Dáil Éireann debate -
Tuesday, 5 Feb 2002

Vol. 547 No. 3

Written Answers. - Veterinary Medicines.

Denis Naughten

Question:

188 Mr. Naughten asked the Minister for Agriculture, Food and Rural Development the new regulations he plans to introduce for the administration of animal remedies; the difficulties, if any, he has with the current system; and if he will make a statement on the matter. [3475/02]

Minister for Agriculture, Food and Rural Development (Mr. Walsh)

I intend to bring into effect shortly regulations to transpose into national legislation Directive 2001/82/EC of the European Parliament and of the Council and also Commission Directive 2000/37/EC. The former EU legislation codifies into a single instrument a number of individual EU measures brought into effect over the past 20 years for the purpose of regulating the veterinary medicines sector. Of its nature, such codification does not involve substantive changes in the overall regulatory regime. Commission Directive 2000/37/EC provides for a number of amendments to the pharmacovigilance regime, particularly relating to monitoring adverse reactions, applying to veterinary medicines.

In addition, arising from the recommendation contained in the report to me from the Irish Medicines Board that intramammary antibiotic medicines should be brought under prescription control, my Department is currently considering the legislative changes necessary, bearing in mind that the IMB report recognized that it would not be feasible to apply the current prescription rules in the Animal Remedies Regulations, 1996, to this category of product. In this context my Department has sought the views of interested parties.