The Human Medicines Regulations 2012

Application for certificate of registration U.K.

103.—(1) The licensing authority may, subject to regulation 104, grant an application for a certificate of registration for a registrable homoeopathic medicinal product in response to an application made in accordance with this Part.

[F1 (1A) The licensing authority may accept an application meeting reduced or alternative requirements specified in this Part (“under the unfettered access route”) and grant a COR(GB) only where—

(a) there is already in place, or will be at the time the COR(GB) is granted, a certificate of registration in respect of the product authorising sale or supply in Northern Ireland,

(b) the applicant complies with the requirements in paragraph (5B), and

(c) the registrable homoeopathic medicinal product satisfies the definition of qualifying Northern Ireland goods.

(1B) A certificate of registration must state whether it is in force in—

(a) the whole United Kingdom;

(b) Great Britain only; or

(c) Northern Ireland only,

and in these Regulations the meaning of a reference to that certificate of registration being “in force” is limited to that territory.]

(2) A certificate granted under paragraph (1) shall contain terms approved by the licensing authority.

(3) The application may relate to two or more homoeopathic medicinal products derived from the same homoeopathic stock or the same combination of homoeopathic stocks.

(4) The applicant [F2 where it is applying for—

(a) a COR(NI)—

(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)—

(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) a COR(UK), must be established in the United Kingdom.]

(5) 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.

[F3 (5A) The application must include a statement indicating whether the certificate sought is for sale or supply of the product in—

(a) the whole United Kingdom;

(b) Great Britain only; or

(c) Northern Ireland only.

(5B) The applicant for the grant of a COR(GB) under the unfettered access route must provide—

(a) the application form submitted in connection with the granting of the COR(NI) which authorises the sale or supply of the product in Northern Ireland;

(b) a copy of all material submitted in support of the application for the COR(NI) which authorises the sale or supply of the product in Northern Ireland; and

(c) a copy of the COR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland,

together with any material specified in paragraph (8) which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.]

(6) An application is treated as signed for the purposes of paragraph (5)(b) if it is signed with an electronic signature.

(7) The application and any accompanying material must be in English.

(8) The applicant must provide each of the following for each product to which the application relates—

(a) a statement of the scientific name, or other name given in a pharmacopoeia, of the homoeopathic stock or stocks from which the product is derived;

(b) a statement of the routes of administration, pharmaceutical forms and degree of dilution of the product;

(c) a dossier describing how the homoeopathic stock or stocks are obtained and controlled and justifying their homoeopathic use on the basis of an adequate bibliography;

(d) a manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation of the product;

(e) evidence that each manufacturer of the medicinal product is authorised to manufacture it (which, in the case of a product manufactured in the United Kingdom F4 ..., means the manufacturer's licence or (as the case may be) its equivalent in [F5 a country other than the United Kingdom]);

(f) where an authorisation to place the product on the market has been granted by [F6 a country other than the United Kingdom], a copy of the authorisation;

(g) a mock-up of the outer and immediate packaging of the product; and

(h) data concerning the stability of the product.

(9) This material, taken as a whole, must be such as to demonstrate the pharmaceutical quality and batch to batch homogeneity of each product to which the application relates.

(10) The applicant must also, if requested by the licensing authority to do so, provide the licensing authority with material or information that the licensing authority reasonably considers necessary for considering the application.

Textual Amendments

F1 Reg. 103(1A)(1B) inserted (31.12.2020) by S.I. 2019/775, reg. 99(1A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 76(a))

F2 Reg. 103(4)(a)-(c) substituted for words in reg. 103(4) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 99(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 76(b)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Reg. 103(5A)(5B) inserted (31.12.2020) by S.I. 2019/775, reg. 99(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 76(c))

F4 Words in reg. 103(8)(e) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 99(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 103(8)(e) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 99(3)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 103(8)(f) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 99(3)(b); 2020 c. 1, Sch. 5 para. 1(1)