The Human Medicines Regulations 2012

Application of this Part U.K.

48.—(1) This Part applies to relevant medicinal products.

(2) In this Part—

[F1 “EU reference medicinal product” means a medicinal product which falls within paragraph (b)(ii) or (iii) of the definition of “reference medicinal product;]

[F1 “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);]

[F2 “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;]

[F3 “parallel import licence” means a licence that is granted by the licensing authority under this Part authorising the holder to place on the market a medicinal product imported in to the United Kingdom from an EEA State where that product—

(a)

has been granted an EU marketing authorisation or a marketing authorisation in an EEA State under the 2001 Directive; and

(b)

is essentially similar to a product that has been granted a UK marketing authorisation;]

“relevant medicinal product” means a medicinal product that is not—

(a)

a registrable homoeopathic medicinal product; or

(b)

a traditional herbal medicinal product; and

[F4 “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;]

[F5 (3) In this Part, references to a medicinal product to be imported that is “essentially similar to a product that has been granted a UK marketing authorisation” are to be read as references to a medicinal product to be imported that—

(a) has been manufactured to the same formulation as a product that has been granted a UK marketing authorisation (“the UK product”);

(b) contains the same active ingredients as the UK product;

(c) has the same therapeutic effect as the UK product,

and for the purposes of sub-paragraph (a), any differences in a product's formulation are to be ignored in so far as they are considered to be immaterial by the licensing authority.

(4) For the purposes of the definition of generic medicinal product—

(a) the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy; and

(b) the various immediate-release oral pharmaceutical forms are considered to be the same pharmaceutical form.

(5) When a medicinal product has been granted a UK marketing authorisation under regulation 49(1)(a) in accordance with the provisions of regulation 50 (“initial marketing authorisation”), any additional strengths, pharmaceutical forms, administration routes, presentations, variations and extensions in relation to which a UK marketing authorisation is granted under regulation 49(1)(a), or which are included in the initial UK marketing authorisation, belong to the same “global marketing authorisation”.

(6) Paragraph (7) applies if a medicinal product—

(a) belongs to a global marketing authorisation but is not the initial marketing authorisation; and

(b) is used as a reference medicinal product in accordance with regulations 51 to 53B.

(7) Where this paragraph applies, the medicinal product is treated for the purposes of the application of regulation 51A(1) and (6) as if it had been authorised on the date of authorisation of the medicinal product to which the initial marketing authorisation relates.

(8) Paragraph (9) applies in relation to a medicinal product if—

(a) it is an EU reference medicinal product;

(b) it is used as a reference medicinal product in accordance with regulations 51 to 53B; and

(c) it belongs to a global marketing authorisation, as described in the second paragraph of Article 6(1) of the 2001 Directive; but

(d) it is not the initial marketing authorisation for the purposes of that global marketing authorisation.

(9) Where this paragraph applies, the medicinal product is treated for the purposes of the application of regulation 51A(1) and (6) as if it had been authorised on the date of authorisation of the initial marketing authorisation for the purposes of the global marketing authorisation to which the product belongs.]

Textual Amendments

F1 Words in reg. 48(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(a)(i)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 48(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(b)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 48(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 48(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(d) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(c)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Reg. 48(3)-(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(d)); 2020 c. 1, Sch. 5 para. 1(1)