The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

35.  In regulation 47 (amendment of regulation 48 (application of Part 5))—

(a) in paragraph (2)(a)—

(i) for the definition of “EU reference medicinal product”, substitute—

““EU reference medicinal product” means a medicinal product which falls within paragraph (b)(ii) or (iii) of the definition of “reference medicinal product”;”;

(ii) after the definition of “EU reference medicinal product”, insert—

““excluded reference product” means—

(a)

a medicinal product authorised on the basis that it was a generic medicinal product;

(b)

a medicinal product authorised on the basis that one or more of the circumstances listed in Article 10(3) of the 2001 Directive or regulation 52(1)(b) applied; or

(c)

a biological medicinal product authorised on the basis that it did not meet a condition for being a generic medicinal product for any of the reasons described in Article 10(4) of the 2001 Directive or regulation 53A(1);”;

(b) in paragraph (2)(b), for the definition of “generic medicinal product”, substitute—

““generic medicinal product”, in relation to a reference medicinal product for an application for—

(a)

a UKMA(NI) or UKMA(UK), has the meaning given in Article 10(2)(b) of the 2001 Directive;

(b)

a UKMA(GB), means a medicinal product—

(i)

that has the same qualitative and quantitative composition in active substances as the reference medicinal product;

(ii)

that has the same pharmaceutical form as the reference medicinal product; and

(iii)

whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies;”;

(c) in paragraph (2)(d), for the definition of “reference medicinal product” substitute—

““reference medicinal product” means—

(a)

in relation to an application for a UKMA(NI), a medicinal product—

(i)

authorised for sale or supply in Northern Ireland under regulation 49(1)(a), in accordance with the provisions of regulation 50; or

(ii)

in relation to which an EU marketing authorisation or a marketing authorisation granted by a member State pursuant to the 2001 Directive is or has been in force,

but which is not an excluded reference product;

(b)

in relation to an application for a UKMA(GB), a medicinal product—

(i)

authorised under regulation 49(1)(a), in accordance with the provisions of regulation 50;

(ii)

in relation to which an EU marketing authorisation was in force on IP completion day, but in relation to which no UK marketing authorisation is in force because the holder of the EU marketing authorisation notified the licensing authority in accordance with paragraph 6(3) of Schedule 33A that it did not wish to be the holder of a converted EU marketing authorisation; or

(iii)

in relation to which an EU marketing authorisation had ceased to be in force before IP completion day for reasons not related to safety, quality or efficacy,

but which is not an excluded reference product;

(c)

in relation to an application for a UKMA(UK), a medicinal product—

(i)

authorised under regulation 49(1)(a) for sale or supply in the whole of the United Kingdom, whether by virtue of one or more UK marketing authorisations, in accordance with the provisions of regulation 50; or

(ii)

in relation to which an EU marketing authorisation or a marketing authorisation granted by a member State pursuant to the 2001 Directive is or has been in force,

but which is not an excluded reference product;”;

(d) in paragraph (3)—

(i) in the inserted paragraph (6)(b), for “regulations 51 to 53” substitute “regulations 51 to 53B”;

(ii) in the inserted paragraph (7), for “regulation 51(1) and (8)” substitute “regulation 51A(1) and (6)”;

(iii) in the inserted paragraph (8)(b), for “regulations 51 to 53” substitute “regulations 51 to 53B”;

(iv) in the inserted paragraph (9), for “regulation 51(1) and (8)” substitute “regulation 51A(1) and (6)”.