Medicines Act 1968

37 Transitional provisions as to clinical trials and medicinal tests on animals. U.K.

(1) The provisions of sections 31, 32, 34 and 36 of this Act shall have effect subject to the following provisions of this section.

(2) The restrictions imposed by sections 31 and 32 of this Act do not apply to anything done before the first appointed day, and the restrictions imposed by section 34 of this Act do not apply where the substance or article in question was administered before that day.

(3) Where, in the course of a series of investigations carried out during a period ending on the first appointed day,—

(a) medicinal products of a particular description have been administered by way of a clinical trial, or

(b) substances or articles have been administered by way of a medicinal test on animals,

the restrictions imposed by section 31 or section 32 of this Act do not apply to anything done in relation to medicinal products of that description or (as the case may be) in relation to similar substances or articles for the purpose of continuing that series of investigations, if it is done on or after the first appointed day but before such date as may be appointed for the purposes of this section by an order made by the Ministers.

(4) If, on an application for a clinical trial certificate or an animal test certificate which is made before the date appointed for the purposes of this section, it is proved to the reasonable satisfaction of the licensing authority that—

(a) medicinal products of a description specified in the application were administered by way of a clinical trial or (as the case may be) substances or articles so specified were administered by way of a medicinal test on animals in the course of a series of investigations as mentioned in subsection (3) of this section, and

(b) that series of investigations was in progress immediately before the first appointed day, and

(c) the certificate is required for the purpose of continuing the series,

the applicant shall be entitled to the issue of a certificate such as will enable the series to be continued and completed within a reasonable time after the date appointed for the purposes of this section.

(5) Section 36(3) of this Act shall not have effect in relation to any application for a certificate as being a certificate to which the applicant is entitled by virtue of subsection (4) of this section; but the provisions of section 27 of this Act shall have effect in relation to any such application, as if—

(a) any reference in that section to a licence of right were a reference to such a certificate;

(b) for the reference in subsection (2)(a) of that section to the grounds of refusal therein mentioned there were substituted a reference to the grounds that the conditions specified in subsection (4) of this section have not been fulfilled in relation to the application; and

(c) in subsection (6) of that section the reference to sections 25 and 26 of this Act were a reference to subsection (4) of this section;

and for the purposes of the application of those provisions in accordance with this subsection the relevant date, in relation to any matters specified in the application, shall be the date appointed for the purposes of this section.

Modifications etc. (not altering text)

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

C2 Ss. 32-39 modified (1.1.1995) by S.I. 1994/3142, reg. 18(4)