Regulation 7 Insertion of regulation 3B into the Leaflets Regulations

After regulation 3A of the Leaflets Regulations, there shall be inserted the following regulation—

“Standard requirements relating to leaflets for homoeopathic products

3B

Subject to the following provisions of these regulations, any leaflet which is enclosed in or supplied with the packaging of a proprietary medicinal product which is a homoeopathic product to which Council Directive 92/73/EEC applies and which is placed on the market in the United Kingdom in accordance with a certificate of registration, shall, in addition to clear mention of the words “homoeopathic medicinal product”, contain the particulars set out in Schedule 3 to these regulations and no other particulars.”.