Medicines Act 1968

23 Special provisions as to effect of manufacturer’s licence. U.K.

(1) Subject to the provisions of this Part of this Act relating to F1 ... medicinal tests on animals and to the following provisions of this section, a manufacturer’s licence shall not have effect so as to authorise the manufacture or assembly of medicinal products of any description for sale or supply to any other person, or for exportation, unless either—

(a) the holder of the licence is also the holder of a product licence which is applicable to medicinal products of that description, or

[F2 (b) the products are manufactured or assembled to the order of—

(i) a person who is the holder of such a product licence, or

(ii) if the products are to be used for the purposes of a clinical trial, the sponsor of that trial,]

and (in either case) the products are manufactured or assembled in accordance with that product licence.

(2) Subject to the next following subsection, the preceding subsection shall not have effect in relation to the manufacture or assembly of any medicinal product to the order of a practitioner, where the practitioner—

(a) being a doctor or dentist, states that the product is required for administration to a patient of his or is required, at the request of another doctor or dentist, for administration to a patient of that other doctor or dentist, or

(b) being a veterinary surgeon or veterinary practitioner, states that the product is required for administration to an animal or herd which is under his care or is required, at the request of another veterinary surgeon or veterinary practitioner, for administration to an animal or herd which is under the care of that other veterinary surgeon or veterinary practitioner,

and shall not have effect in relation to the manufacture or assembly of any medicinal product to the order of a pharmacist in accordance with a prescription given by a practitioner.

(3) The exemption conferred by the last preceding subsection—

(a) in a case falling within paragraph (b) of that subsection, or

(b) in so far as it relates to the manufacture or assembly of a medicinal product to the order of a pharmacist,

does not apply to a vaccine specially prepared for administration to poultry.

(4) If by virtue of an order made under section 15 of this Act an exemption is conferred in respect of the restrictions imposed by section 7 of this Act, but no corresponding exemption is conferred in respect of the restrictions imposed by section 8(2) of this Act, the order may provide that subsection (1) of this section shall have effect subject to such exceptions or modifications as the Ministers consider appropriate in the circumstances.

(5) Where subsection (1) of this section has effect in relation to medicinal products of any description, and the conditions specified in that subsection are not fulfilled, the manufacture or assembly of medicinal products of that description for sale or supply to another person, or for exportation, notwithstanding that it complies with the provisions contained in the manufacturer’s licence, shall for the purposes of this Act be deemed to be not in accordance with that licence.

[F3 (6) In this section, “clinical trial” and “sponsor”, in relation to a clinical trial, have the meaning given by Clinical Trials Regulations.]

Textual Amendments

F1 Words in s. 23(1) omitted (1.5.2004) by virtue of Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 5(2)(a)

F2 S. 23(1)(b) substituted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 5(2)(b)

F3 S. 23(6) inserted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 5(3)

Modifications etc. (not altering text)

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

C2 S.23 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

S. 23 modified (1.1.1995) by S.I. 1994/3144, reg.9(3)

S. 23 applied (1.1.1995) by S. I. 1994/3142, reg. 18(2)

S. 23 amended (E.W.S.) (prosp.) by 1954 c. 61, s. 13I para. 1(b) (as inserted (prosp.) by 1997 c. 19, ss. 1,2, Sch. para.2)