion.

(3)

If the sponsor is given a notice in accordance with regulation 22A(4)(b)(iii) which contains a request for further information in accordance with paragraph (1), the sponsor may send an amended modification request for further consideration within—

(a)

the period of 60 days beginning with the day on which the notice is given; or

(b)

such extended period as the appropriate authority may in any particular case allow.

(4)

An amended modification request can be a response to the request for further information or an amendment to the modification request.

(5)

In this regulation, “appropriate authority” has the meaning given in regulation 22C(1).

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