The Medicines (Medicines Act 1968 Amendment) Regulations 1983

Amendment of section 7 of the Act

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

(2) For subsection (5)(b) there shall be substituted—

“(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.”

(3) For subsection (7) there shall be substituted—

“(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 70/524/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 70/524/EEC apply.”

(1)

Section 7 was amended by S.I. 1977/1050 and S.R. (N.I.) 1977 No. 170.