Regulation 18B Approval procedure for amended requests for approvalF1

(1)

An amended request for approval must be reviewed by the appropriate authority, which, for the purposes of this regulation, is either or both of the following—

(a)

the licensing authority, if the request for further information relates to the licensing authority’s decision on the clinical trial authorisation;

(b)

the ethics committee, if the request for further information relates to the ethics committee opinion.

(2)

The appropriate authority must notify the sponsor of its decision or its opinion, or both its decision and opinion.

(3)

A notice under paragraph (2) must—

(a)

be in writing; and

(b)

state that the appropriate authority—

(i)

approves the amended request,

(ii)

approves the amended request, subject to conditions specified in the notice, or

(iii)

does not approve the amended request, setting out the grounds for this decision.

(4)

Subject to paragraphs (6) and (7) and regulation 18C, the appropriate authority must take all reasonable steps to ensure that the notice is given within the period of 10 days beginning with the date of receipt of an amended request for approval.

(5)

If a notice is given in accordance with paragraph (3)(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 clinical trial is to be treated as approved only if the conditions specified in the notice are satisfied.

(6)

The period of 10 days referred to in paragraph (4) is extended by a further—

(a)

30 days, where the licensing authority or the ethics committee consults either or both of the following—

(i)

a relevant committee;

(ii)

a specialist group or committee;

(b)

60 days, where—

(i)

the investigational medicinal product is an advanced therapy medicinal product, and

(ii)

the licensing authority or the ethics committee consults either or both of the groups or committees mentioned in sub-paragraph (a).

(7)

If the clinical trial involves a medicinal product for xenogenic cell therapy, the time periods set out in paragraphs (4) and (6) do not apply and the appropriate authority may give written notice under this regulation at any time after receipt of an amended request for approval.

(8)

The request for approval is to be treated as rejected and the authorities may not consider any further amendments to the request if—

(a)

the authorities give written notice to the sponsor which contains a request for further information in accordance with regulation 18A(1) and the sponsor does not submit an amended request in accordance with regulation 18A(2); or

(b)

the sponsor has submitted an amended request in accordance with regulation 18A(2), but the appropriate authority gives written notice to the sponsor in accordance with paragraph (3)(b)(iii).

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