§ Mr. SteenTo ask the Secretary of State for Health if he will list the directives which have affected his Department in each of the past three years and(a) the United Kingdom legislation introduced as a result of the directives, (b) the United Kingdom legislation which goes beyond the minimum standards set out in the directives and (c) the clauses within each piece of United Kingdom legislation which amplify the minimum standards set out in the directives. [27077]
609W
§ Mr. Horam[holding answer 29 April 1996]In the last three years, three directives have affected this Department. These, and the implementing legislation, are as follows:
Directive Implementing Legislation 93–39 New Licensing system for human medicines The Medicines for Human Use (Marketing Authorisation etc.) Regulation 1994 (SI 1994 No 3144) 93–42 Council Directive on Medical Devices Medical Devices Regulations 1995 (SI 1994 No 3017) The Active Implantable Medical Devices (Amendment and Transitional Provisions Regulations) (SI 1995 No 1671) 93–43 Hygiene of foodstuffs Food safety (General Food Hygiene) Regulations 1995 (SI 1995 No 1763) None of the implementing legislation amplifies the minimum standards set in the directive.