Reference:GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B
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| Document information | |
|---|---|
| Reference | GBR The Human Medicines Regulations 2012 01-Jan-2025 |
| Validity area | GBR |
| Scope(s) | HM |
| Document name | The Human Medicines Regulations 2012 |
| Version / Revision | 01-Jan-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | The Human Medicines Regulations 2012 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.2 |
| Scope | HM |
| Document part | Article 51B |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Marketing authorisation holder, Regulatory submission, Medicinal product, MHRA |
Content
Application for UKMA(UK) relating to generic medicinal products 51B.—(1) An applicant for a UKMA(UK) for a generic medicinal product 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 if the applicant can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised for not less than eight years under regulation 49(1)(a) (subject to paragraphs (2) and (3)).
(2) In the case of an application under this regulation 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.
(3) The applicant may omit bioavailability studies from an application under this regulation if the applicant can demonstrate that the generic medicinal product meets the relevant criteria as specified in the guidelines referred to in paragraph (4).
(4) The licensing authority may publish guidelines specifying the criteria to be met by generic medicinal products for the purpose of omitting bioavailability studies from an application in accordance with paragraph (3).
(5) Until replaced by guidelines published under paragraph (4), the guidelines published by the EMA under Article 10(2)(b) of the 2001 Directive continue to apply as they applied immediately before IP completion day (subject to any amendments or variations published under paragraph (4)).
(6) If the licensing authority grants a UKMA(UK) in relation to the generic medicinal product in accordance with paragraph (1), 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 ten years beginning with the date on which the UK marketing authorisation for the reference medicinal product was granted.
(7) If during the first eight of the ten years referred to in paragraph (6) the marketing authorisation holder for the reference medicinal product obtained a UK marketing authorisation for one or more new therapeutic indications, and, during the scientific evaluation prior to their authorisation, the licensing authority considers the new indications bring a significant clinical benefit in comparison with existing therapies, the period of ten years referred to in paragraph (6) is extended to eleven years.
(8) Where an application for grant or variation of a UKMA(UK) is made in relation to a new indication for a well-established substance; and significant pre-clinical or clinical studies were carried out in relation to the new indication, the applicant for a UKMA(UK) under paragraph (1) or regulation 52B or 53B, may not refer in its application to those studies for the period of one year beginning with the date on which the licensing authority grants or varies the UKMA(UK) in relation to the new indication.
