The Human Medicines Regulations 2012

[F1 Application for UKMA(UK) relating to generic medicinal products U.K.

51B.— (1) This regulation applies in relation to an application for a UKMA(UK) for a generic medicinal product.

(2) Where the application relies on a reference medicinal product which is the subject of—

(a) a UKMA(UK), the provisions of regulation 51(1) and (2) apply in respect of the application;

(b) a separate UKMA(GB) and UKMA(NI), paragraphs (3) to (5) apply.

(3) The applicant may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials only after the expiry of both—

(a) the period referenced in the applicable Article referred to in regulation 51(1), in relation to the UKMA(NI) for the reference medicinal product; and

(b) the period specified in regulation 51A(1), in relation to the UKMA(GB) for the reference medicinal product.

(4) In the case of an application under paragraph (3) in relation to a salt, ester, ether, isomer, mixture of isomers, complex or derivative of an authorised active substance which differs significantly in properties with regard to safety or efficacy from the active substance in the reference medicinal product, the applicant must supply additional information providing proof of the safety or efficacy of the salt, ester, ether, isomer, mixture of isomers, complex or derivative.

(5) If the licensing authority grants a UK marketing authorisation in relation to the generic medicinal product in accordance with paragraph (3), it is a term of the authorisation that the product must not be sold or supplied, or offered for sale or supply, in the United Kingdom before the expiry of both—

(a) the period specified in regulation 51(2), in relation to the UKMA(NI) for the reference medicinal product; and

(b) the period specified in regulation 51A(6) or (where applicable) 51A(10), in relation to the UKMA(GB) for the reference medicinal product.

(6) Paragraph (7) applies where—

(a) an application for the grant or variation of a UKMA(UK) is made in relation to a new indication for a well-established substance; and

(b) significant pre-clinical or clinical studies were carried out in relation to the new indication.

(7) Where this paragraph applies, the applicant for a UKMA(UK) under paragraph (1) or regulation 52B or 53B may not refer in its application to the studies mentioned in paragraph (6)(b) for the period of one year beginning on the date on which the licensing authority grants or varies a UKMA(UK) in relation to the new indication.]

Textual Amendments

F1 Regs. 51-51B substituted for reg. 51 (31.12.2020) by S.I. 2019/775, regs. 1, 56 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 41)