Simon Harris (Wicklow, Fine Gael)
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Question 934: To ask the Minister for Health the steps he has taken to implement the European Directive on Traditional Herbal Medicinal Products, 2004/24/EC; the controls exercised by the Irish Medicines Board in this area; the ongoing consultation process that the IMB engages in with suppliers, retailers and users of herbal medicinal products; and if he will make a statement on the matter. [1102/12]

Róisín Shortall (Dublin North West, Labour)
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Directive 2004/24/EC has been implemented into Irish law by the Medicinal Products (Control of Placing on the Market) Regulations, 2007. The Irish Medicines Board (IMB) is the designated competent authority in Ireland for implementation of this legislation. The IMB has established the traditional herbal medicinal products registration scheme, under which applications may be made for granting a certificate of traditional-use registration to herbal medicines. Herbal Medicines must now be manufactured under Good Manufacturing Practice (GMP) to ensure the quality and safety of the product. The IMB is currently engaged in the registration of herbal medicinal products.

An exceptionally long transition period of 7 years, allowing for the registration of traditional herbal medicines already on the market, ended in April 2011. Since 2004, the IMB has published guidance documents for consumers and for the herbal medicines industry, to assist those making applications under the Traditional Herbal Medicinal Products Registration Scheme. The IMB has also held information session s for stakeholders on the requirements for the registration scheme and regularly meets with potential applicants to provide further guidance on the Traditional Herbal Medicinal Products Registration Scheme as required. During 2010, the IMB established a public consultation on herbal substances classification to give greater clarity to the industry as to whether products should be placed on the market as herbal medicinal products or as food supplements.

Simon Harris (Wicklow, Fine Gael)
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Question 935: To ask the Minister for Health the steps he has taken to implement the European Directive on Food Supplements, 2002/46/EC; the effect that this directive has had on the range and variety of vitamin products available to consumers here; and if he will make a statement on the matter. [1103/12]

James Reilly (Dublin North, Fine Gael)
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The Food Supplements Directive 2002/46/EC has been transposed into Irish law by Statutory Instrument No. 506 of 2007, which is implemented by the Health Service Executive, under a Service Contract Agreement with the Food Safety Authority of Ireland (FSAI). The Food Supplements Directive ensures that consumers in Ireland are protected by the harmonised EU rules on the sale of food supplements by setting out a general framework and detailed rules on vitamins and minerals which may be used in food supplements. It also provides the consumer with detailed information on the label to ensure an informed choice can be made.

I am not aware of any effect on the range and variety of products available to consumers in Ireland caused by the implementation of this Directive. It should be noted however, that there is a provision within the Directive for the European Commission to determine maximum and minimum levels of vitamins and minerals in food supplements and this matter remains under consideration at European Commission level.