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Medicines And Healthcare Products Regulatory Agency

Volume 410: debated on Monday 18 August 2003

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To ask the Secretary of State for Health if he will make a statement on the role of the Medicines and Healthcare Products Regulatory Agency in negotiations with the European Commission on the proposed Traditional Herbal Medicinal Products Directive. [128312]

The Medicines and Healthcare products Regulatory Agency (MHRA) and, before April 2003, the Medicines Control Agency (MCA) represented the UK Government in the negotiations on the proposed Directive on Traditional Herbal Medicinal Products that have taken place in the Council of Ministers Working Group in 2002 and 2003 under the chairmanship of successive European Union Presidencies. Before the publication in 2002 of the European Commission's formal proposals for a Directive the MCA had a range of discussions with the European Commission and representatives of other Member States, predominantly in the European Pharmaceutical Committee and an expert group set up by that Committee, about the emerging proposals.During this period the MCA and later the MHRA has held discussions on a number of occasions with the UK herbal sector about issues and priorities to be pursued in the negotiations, notably the case for flexibility to take greater account of evidence of traditional use from outside the EU and to permit vitamins and minerals to be added to traditional herbal remedies registered under the proposed Directive.