The Human Medicines Regulations 2012

Application for traditional herbal registration

Application for grant of traditional herbal registration

127.—(1) The licensing authority may, subject to regulation 130, grant an application for a traditional herbal registration for a traditional herbal medicinal product in response to an application made in accordance with this Part.

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

(3) The applicant must be established in the European Union.

(4) 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.

(5) An application is treated as signed for the purposes of paragraph (4)(b) if it is signed with an electronic signature.

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

(7) The application must include a statement indicating whether the product to which the application relates should be available—

(a) only from a pharmacy; or

(b) on general sale.

(8) The application must include a statement indicating—

(a) whether any terms of the registration are proposed relating to the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product); and

(b) if so, what terms are proposed.

Accompanying material

128.—(1) The applicant for the grant of a traditional herbal registration must provide the material specified in Schedule 12 in relation to the product.

(2) 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.

(3) If the application relates to a product that is contained in the list referred to in Article 16f(1) of the 2001 Directive—

(a) the applicant does not need to provide the material referred to in paragraphs 16 to 20 of Part 1 of Schedule 12; and

(b) paragraph (2) of this regulation does not apply.

(4) Material that is submitted under this regulation must be submitted in accordance with Annex I to the 2001 Directive, so far as applicable to traditional herbal medicinal products.

Obligation to update information supplied in connection with application

129.—(1) The applicant for a traditional herbal registration must update information supplied in connection with the application to include any further information that is relevant to the evaluation of the safety, quality or efficacy of the product concerned.

(2) Updated information within paragraph (1) must be provided as soon as is reasonably practicable after the applicant becomes aware of it.