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Medicines Act 1968

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8 Provisions as to manufacture and wholesale dealing. E+W+S+N.I.

(1)The following provisions of this section shall have effect without prejudice to the operation of section 7 of this Act, but subject to the exemptions and provisions referred to in paragraphs (a) to (c) of subsection (1) of that section.

(2)No person shall, in the course of a business carried on by him, manufacture or assemble any medicinal product except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a “manufacturer’s licence”).

[F1(3)[F2Subject to subsection (3C) of this section,] no person shall, in the course of a business carried on by him—

(a)sell, or offer for sale, any medicinal product by way of wholesale dealing, or

(b)distribute, otherwise than by way of sale, any proprietary medicinal product [F3, ready-made veterinary drug or industrially produced medicinal product other than a veterinary drug] which has been imported, but was not consigned from a member State,

except in accordance with a [F4wholesale dealer’s licence].]

[F5(3A)Without prejudice to the generality of subsection (3) of this section but subject to subsection (3C), no person shall, in the course of a business carried on by him, distribute by way of wholesale dealing a product to which [F6the 2001 Directive applies] apply except in accordance with a wholesale dealer’s licence.

(3B)Distribution of such a product by way of wholesale dealing shall not be taken to be in accordance with a wholesale dealer’s licence unless, in particular, it occurs in the course of a business which is carried on at a place or places specified in the licence.

(3C)The restrictions imposed by subsections (3) and (3A) of this section do not apply to anything done in relation to a product to which [F6the 2001 Directive applies] apply by the holder of a manufacturer’s licence in respect of it.]

[F7(4)Where the product which a person distributes is not a veterinary drug, subsection (3)(b) of this section shall not apply if the product is—

(a)whole human blood, human blood plasma or blood cells of human origin, [F8or]

(b)a radiopharmaceutical in which the radionuclide is in the form of a sealed source, [F9. . .]

F9(c). . .

(5)Where the product which a person distributes is a veterinary drug, subsection (3)(b) of this section shall not apply if the product is—

(a)a vaccine, toxin or serum,

(b)a product based on radioactive isotopes,

(c)a product specially prepared for administration by a veterinary surgeon or veterinary practitioner to a particular animal or herd which is under his care,

(d)a homoeopathic medicinal product, or

(e)an additive for animal feeding stuffs to which the provisions of Council Directive 70/524/EEC apply.

(6)In this section, [F10homoeopathic medicinal product,]“proprietary medicinal product”, “radiopharmaceutical” and “ready-made veterinary drug” have the same meanings as in section 7 of this Act.]

[F11(7)In this section any reference to distribution of a product by way of wholesale dealing is a reference to—

(a)selling or supplying it, or

(b)procuring, holding or exporting it for the purposes of sale or supply,

to a person who receives it for the purposes of—

(i)selling or supplying it, or

(ii)administering it or causing it to be administered to one or more human beings,

in the course of a business carried on by that person.

(8)In this Act any reference to a wholesale dealer’s licence is a reference to a licence granted for the purposes of subsection (3) or (3A) of this section.]

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Amendments (Textual)

F1S. 8(3)(4) substituted for s. 8(3) by (E.W.)(S.) S.I. 1977/1050, art. 3(2) and (N.I.) S.R. 1977 No. 170, reg. 4

F2Words in s. 8(3) inserted (14.4.1993) by S.I. 1993/834, reg. 2(2)

F3Words in s. 8(3)(b) substituted (3.4.1992) by virtue of S.I.1992/604, regs. 3(2), 4

F4Words in s. 8(3) substituted (14.4.1993) by S.I. 1993/834, reg. 2(3)

F5S. 8(3A)-(3C) inserted (14.4.1993) by S.I. 1993/834, reg. 2(4)

F6Words in s. 8(3A)(3C) substituted (28.2.2002) by S.I. 2002/236, reg. 2(a)(i)

F7S. 8(4)(5)(6) substituted (3.4.1992) for s. 8(4) by virtue of S.I. 1992/604, regs. 3(3), 4

F8Word in s. 8(4) inserted (13.2.1994) at the end of para.(a) by S.I. 1994/276, reg. 4(2)(a)( which S.I. revoked and replaced defective S.I. 1994/101, before the later S.I. came into force)

F9In S. 8(4) paragraph (c) and words immediately preceeding it omitted (13.2.1994) by virtue of S.I. 1994/276, reg. 4(2)(b) (which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)

F10Words in s.8(6) inserted (13.2.1994) by S.I. 1994/276, reg. 4(3) (which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)

F11S. 8(7)(8) added (14.4.1993) by S.I. 1993/834, reg. 2(5)

Modifications etc. (not altering text)

C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C6S. 8(3)(b) excluded by S.I. 1989/2322, art. 2(3)

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