Denis Naughten (Longford-Roscommon, Fine Gael)
Link to this: Individually | In context

Question 274: To ask the Minister for Agriculture and Food the status of the animal remedies regulations; the discussions to date with the EU on the issue; and if she will make a statement on the matter. [30262/06]

Denis Naughten (Longford-Roscommon, Fine Gael)
Link to this: Individually | In context

Question 275: To ask the Minister for Agriculture and Food the status of the implementation of the animal medicines regulations; and if she will make a statement on the matter. [30263/06]

Mary Coughlan (Donegal South West, Fianna Fail)
Link to this: Individually | In context

I propose to take Questions Nos. 274 and 275 together.

The Animal Remedies Regulations 2005, which came into effect in November 2005, transposed into Irish legislation EU Directive 2004/28. This Directive includes a general requirement that all medicines for food-producing animals may only be supplied on the basis of a veterinary prescription from 1 January 2007, unless exempted from this requirement under criteria to be adopted at EU level.

The Commission has recently circulated its formal proposals for exemption criteria and these are due to be considered by Member States at a meeting of the relevant standing committee on 11 October. While the proposals are still being considered in detail within my Department and in the Irish Medicines Board, it is clear that, on the basis of an initial examination, the latest proposals represent a considerable improvement over the Commission's initial draft published in February last in that they provide a much greater degree of flexibility to regulatory bodies, such as IMB, in determining the routes of supply for individual products based on scientific evaluation of the risk/benefit analysis.

The objective of my Department continues to be to secure exemption criteria which will facilitate the retention of off-prescription status in Ireland for the existing range of products and hopefully this issue will be finally resolved on 11 October. As I have indicated in the past, if the exemption criteria adopted by the EU necessitate the re-classification of veterinary medicines as prescription only products, I will make provision for suitable persons to prescribe the new prescription-only products.