Substitution of regulation 52 (applications relating to certain medicinal products that do not qualify as generic etc)57

For regulation 52 substitute—

Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc52

1

This regulation applies where—

a

an application is made for a UKMA(NI) by reference to another medicinal product as reference medicinal product; and

b

one or more of the circumstances listed in Article 10(3) of the 2001 Directive applies in respect of the application.

2

The applicant must provide information in accordance with Article 10(3) and (6) of the 2001 Directive.

3

Paragraphs (2) to (4) of regulation 51 apply to the application as they apply in relation to an application made in accordance with paragraph (1) of that regulation.

Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc52A

1

This regulation applies where—

a

an application is made for a UKMA(GB) in respect of a product by reference to another medicinal product as reference medicinal product which is or has been authorised for sale or supply in Great Britain for not less than eight years—

i

under regulation 49(1)(a); or

ii

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

b

one or more of the following circumstances applies in respect of the application—

i

the medicinal product to which the application relates does not fall within the definition of generic medicinal product,

ii

bioequivalence with the reference medicinal product cannot be demonstrated through bioavailability studies, or

iii

the medicinal product to which the application relates differs from the reference medicinal product in terms of changes in the active substance, therapeutic indications, strength, pharmaceutical form or route of administration.

2

The applicant—

a

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 relating to the reference medicinal product; but

b

must provide the results of the appropriate pre-clinical tests or clinical trials relating to the applicable circumstance in paragraph (1)(b).

3

Paragraphs (2) to (10) of regulation 51A apply to the application as they apply in relation to an application made in accordance with paragraph (1) of that regulation.

Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc52B

1

This regulation applies in relation to an application for a UKMA(UK) in respect of a product by reference to another medicinal product as reference 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 52(1) and (2) apply in respect of the application;

b

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

3

Subject to paragraph (4), 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 regulation 52(1), in relation to the UKMA(NI) for the reference medicinal product; and

b

the period specified in regulation 52A(1), in relation to the UKMA(GB) for the reference medicinal product.

4

Where one or more of the following circumstances applies in respect of the application—

a

the medicinal product to which the application relates does not fall within the definition of generic medicinal product,

b

bioequivalence with the reference medicinal product cannot be demonstrated through bioavailability studies, or

c

the medicinal product to which the application relates differs from the reference medicinal product in terms of changes in the active substance, therapeutic indications, strength, pharmaceutical form or route of administration,

the applicant must provide the results of the appropriate pre-clinical tests or clinical trials relating to the applicable circumstance.

5

Paragraphs (4) and (5) of regulation 51B apply to the application as they apply in relation to an application made in accordance with paragraph (3) of that regulation.