The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005

Interpretation

5.—(1) Regulation 4(1) shall not apply to the placing on the market by way of supplying of any traditional herbal medicinal product to which this paragraph relates if the conditions of sub-paragraph (2) are satisfied.

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

(a) that the traditional herbal 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 administered 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 traditional herbal 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 traditional herbal 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 traditional herbal 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 supply is in response to a bona fide unsolicited order;

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

(f) that the traditional herbal medicinal product is manufactured by the holder of a manufacturer’s licence which relates specifically to the manufacture of traditional herbal medicinal products to which paragraph 2 applies.