Regulation 16 Request for approval and combined procedureF1

Subject to paragraph (5), the request for authorisation under regulation 14 and the application for an ethics committee opinion under regulation 15 must be made by way of a single application dossier (a “request for approval”).

The request for approval must—

Paragraph (2)(c)(ii) does not apply where arrangements have been made with the licensing authority or the ethics committee for payment of the fee referred to in that paragraph other than at the time of the request.

The request for approval and accompanying material must be supplied in English.

In exceptional circumstances (for example, in an urgent situation where it would be beneficial to progress one request or application while preparing the other), and if agreed in advance by the licensing authority or the ethics committee, a request for authorisation under regulation 14 and an application for an ethics committee opinion under regulation 15 may be made separately.

Where an agreement has been reached under paragraph (5), the licensing authority or the ethics committee (as the case may be) must confirm—

Where an agreement has been reached under paragraph (5), the submission of both the request for authorisation and the application of an ethics committee constitutes a “request for approval”.

The authorities must confirm whether the request for approval is valid within the period of 7 days beginning with the date of the submission of the request and notify the sponsor accordingly.