Amendment of regulation 3(1) of the Labelling Regulations
2. In regulation 3(1) of the Labelling Regulations (interpretation)—
(a)after the definition of “homoepathic product”, there shall be inserted the following definition—
““homoeopathic product to which Council Directive 92/73/EEC(1) applies” means a medicinal product for human use (which may contain a number of principles) prepared from products, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State, other than one—
(i)prepared in accordance with a magistral or officinal formula as defined in Article 1(4) and (5) of the 1965 Directive, or
(ii)which satisfies the criteria laid down in Article 2(4) of the 1965 Directive;”;
(b)in the definition of “product to which Chapters II to V of the 1965 Directive apply”(2) for “and Article 1 of Council Directive 89/381/EEC(e)” there shall be substituted “, Article 1 of Council Directive 89/381/EEC(e) and Article 9(1) of Council Directive 92/73/EEC”.
OJ No. L297, 13.10.92, p. 8.
Definition inserted by regulation 2(4) of S.I. 1992/3273.