Medicines Act 1968

19 Factors relevant to determination of application for licence. U.K.

(1) Subject to the following provisions of this Part of this Act, in dealing with an application for a product licence the licensing authority shall in particular take into consideration—

(a) the safety of medicinal products of each description to which the application relates;

(b) the efficacy of medicinal products of each such description for the purposes for which the products are proposed to be administered; and

(c) the quality of medicinal products of each such description, according to the specification and the method or proposed method of manufacture of the products, and the provisions proposed for securing that the products as sold or supplied will be of that quality.

(2) In taking into consideration the efficacy for a particular purpose of medicinal products of a description to which such an application relates, the licensing authority shall leave out of account any question whether medicinal products of another description would or might be equally or more efficacious for that purpose:

Provided that nothing in this subsection shall be construed as requiring the licensing authority, in considering the safety of medicinal products of a particular description, in relation to a purpose for which they are proposed to be administered, to leave out of account any question whether medicinal products of another description, being equally or more efficacious for that purpose, would or might be safer in relation to that purpose.

(3) Where any such application indicates that the purposes for which the licence is required relate (wholly or partly) to medicinal products which have been or are to be imported, then in dealing with the application, in so far as it relates to such products, the licensing authority shall also take into consideration in particular the methods, standards and conditions of manufacture of those products and may, if they think fit, require the production by the applicant of any one or more of the following, that is to say—

(a) an undertaking, given by the manufacturer of any such products, to permit the premises where they are or are to be manufactured, and the operations carried on or to be carried on in the course of manufacturing them, to be inspected by or on behalf of the licensing authority;

(b) an undertaking, given by or on behalf of the manufacturer of any such products, to comply with any prescribed conditions or any conditions attached to the licence by the licensing authority;

(c) a declaration, given by or on behalf of the manufacturer of any such products, that, in relation to the manufacture of those products, any requirements imposed by or under the law of the country in which they are or are to be manufactured have been or will be complied with.

(4) Where any such application indicates that the purposes for which the license is required relate exclusively to the exportation of medicinal products, the licensing authority shall leave out of account considerations of safety and efficacy (as mentioned in paragraphs (a) and (b) of subsection (1) of this section) if satisfied that in the circumstances it is reasonable to do so.

(5) In dealing with an application for a manufacturer’s licence the licensing authority shall in particular take into consideration—

(a) the operations proposed to be carried out in pursuance of the licence:

(b) the premises in which those operations are to be carried out;

(c) the equipment which is or will be available on those premises for carrying out those operations;

(d) the qualifications of the persons under whose supervision those operations will be carried out; and

(e) the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products manufactured or assembled in pursuance of the licence.

(6) In dealing with an application for a wholesale dealer’s licence the licensing authority shall in particular take into consideration—

(a) the premises on which medicinal products of the descriptions to which the application relates will be stored;

(b) the equipment which is or will be available for storing medicinal products on those premises;

(c) the equipment and facilities which are or will be available for distributing medicinal products from those premises; and

(d) the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products stored on or distributed from those premises.

(7) The preceding provisions of this section shall have effect subject to the provisions of this Part of this Act relating to licences of right.

Modifications etc. (not altering text)

C1 Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C2 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. 1991/194, art. 2(e), Sch. Pt. III

C3 S. 19 (1)(2)(3) applied (with modifications) by S.I. 1992/605, reg. 2(1)(2),Sch.