An EU Directive on criteria for exempting veterinary medicines from a veterinary prescription requirement was adopted by the relevant EU Standing Committee on 10 October. The Commission has indicated that it intends to have the measure published so as to have legal effect before the end of this year. While decisions on the classification of veterinary medicines are ultimately a matter for the Irish Medicines Board, I am satisfied, on the basis of the technical advice to me from my Department, that the criteria, as adopted, mean that current off-prescription veterinary medicines will not have to be reclassified as prescription only.
This is a very positive outcome to this matter from Ireland's perspective and represents a substantial improvement on the draft criteria which were published by the Commission last February. During the intervening period, my Department had made very strong representations to the Commission for a more flexible approach so that decisions on the appropriate classification of veterinary medicines could be taken by regulatory bodies, such as the IMB, based on a scientific evaluation of the risk benefit profile of individual products. I am pleased that the Commission has taken my views into account.