The Medicines Act 1968 (Amendment) Regulations 1992

Amendment of section 7 of the Act

2.—(1) Section 7(1) of the Act (general provisions as to dealing with medicinal products) shall be amended as follows.

(2) In subsection (5)(b) (under which a person responsible for the placing of certain kinds of medicinal product on the market in the United Kingdom is required to have a product licence) for “or ready-made veterinary drug” there shall be substituted “, a ready-made veterinary drug or an industrially produced medicinal product other than a veterinary drug”.

(3) After subsection (6) there shall be inserted—

“(6A) Where the product which a person is responsible for placing on the market in the United Kingdom is not a veterinary drug, subsection (5)(b) of this section shall not apply if the product is—

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

(b) a radiopharmaceutical in which the radionuclide is in the form of a sealed source, or

(c) a homoeopathic medicinal product.

(6B) Where the product which a person is responsible for placing on the market in the United Kingdom is a veterinary drug, subsection (5)(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(2) apply.”.

(4) In subsection (7) (definitions) for the words from the beginning to “(b)” there shall be substituted—

• “In this section—

• “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;

• “radiopharmaceutical” means a medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose; and”.

(5) In that subsection, in the definition of “ready-made veterinary drug”, the words from “and for the purposes of this definition” to the end are hereby repealed.

(1)

Section 7 has been amended by S.I. 1977/1050 and S.I. 1983/1724.

(2)

OJ No. L270, 14.12.70, p. 1.