Part II U.K. Licences and Certificates Relating to Medicinal Products

Applications for, and grant and renewal of, licences U.K.

Modifications etc. (not altering text)

C1 Definitions in ss. 18-22 applied (N.I.) (1.4.1992) by S.I. 1991/194 (N.I. 1), art. 7(2), Sch. 2 para. 5(4); S.R. 1991/131, art. 2(e), Sch. Pt.III

20 Grant or refusal of licence. U.K.

(1) Subject to the last preceding section, and to the following provisions of this Act, on any application to the licensing authority for a licence under this Part of this Act the licensing authority—

(a) may grant a licence containing such provisions as they consider appropriate, or

(b) if, having regard to the provisions of this Act [F1 and any Community obligation], they consider it necessary or expedient to do so, may refuse to grant a licence.

(2) The licensing authority shall not refuse to grant such a licence on any grounds relating to the price of any product, and shall not insert in any such licence any provisions as to the price at which any product may be sold, supplied, imported or exported.

(3) The licensing authority shall not refuse to grant such a licence on any grounds relating to the safety, quality or efficacy of medicinal products of any description, except after consultation with the appropriate committee or, if for the time being there is no such committee, with the Commission.

(4) Where the licensing authority grant a licence under this Part of this Act, they shall send a copy of the licence to every committee established under section 4 of this Act whose functions consist of or include the giving, in relation to medicinal products of any description to which the licence relates, of advice with respect to safety, quality or efficacy, or, if for the time being there is no such committee, the licensing authority shall send a copy of the licence to the Commission.

(5) Where on an application for a licence under this Part of this Act—

(a) the licensing authority refuse to grant a licence, or

(b) the licensing authority grant a licence otherwise than in accordance with the application, and the applicant requests the licensing authority to state their reasons,

the licensing authority shall serve on the applicant a notice stating the reasons for their decision.

Textual Amendments

F1 Words inserted by (E.W.) S.I. 1977/1050, art. 4(3) and (N.I.) S.R. 1977 No. 170, reg. 5(3)

Modifications etc. (not altering text)

C2 Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C3 Ss. 20-22 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.

C4 Definitions in ss. 18-22 applied (N.I.) (1.4.1992) by S.I. 1991/194, (N.I. 1), art. 7(2), Sch. 2 para. 5(4); S.R. 1991/131, art. 2(e), Sch. Pt.III