Regulation 39 Substitution of regulation 52BI1

For regulation 52B (application for UKMA(UK)^f1 relating to certain medicinal products that do not qualify as generic etc.), substitute—

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

52B.

(1)

This Regulation applies where an application is made for a UKMA(UK) by reference to another medicinal product as reference medicinal product which is, or has been, authorised for not less than eight years under regulation 49(1)(a) and 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.

(2)

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 relating to the reference medicinal product, but must provide the results of the appropriate pre-clinical tests or clinical trials relating to the applicable circumstances in paragraph (1).

(3)

Paragraphs (2), (6) and (7) of regulation 51B apply to the application as they apply to an application made in accordance with paragraph (1) of that regulation.”.