§ Mrs. Ray MichieTo ask the Minister of Agriculture, Fisheries and Food what action is being taken in response to the British Veterinary Association recommendations710W concerning a simplified scheme of licensing for medicines used in fish farming; if he will introduce a generic licensing scheme for animal medicines; and if he will make a statement.
§ Mr. MacleanA simplified scheme for the licensing of veterinary medicines in general, not just for fish, where limited claims for use are made, was introduced in February 1990. Two simplified licences have subsequently been granted, one of which was for an antibiotic for use in fish.
Veterinary generics may also be licensed if an applicant can demonstrate bioequivalence to a product which is off patent and has been fully licensed in accordance with directive 81/851 for 10 years. Because the directive did not come into effect until 1983 there are currently no such products, although their number will increase rapidly over the next decade.