The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

4.—(1) Regulation 3(1) shall not apply to the placing on the market by way of supplying of any relevant medicinal product to which this paragraph relates if the conditions of sub-paragraph (3) are satisfied.

(2) The relevant medicinal products to which this paragraph relates are relevant medicinal products which are for use by being administered to one or more human beings and which may be lawfully sold by retail or supplied in circumstances corresponding to retail sale, otherwise than in accordance with a prescription by a doctor or dentist.

(3) The conditions referred to in sub-paragraph (1) are—

(a) that the relevant medicinal product is sold or supplied to a person exclusively for use by him in the course of a business carried on by him for the purposes of administering it or causing it to be adminstered to one or more human beings otherwise than by selling it;

(b) that, if sold or supplied through the holder of a wholesale dealer’s licence, the relevant medicinal product is sold or supplied to such a person, and for such use by him, as is described in head (a) above;

(c) that, where the manufacture or assembly of the relevant medicinal product is procured, it is procured by such a person, and for such use by him, as is described in head (a) above;

(d) that no advertisement or representation relating to the relevant medicinal product is issued with a view to it being seen generally by the public in the United Kingdom and that no advertisement relating to that product, by means of any catalogue, price list or circular letter, is issued by, at the request or with the consent of, the person selling that product by retail or by way of wholesale dealing or supplying it in circumstances corresponding to retail sale, or the person who manufactures it, and that the sale or supply is in response to a bona fide unsolicited order;

(e) that the relevant medicinal product is prepared by or under the supervision of a pharmacist; and

(f) that the relevant medicinal product is manufactured by the holder of a manufacturer’s licence which relates specifically to the manufacture of relevant medicinal products to which paragraph 1 applies.