Denis Naughten (Longford-Roscommon, Fine Gael)
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Question 437: To ask the Minister for Agriculture and Food further to Parliamentary Question No. 178 of 17 October 2006, the procedure for including new products on the exemption list from 1 January 2007; if reformulated products, currently forming part of the exemption list, will be exempted or if they will be required to go through an approval process; and if she will make a statement on the matter. [36378/06]

Mary Coughlan (Donegal South West, Fianna Fail)
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The EU Directive providing for exemptions from the mandatory veterinary prescription requirement was adopted by the Standing Committee for Medicinal Products for Veterinary Use on 10 October last. The Directive concerned does not specify a list of products to be exempted, but rather contains a set of criteria on the basis of which Member States, if they choose to do so, may exempt products from the prescription requirement. As the Irish Medicines Board is designated under national legislation as the competent authority, it will be a matter for that body to apply the criteria in individual cases. As I have already informed the House, I am satisfied that the criteria, as adopted, will not require 'off prescription' veterinary medicines to be reclassified.

The Directive concerned requires each Member State which decides to avail of the exemptions provision to notify the EU Commission by 31 March 2007. My Department will send the appropriate notification to the Commission before this deadline. While it is ultimately a matter for the IMB, it is not envisaged that existing 'off-prescription' products will have to go through a formal approval process arising from the criteria. In terms of reformulated products, it is understood from IMB that such products, in the normal course, must go through the appropriate approval process specified by the Board. In any event, as part of its statutory functions, IMB is required to keep the risk benefit profile of all products under ongoing review in light, for example, of advances in scientific knowledge, data supplied by sponsoring companies and safety information supplied by users.