Application for renewal of authorisation
66.—(1) The licensing authority may renew a UK marketing authorisation in response to an application made in accordance with this regulation.
(2) The applicant must be established in the European Union.
(3) The application must be—
(a)made in writing;
(b)signed by or on behalf of the applicant; and
(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.
(4) An application is treated as signed for the purposes of paragraph (3)(b) if it is signed with an electronic signature.
(5) The application must be made so that it is received by the licensing authority before the beginning of the period of nine months ending with the expiry of the period mentioned in paragraph (1)(a) or (as the case may be) (3)(a) of regulation 65 (initial and further period of validity).
(6) The holder must provide a consolidated version of the file in respect of quality, safety and efficacy, including—
(a)the evaluation of data contained in suspected adverse reaction reports and periodic safety update reports submitted in accordance with Part 11; and
(b)all amendments made since the authorisation was granted.
(7) The licensing authority may renew a UK marketing authorisation only if, having considered the application and the material accompanying it, the authority thinks that the positive therapeutic effects of the product to which the authorisation relates outweigh the risks of the product to the health of patients or of the public.
(8) Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a UK marketing authorisation.