PART 5U.K.Marketing authorisations

Application of this PartU.K.

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

(2) In this Part—

F1...

[F2“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 [F353B(1)];]

[F4“generic medicinal product”, in relation to a reference medicinal product for an application for—

(a)

a UKMA(NI) or [F5UKMA(UK)(Category 2)], has the meaning given in Article 10(2)(b) of the 2001 Directive;

(b)

a [F6UKMA(UK)(Category 1)], 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;]

[F7“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

[F8“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)

F9...

(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[F10, ]

(ii)

F11...

but which is not an excluded reference product;]

[F12(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 [F1351B(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.

F14(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ]

Textual Amendments