Medicines Act 1968

36 Application for, and issue of, certificate. U.K.

(1)Any application for a clinical trial certificate or an animal test certificate shall be made to the licensing authority and shall be made in such form and manner, and shall contain, or be accompanied by, such information, documents, samples and other material, as may be prescribed.

(2)In dealing with any such application, the licensing authority shall have regard in particular to any evidence available to them as to any risks involved in the proposed clinical trial or medicinal test on animals.

(3)Subject to the next following section, the provisions of sections 20 to 22 of this Act shall have effect in relation to applications for clinical trial certificates or animal test certificates, as if in those sections any reference to a licence under this Part of this Act were a reference to such a certificate.

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. 36 applied (with modifications) (2.8.1999) by S.I. 1999/1871, reg. 92(3)