Explanatory Note
(This note is not part of the Regulations)
These Regulations further amend the Medicines Act 1968 (“the Act”) to implement in part Council Directive 92/73/EEC (“the Homoeopathic Directive”) (OJ L 297, 13.10.92, p. 8) which widens the scope of Directives 65/65/EEC (OJ No. 22, 9.2.1965, p. 369/65) and 75/319/EEC (OJ No. L 147, 9.6.1975, p. 13) on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homoeopathic medicinal products and Council Directive 92/27/EEC (OJ No. L113, 30.4.92, p. 8) (“the Labelling Directive”) which concerns the labelling of, and leaflets to be provided with, medicinal products.
Regulation 2 revokes the Medicines Act 1968 (Amendment) Regulations 1994 (S.I. 1994/101), regulations 2(3), 3(2) and 6(1) of which were defective. These Regulations replace those; the opportunity has been taken (regulation 7(2)) to clarify the application of regulation 7(1).
Regulation 3 amends section 7 of the Act by adding two new subsections, (2A) which provides that as regards a product in respect of which a certificate of registration has been granted, no requirement arises under section 7, and (2B) which expands the activities caught by section 7(2) to include the placing on the market of a product without such a certificate (see Article 7 of the Homoeopathic Directive). Definitions of the terms “certificate of registration” and “homoeopathic medicinal product” have also been inserted.
Regulation 4 amends section 8 of the Act by removing the exemption from the requirement to obtain a wholesale dealer’s licence for homoeopathic medicinal products for human use which have been imported but not consigned from a member State of the European Community (Article 3 of the Homoeopathic Directive).
Regulation 5 amends section 24 of the Act so as to ensure that the requirements of the Labelling Directive are properly taken into account when an application for renewal of a licence under Part II of the Act is considered (Article 10(2) of the Labelling Directive).
Regulation 6 amends section 28 of the Act by providing for the suspension of a product licence for a medicinal product to which Chapters II to V of the 1965 Directive apply where there is a material contravention of section 86(4) of the Act or of regulations made under the Act concerning leaflets and labelling (Article 11 of the Labelling Directive).
Regulation 7 inserts a new subsection (4) in section 86 of the Act to require, in accordance with Article 6 of the Labelling Directive, that no medicinal product to which Chapters II to V of the 1965 Directive apply is to be supplied unless a leaflet containing specified information is enclosed in, or supplied with, the package, or the package itself carries that information.
Regulation 8 amends section 91 of the Act; the amendments have effect only to provide that contravention of section 86(4) is an offence.
Regulation 9 makes a consequential amendment to the definition of the 1965 Directive in section 132(1) of the Act.
Other parts of the Homoeopathic 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 (Standard Provisions for Licences and Certificates) Amendment Regulations 1994 (S.I. 1994/103).
Other parts of the Labelling Directive are implemented by the Medicines (Labelling) Amendment Regulations 1992 (S.I. 1992/3273) and the Medicines (Leaflets) Amendment Regulations 1992 (S.I. 1992/3274).