§ The Countess of Marasked Her Majesty's Government:
How frequently their officials inspect manufacturers of organophosphate sheep dips in accordance with Directive 75/319/EEC Article 26.
Earl HoweI assume the noble Countess has in mind Article 34 of Directive 81/851/EEC, which48WA contains an identical provision for veterinary medicines to that in Article 26 of Directive 75/319/EEC, which applies only to human medicines.
The inspection of manufacturers of all veterinary medicines is undertaken by staff of the Medicines Control Agency on behalf of the Veterinary Medicines Directorate. No special arrangements are made for the manufacturers of organophosphorus sheep dips, but the aim is to inspect the premises of all manufacturers of veterinary medicines at least every two years, with more frequent visits when any irregularities are found.
§ The Countess of Marasked Her Majesty's Government:
What were the laws in force in the United Kingdom relating to the requirements of Directive 75(319) EEC, Article 22.1(a).
Earl HoweThe requirements of this article are implemented in UK law by Schedule 2 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (SI 1971 No. 972) as amended by SI 1972 No. 1226 and SI 1977 No. 1053.
§ The Countess of Marasked Her Majesty's Government:
Whether they will categorise all veterinary medicines containing organophosphates as prescription only medicines under Directive 90/676/EEC Article 4.3(b).
Earl HoweWe have no plans to do so. The Veterinary Products Committee have recently advised that organophosphorus sheep dips should continue to be available for the 1993 summer dip, but that the future licensing of these products should be reconsidered at its October 1993 meeting. It would then wish to conclude its current review on the basis of the further data currently being generated. At that time the committee will doubtless consider whether any change in legal category would be justified in the light of the evidence available to it.