The Medicines Act 1968 (Amendment) Regulations 1992

Amendment of section 8 of the Act

3.—(1) Section 8 of the Act(1)(which contains provisions as to manufacture and wholesale dealing) shall be amended as follows.

(2) In subsection (3)(b) (under which a person who distributes certain medicinal products otherwise than by way of sale is required to have a wholesale dealer’s licence) for “or ready-made veterinary drug” there shall be substituted “, ready-made veterinary drug or industrially produced medicinal product other than a veterinary drug”.

(3) For subsection (4) (which applies definitions contained in section 7(7)) there shall be substituted—

“(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,

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

(c) a homoeopathic medicinal product.

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

(1)

Section 8 has been amended by S.I. 1977/1050 and 1983/1724.