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PART 5U.K.Marketing authorisations

Application for UK marketing authorisationU.K.

Application for grant of UK marketing authorisation [F1or parallel import licence] U.K.

49.—[F2(1) The licensing authority may grant—

(a)subject to regulation 58, a UK marketing authorisation; or

(b)a parallel import licence,

for a relevant medicinal product in response to an application made in accordance with this Part.]

(2) A marketing authorisation [F3or parallel import licence] granted under paragraph (1) shall contain terms approved by the licensing authority.

(3) The applicant must be established in the European Union.

(4) The application must be—

(a)made in writing;

(b)signed by or on behalf of the applicant; and

(c)unless the licensing authority directs otherwise, accompanied by any fee payable in connection with the application.

(5) An application is treated as signed for the purposes of paragraph (4)(b) if it is signed with an electronic signature.

(6) The application and any accompanying material must be in English.

(7) The application must include a statement indicating whether the product to which the application relates should be available—

(a)only on prescription;

(b)only from a pharmacy; or

(c)on general sale.

(8) The application must include a statement indicating—

(a)whether any terms of the authorisation are proposed relating to the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product); and

(b)if so, what terms are proposed.

Textual Amendments

F1Words in reg. 49 heading inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 49 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(a)