The Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995

Advisory Board on the Registration of Homoeopathic Products

2.—(1) The Advisory Board on the Registration of Homoeopathic Products, provision for the establishment of which was made by article 2 of the Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1994(1), is a committee established for the purpose of giving advice with respect to the safety and quality of—

(a) any homoeopathic medicinal product in respect of which the conditions set out in paragraph (2) below are met; and

(b) any homoeopathic medicinal product which satisfies the conditions set out in Article 7 of Council Directive 92/74/EEC(2),

and to which any provision of the Medicines Act 1968 is applicable.

(2) The conditions referred to in paragraph (1)(a) above are that:

(a) the product is one to which Article 2(1) of Council Directive 92/73/EEC(3) applies;

(b) the product is for oral or external administration;

(c) no specific therapeutic indication appears on the labelling of the product or in any information relating thereto;

(d) the product is one in respect of which—

(i) an application for a certificate of registration has been made in accordance with regulation 4(1) of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, or

(ii) an application for the renewal of such a certificate has been made in accordance with regulation 8(3) of those Regulations, or

(iii) the licensing authority proposes to suspend or revoke the certificate of registration.

(1)

S.I. 1994/102.

(2)

OJ No. L297, 13.10.92, p.12. This Directive widens the scope of Council Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homoeopathic veterinary medicinal products.

(3)

OJ No. L297, 13.10.92, p.8.