Regulation 56 Substitution of regulation 51 (applications relating to generic medicinal products)

For regulation 51 substitute—

“(1)

An applicant for a UK marketing authorisation 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—

(a)

under regulation 49(1)(a) (subject to paragraphs (2) and (3)); or

(b)

if the product is an EU reference medicinal product, under Regulation (EC) No 726/2004.

(2)

If, after exit day but before the date of grant of the UK marketing authorisation in relation to the reference medicinal product, an EU marketing authorisation took effect in relation to that product, the period of not less than eight years referred to in paragraph (1) is treated as having started on the date on which the EU marketing authorisation took effect.

(3)

If, after exit day but before the date of grant of the UK marketing authorisation in relation to the reference medicinal product, the competent authority of an EEA state granted a marketing authorisation in relation to that product, the period of not less than eight years referred to in paragraph (1) is treated as having started on the date on which the marketing authorisation in the first EEA state in which the product was authorised took effect.

(4)

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.

(5)

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 (6).

(6)

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 (5).

(7)

Until replaced by guidelines published under paragraph (6), the guidelines published by the EMA under Article 10(2)(b) of the 2001 Directive^f1 continue to apply on and after exit day as they applied immediately before exit day (subject to any amendments or variations published under paragraph (6)).

(8)

If the licensing authority grants a UK marketing authorisation 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—

(a)

the date on which the reference medicinal product was granted a UK marketing authorisation;

(b)

the date referred to in paragraph (2) or (3), if earlier than the date in sub-paragraph (a); or

(c)

if the reference medicinal product is an EU reference medicinal product, the date on which the EU marketing authorisation for the reference medicinal product took effect.

(9)

Paragraph (10) applies where an EU reference medicinal product is used as a reference medicinal product for the purposes of this regulation.

(10)

Where this paragraph applies, the terms of the marketing authorisation of the EU reference medicinal product are treated as being the terms of the product’s EU marketing authorisation as they stood immediately before exit day.

(11)

Paragraph (12) applies if—

(a)

during the first eight of the ten years referred to in paragraph (8) the marketing authorisation holder for the reference medicinal product obtained a UK marketing authorisation for one or more new therapeutic indications; and

(b)

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.

(12)

Where this paragraph applies, the period of ten years referred to in paragraph (8) is extended to eleven years, subject to the provisions of paragraphs (13) and (14).

(13)

Where the European Commission, or an EEA state, has granted or varied a marketing authorisation in relation to the new therapeutic indication before the licensing authority does so, the one year extension of the period of ten years referred to in paragraph (8) is reduced by the period of time—

(a)

beginning on the date on which the EU or EEA state marketing authorisation took effect or was varied; and

(b)

ending immediately before the date on which the licensing authority granted or varied the UK marketing authorisation.

(14)

If the period of time by which the one year extension is to be reduced in accordance with paragraph (13) is one year or longer, paragraph (12) does not apply.

(15)

Paragraph (16) applies where—

(a)

an application 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.

(16)

Where this paragraph applies, the applicant for a UK marketing authorisation under paragraph (1) or regulation 52 or 53 may not refer in its application to the studies mentioned in paragraph (15)(b) for the period of one year beginning on the date on which the licensing authority grants or varies a UK marketing authorisation in relation to the new indication (subject to paragraphs (17) and (18)).

(17)

Where the European Commission, or an EEA state, has granted or varied a marketing authorisation in relation to the new indication before the licensing authority does so, the period of one year referred to in paragraph (10) is reduced by the period of time—

(a)

beginning on the date on which the EU or EEA state marketing authorisation took effect or was varied; and

(b)

ending immediately before the date on which the licensing authority granted or varied the UK marketing authorisation.

(18)

If the period of time by which the one year period in paragraph (16) is to be reduced in accordance with paragraph (17) is one year or longer, paragraph (16) does not apply.”.