Mary Coughlan (Donegal South West, Fianna Fail)

Directive 2004/28 of the Council and of the European Parliament, which is the new EU legislation governing the veterinary medicines regime, must be transposed into national law no later than 30 October of this year. My Department has circulated draft regulations designed to give effect to the new EU legislation and to reform aspects of the existing national regime for consultation. Written submissions have been received from most of the stakeholders. My Department has also subsequently met many of these stakeholders as part of the consultative process. In addition, as required by the relevant legislation, the animal remedies consultative committee will meet shortly to consider the draft regulations, following which I will make final decisions on the issues involved so that the regulations can be brought into force by the transposition deadline.

I am aware of the concerns expressed that some veterinary medicines that may currently be purchased from pharmacies will require a veterinary prescription following adoption of these regulations. The position on this issue is as follows. While the directive provides that all veterinary medicines for food producing animals must be subject to prescriptions, it also includes a provision for exemption criteria to be adopted at EU level that will provide a mechanism for certain categories of medicines to be exempted from the prescription requirement. The EU has not yet adopted a decision on the exemption criteria but must do so before 1 January 2007. Pending this decision, existing national prescription and distribution arrangements may remain in place. As I indicated in a previous reply, I will consult on this and make a decision in due course.

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