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Minister Coughlan welcomes EU Decision on Exemption Criteria for Veterinary Medicines

The Minister for Agriculture and Food, Mary Coughlan TD, has welcomed yesterday's adoption by the EU Veterinary Pharmaceutical Committee of the criteria for exempting certain medicines from the general requirement in EU legislation that all veterinary medicines for food producing animals must be supplied only on the basis of prescriptions.

Minister Coughlan said that, while decisions on the classification of veterinary medicines were ultimately a matter for the Irish Medicines Board (IMB), her Department was satisfied that the exemption criteria mean that current off-prescription veterinary medicines will not have to be reclassified as prescription only.

Commenting on the outcome, Ms Coughlan said that the criteria, as adopted, were a substantial improvement on the draft criteria which were published by the Commission last February. Her Department had made very strong representations to the EU Commission for a more flexible approach to the exemption criteria so that decisions on the appropriate classification of veterinary medicines could be taken by the regulatory authorities, such as the IMB, in each Member State, based on their assessment of the risk/benefit profile of individual products. She said that she was very pleased that her views had prevailed in finalising the criteria.

Minister Coughlan said that the exemption criteria will come into effect on 1 January 2007. As the criteria will not require any current off-prescription medicines to be made prescription only, the Minister said that farmers will continue to get these medicines on the same basis as at present and it will not now be necessary to amend the existing regulations to extend the range of prescribers.

The Minister reminded stakeholders that the veterinary medicines regulations which she signed into law last November included a number of new provisions designed to minimize costs to farmers and to foster competition in the supply of veterinary medicines. These include the removal of the mandatory farm visits by vets prior to writing a prescription, the extension of the life of a prescription from 31 days to six months and the requirement that vets must issue a written prescription and indicate at least two products where a suitable alternative was available. Minister Coughlan also said that, as announced last year and in line with the position obtaining generally throughout the EU, intramammaries will become prescription only medicines from 1 January 2007. Her Department was engaged in consultations with relevant stakeholders in relation to the most appropriate prescribing arrangements for this category of veterinary medicines.

11 October, 2006

NOTE FOR EDITORS

EU Directive 2004/28, which was transposed into Irish law last November, included a provision that all veterinary medicines for food producing animals should only be supplied on the basis of a veterinary prescription, unless exempted from this requirement under criteria to be drawn up at EU level before 1 January 2007. The EU has now adopted the exemption criteria.

Date Released: 11 October 2006