HL Deb 14 July 1998 vol 592 cc13-4WA
The Countess of Mar

asked Her Majesty's Government:

With reference to the Official Group on OPs—Report to Ministers, paragraph 8.15, whether they will detail specifically the Community law which requires that the competent authority responsible for authorising the placing on the market of veterinary medicines should perform all the functions relating to authorisation and, in particular, that which relates to post marketing surveillance. [HL2556]

Lord Donoughue

Council Directive 81/851/EEC on the approximation of the laws of the member states relating to veterinary medicinal products, as amended by Directives 90/676 and 93/40, places responsibility for applying the relevant provisions of the directive, as implemented in the law of the member state, on the competent authority of the member state.

In particular, Chapter VI of the directive requires the competent authority to undertake the necessary post-marketing supervision.