Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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Question 212: To ask the Minister for Health and Children if the Traditional Herbal Medicinal Products Directive 2004/24/EC has been fully transposed into Irish law and if all provisions arising from the measure or measures through which it was transposed have come into effect; if not, the timeline for same; and if she will make a statement on the matter. [27856/10]

Mary Harney (Dublin Mid West, Independent)
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Directive 2004/24/EC has been fully transposed into Irish law in the Medicinal Products (Control of Placing on the Market) Regulations 2007, the Medicinal Products (Control of Manufacture) Regulations 2007, the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 and the Medicinal Products (Control of Advertising) Regulations 2007. The Irish Medicines Board (IMB) has put in place a scheme which meets the provisions of the Directive – details were set out in the Guide to Traditional Herbal Medicinal Products Registration Scheme, September 2007.

Under the Medicinal Products (Control of Placing on the Market) Regulations, 2007, all medicinal products on the market must have either a marketing authorisation or a certificate of registration. As provided for in Directive 2004/24/EC, the Regulations provide an exemption from this requirement until 30 April 2011 for traditional herbal medicinal products that were on the market in the State on the coming into force of the regulations (20 July 2007). The IMB has issued guidance to companies in relation to the ending of this transitional period in its most recent newsletter.