Amendment of regulation 2(1) of the Leaflets Regulations5
1
Regulation 2(1) of the Leaflets Regulations (interpretation) shall be amended in accordance with the following paragraphs of this regulation.
2
After the definition of “the Act”there shall be inserted the following definition—
“certificate of registration” means a certificate granted under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;
3
After the definition of “generator” there shall be inserted the following definitions—
“homoeopathic medicinal product” means a medicinal product (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;
“homoeopathic product to which Council Directive 92/73/EEC10 applies” means a homoeopathic medicinal product for human use 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;
4
In the definition of “product to which Chapters II to V of the 1965 Directive apply”11 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”.
5
In the definition of “proprietary medicinal product”, for “but does not include a homoeopathic medicinal product or” there shall be substituted “including a homoeopathic product to which Council Directive 92/73/EEC applies, but does not include a”.