108.—(1) An application for the renewal of a certificate of registration must be made to the licensing authority.
(2) The applicant [F1, where it is applying for renewal of—
(a)a COR(NI) and originally granted—
(i)in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;
(ii)on any other basis, must be established in the United Kingdom;
(b)a COR(GB) and originally granted—
(i)under the unfettered access route, must be established in Northern Ireland;
(ii)other than under the unfettered access route, must be established in the United Kingdom;
(c)in the whole United Kingdom, must be established in the United Kingdom.]
(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 107 (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 all amendments made since the authorisation was granted).
(7) The licensing authority may renew a certificate only if, having considered the application and the material accompanying it, the authority thinks that the risks to the health of patients or of the public associated with the homoeopathic medicinal product to which the certificate relates do not outweigh any beneficial effects of the product.
(8) Schedule 11 makes provision about advice and representations in relation to an application for the renewal of a certificate of registration.
Textual Amendments
F1Reg. 108(2)(a)-(c) substituted for words in reg. 108(2) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 101 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 78); 2020 c. 1, Sch. 5 para. 1(1)