(1)The following provisions of this section shall have effect subject to—
(a)any exemption conferred by or under this Part of this Act;
(b)the provisions of this Part of this Act relating to clinical trials and medicinal tests on animals; and
(c)the provisions of section 48 of this Act.
(2)Except in accordance with a licence granted for the purposes of this section (in this Act referred to as a “product licence") no person shall, in the course of a business carried on by him, and in circumstances to which this subsection applies,—
(a)sell, supply or export any medicinal product, or
(b)procure the sale, supply or exportation of any medicinal product, or
(c)procure the manufacture or assembly of any medicinal product for sale, supply or exportation.
(3)No person shall import any medicinal product except in accordance with a product licence.
(4)In relation to an imported medicinal product, subsection (2) of this section applies to circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product, has himself imported the product or procured its importation.
(5)In relation to any medicinal product which has not been imported, subsection (2) of this section applies to any circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product,
[F1(a)is responsible for the composition of the product, or
[F2(b)if that product is a proprietary medicinal product or a ready-made veterinary drug, is responsible for the placing of the product on the market in the United Kingdom.]
(6)For the purposes of subsection (5) of this section a person shall be taken to be responsible for the composition of a medicinal product if (but only if) in the course of a business carried on by him—
(a)he procures the manufacture of the product to his order by another person, where the order specifies, or incorporates by reference to some other document, particulars of the composition of the product ordered, whether those particulars amount to a complete specification or not, or
(b)he manufactures the product otherwise than in pursuance of an order which fulfils the conditions specified in the preceding paragraph.
[F3(7)In subsection (5) of this section—
(a)“proprietary medicinal product” means a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack; and for the purposes of this definition “medicinal product" does not include—
(i)vaccines, toxins or serums,
(ii)medicinal products based on human blood or blood constituents or radioactive isotopes,
(iii)homoeopathic medicinal products, or
(iv)additives for animal feeding stuffs to which the provisions of Council Directive M170/524/EEC apply;]
(b)“ready-made veterinary drug” means a ready-prepared veterinary drug placed on the market in the United Kingdom in a pharmaceutical form in which it may be used without further processing, not being a drug placed on the market under a special name and in a special pack; and for the purposes of this definition “veterinary drug" does not include—
(i)vaccines, toxins or serums,
(ii)veterinary drugs based on radioactive isotopes,
(iii)veterinary drugs specially prepared for administration by a veterinary surgeon or veterinary practitioner to a particular animal or herd which is under his care,
(iv)homoeopathic veterinary drugs, or
(v)additives for animal feeding stuffs to which the provisions of Council Directive M2 70/524/EEC apply.]
Textual Amendments
F1Words substituted by (E.W.)(S.) S.I. 1977/1050, art. 2(2) and (N.I.) S.R. 1977 No. 170, reg. 3
F2S. 7(5)(b) substituted by S.I. 1983/1724, art. 2(2)
F3S. 7(7) substituted by S.I. 1983/1724, art. 2(3)
Modifications etc. (not altering text)
C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)
C2S. 7 excluded by S.I. 1981/164, art. 3
C3S. 7 excluded by S.I. 1989/2325, art. 2(1)
C4S. 7 excluded (11.12.1992) by S.I. 1992/2844, art.2
Marginal Citations
M1OJ No. L 270. 14.12.70, p. 1.
M2OJ No. L 270. 14.12.70, p. 1.