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

2.  The conditions mentioned in paragraph 1 are that—

(a) the relevant medicinal product is supplied to a doctor or dentist or for use in a registered pharmacy, a hospital or a health centre under the supervision of a pharmacist, in accordance with paragraph 1;

(b) 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;

(c) the manufacture or assembly of the relevant medicinal product is carried out under the supervision of such staff and such precautions are taken as are adequate to ensure that the product is of the character required by and meets the specifications of the doctor or dentist who requires it;

(d) written records as to the manufacture or assembly in accordance with sub-paragraph (c) are made and maintained and are available to the licensing authority or the enforcement authority on request by them or either of them;

(e) the relevant medicinal product is manufactured, assembled or imported by the holder of an authorization referred to in Article 16 of Council Directive 75/319/EEC which relates specifically to the manufacture, assembly or import of relevant medicinal products to which paragraph 1 applies; and

(f) the relevant medicinal product is distributed by way of wholesale dealing by the holder of a wholesale dealer’s licence.