The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994

Explanatory Note

(This note is not part of the Regulations)

These Regulations further amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (“the principal Regulations”) by implementing in part Council Directive 92/73/EEC (OJ No. L297, 13.10.1992, p. 8) (“the Directive”) which widens the scope of Directives 65/65/EEC (OJ No.22, 9.2.1965, p. 369/65) and 75/319/EEC (OJ No. L147, 9.6.1975, p. 13). The latter two Directives relate to the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products; the Directive lays down additional provisions on homoeopathic medicinal products.

Regulation 2 amends the definition of “product to which Chapters II to V of the 1965 Directive apply” and inserts a definition of “certificate of registration”.

Regulation 3 implements Article 3 of the Directive by amending Schedule 2 to the principal Regulations to require the holder of a manufacturer’s licence relating to homoeopathic medicinal products for human use to have a qualified person available to carry out the functions specified in paragraph 16(3) of Schedule 2, including, where appropriate, that of ensuring compliance in specified respects with the certificate of registration and the provisions of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994.

Regulation 4 amends Schedule 3 to the principal Regulations by making similar provision in respect of wholesale dealer’s licences which relate to products imported otherwise than from member States of the European Community and also so as to provide that wholesale dealers may deal only in products which have a certificate of registration, subject to certain exceptions.

Other parts of the Directive are implemented by the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (S. I. 1994/105), the Medicines (Labelling and Leaflets) Amendment Regulations 1994 (S. I.1994/104) and the Medicines Act 1968 (Amendment) Regulations 1994 (S. I.1994/101).