§ Mr. LordTo ask the Minister of Agriculture, Fisheries and Food which other EC countries are implementing a relicensing procedure as part of their enforcement of EEC directive 81/851 on the harmonisation of veterinary products.
§ Mr. SoamesDetails of implementation of directive 81/851/EEC in other member states, is a matter for those member states and the EC Commission. So far as we are aware, however, all member states are reviewing and relicensing, where appropriate, long standing pharmaceutical veterinary medical products in accordance with the terms of the directive.
§ Mr. LordTo ask the Minister of Agriculture, Fisheries and Food what assessment she has made of the uniformity with which the EC directive 81/851 on the harmonisation of veterinary products is being applied throughout the Community.
§ Mr. SoamesThis is a matter for the EC Commission. All member states are required to conduct the review of pharmaceutical veterinary medical products in accordance with the terms of directive 81/851/EEC.
§ Mr. LordTo ask the Minister of Agriculture, Fisheries and Food how many veterinary products have been withdrawn from sale in the United Kingdom as a result of the Veterinary Medicine Directorate's relicensing policy.
§ Mr. SoamesI refer my hon. Friend to the reply given to the hon. Member for Great Grimsby (Mr. Mitchell) on 14 July,Official Report, column 543.
§ Mr. LordTo ask the Minister of Agriculture, Fisheries and Food what information she has on the cost of relicensing veterinary products under EEC directive 81/851(a) in France and (b) in the United Kingdom.
150W
§ Mr. SoamesNo fee is charged for the review of an old product in the United Kingdom. We have no information on whether any fee is payable in France. In both countries, the costs to a company of relicensing a medicine are variable, and will depend on what data are necessary to demonstrate that a product meets current standards of safety, quality and efficacy.