46 Special defences under s. 45. U.K.
(1)Where the holder of a product licence or of [F1an animal test certificate] is charged with an offence under the last preceding section in respect of any substance or article which has been manufactured (or, in the case of a medicinal product, manufactured or assembled) to his order by another person and has been so manufactured or assembled as not to comply with the provisions of that licence or certificate which are applicable to it, it shall be a defence for him to prove—
(a)that he had communicated those provisions to that other person, and
(b)that he did not know, and could not by the exercise of reasonable care have discovered, that those provisions had not been complied with.
(2)Where the holder of a manufacturer’s licence is charged with an offence under the last preceding section in respect of any medicinal products which have been manufactured or assembled by him, in circumstances where he is not the holder of a product licence or of [F1an animal test certificate] which is applicable to those products, but the products were manufactured or assembled to the order of another person, it shall be a defence for him to prove that he believed, and had reasonable grounds for believing,—
(a)that the other person in question was the holder of a product licence applicable to those products, or of [F1an animal test certificate] applicable to them, and
(b)that the products were manufactured or assembled in accordance with that product licence or certificate.
(3)–(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F2
Textual Amendments
F1Words in s. 46 substituted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 14
F2S. 46(3)(4) repealed by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 16, Sch. 1 para. 3(3), Sch. 2
Modifications etc. (not altering text)
C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)
C2S. 46 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4
C3S. 46 amendment to earlier affecting provision SI 1994/105 Sch. 4 (30.10.2005) by Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 (S.I. 2005/2753), regs. 1(1), 19(2)
C4S. 46(1) applied (wth modifications)(3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.