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Medicines Act 1968
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Rhagor o Adnoddau
Changes over time for: Section 39
Version Superseded: 01/05/2004
Alternative versions:
- 01/02/1991- Amendment
- 01/02/1991
Point in time - 01/05/2004- Amendment
- 01/10/2006- Amendment
- 14/08/2012- Amendment
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39 Suspension, revocation or variation of certificate. U.K.
(1)Subject to the following provisions of this section, the licensing authority may suspend, for such period as the authority may determine, a clinical trial certificate or 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 clinical trial or 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 clinical trial or 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 a clinical trial certificate or 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 a clinical trial certificate or 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.
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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