Application for UKMA(NI) relating to generic medicinal products51

1

An applicant for a UKMA(NI) for a relevant medicinal product that is a generic medicinal product may provide information in relation to the application in accordance with Article 10(1), (5) and (6) of the 2001 Directive.

2

If the licensing authority grants a UKMA(NI) for 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 Northern Ireland before the time at which it may be placed on the market in accordance with Article 10(1) of the 2001 Directive as modified by paragraph (3).

3

The second subparagraph of Article 10(1) of the 2001 Directive has effect with the exception described in paragraph (4).

4

Where—

a

ten years have elapsed since a UK marketing authorisation was granted otherwise than under Chapter 4 of Title III to the 2001 Directive in relation to the reference medicinal product;

b

in relation to that product there is—

i

an EU marketing authorisation, or

ii

a UKMA(NI) which was granted under that Chapter; and

c

a period of ten years has not elapsed since the authorisation mentioned in sub-paragraph (b) for sale or supply of that product in the European Union,

the product may not be made available for sale or supply in Northern Ireland until the period mentioned in sub-paragraph (c) has elapsed.

Application for UKMA(GB) relating to generic medicinal products51A

1

An applicant for a UKMA(GB) 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 authorised for sale or supply in Great Britain which is or has been authorised for not less than eight years—

a

under regulation 49(1)(a); or

b

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

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 on and after IP completion day 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(GB) 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 Great Britain before the expiry of ten years beginning with the date on which the marketing authorisation for the reference medicinal product entered into force.

7

Paragraph (8) applies where an EU reference medicinal product which falls within paragraph (b)(ii) of the definition of “reference medicinal product” is used as a reference medicinal product for the purposes of this regulation.

8

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 IP completion day.

9

Paragraph (10) applies if—

a

during the first eight of the ten years referred to in paragraph (6) the marketing authorisation holder for the reference medicinal product obtained a UKMA(GB) or a UKMA(UK) 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.

10

Where this paragraph applies, the period of ten years referred to in paragraph (6) is extended to eleven years.

11

Paragraph (12) applies where—

a

an application for the grant or variation of a UKMA(GB) 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.

12

Where this paragraph applies, the applicant for a UKMA(GB) under paragraph (1) or regulation 52A or 53A may not refer in its application to the studies mentioned in paragraph (11)(b) for the period of one year beginning on the date on which the licensing authority grants or varies a UKMA(GB) in relation to the new indication.

Application for UKMA(UK) relating to generic medicinal products51B

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.