Regulation 18A Request for further information regarding a request for approvalF1

(1)

A notice given in accordance with regulation 18(3)(b)(iii) must—

(a)

request further information required to reconsider the approval of the request; and

(b)

specify whether the request for further information relates to either or both of the following—

(i)

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

(ii)

the ethics committee opinion.

(2)

If the sponsor is given a notice which contains a request for further information in accordance with paragraph (1), the sponsor may send an amended request for approval for further consideration within—

(a)

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

(b)

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

(3)

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

(4)

In this regulation, “appropriate authority” has the meaning given in regulation 18B(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