Version Superseded: 01/10/2006
Point in time view as at 01/05/2004. This version of this provision has been superseded.
Medicines Act 1968, Section 39 is up to date with all changes known to be in force on or before 10 March 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
(1)Subject to the following provisions of this section, the licensing authority may suspend, for such period as the authority may determine, [F1an animal test certificate], or may revoke, or vary the provisions of, any such certificate.
(2)The powers conferred by this section shall not be exercisable by the licensing authority except on one or more of the following grounds, that is to say—
(a)that the matters stated in the application on which the certificate was issued were false or incomplete in a material particular;
(b)that any of the provisions of the certificate has to a material extent been contravened;
(c)that medicinal products of any description to which the certificate relates, as sold, supplied, exported, imported, manufactured or assembled for the purposes of the F2... medicinal test on animals to which it relates, fail to a material extent to correspond to the characteristics by reference to which the certificate was issued;
(d)that the holder of the certificate has without reasonable excuse failed to comply with a requirement imposed on him under section 44(2) of this Act to furnish information to the licensing authority with respect to any substances or articles to which the certificate relates;
(e)that any such substances or articles can no longer be regarded as substances or articles which can safely be administered for the purposes of the F3... medicinal test on animals to which the certificate relates;
(f)that the specification and standards to which any such substances or articles are manufactured can no longer be regarded as satisfactory.
(3)The provisions of section 29 of, and Schedule 2 to, this Act shall have effect in relation to [F4an animal test certificate] as they have effect in relation to a product licence, as if in paragraph 1 of that Schedule the reference to paragraph (g) or paragraph (h) of section 28(3) of this Act were a reference to paragraph (e) or paragraph (f) of subsection (2) of this section.
(4)Without prejudice to any power exercisable by virtue of the preceding provisions of this section, the licensing authority may, on the application of the holder of [F5an animal test certificate], vary the provisions of the certificate in accordance with any proposals contained in the application, if they are satisfied that the variation will not adversely affect the safety, quality or efficacy of medicinal products of any description to which the certificate relates.
Textual Amendments
F1Words in s. 39(1) substituted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 11(a)
F2Words in s. 39(2)(c) omitted (1.5.2004) by virtue of Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 11(b)
F3Words in s. 39(2)(e) omitted (1.5.2004) by virtue of Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 11(b)
F4Words in s. 39(3) substituted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 11(a)
F5Words in s. 39(4) substituted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 11(a)
Modifications etc. (not altering text)
C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)
C2Ss. 32-39 modified (1.1.1995) by S.I. 1994/3142, reg. 18(4)
C3S. 39 applied (with modifications) (2.8.1999) by S.I. 1999/1871, reg. 92(3)
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