The Human Medicines Regulations 2012

[F1 Application for UKMA(NI) relating to generic medicinal products U.K.

51.— (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.]

Textual Amendments

F1 Regs. 51-51B substituted for reg. 51 (31.12.2020) by S.I. 2019/775, regs. 1, 56 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 41)