§ Mr. MacleanTo ask the Secretary of State for Health what are the nature and scope of the proposed forthcoming recommendations from the European Commission for possible amendments to EU Directive 75/318 relating to herbal remedies; and if he will make a statement. [100252]
§ Ms StuartThe Commission Directive 99/83 EC, adopted in September 1999, amends the Annexe to Directive 75/318 EC. This new Directive provides additional guidance on the data required to meet efficacy and safety requirements where a company seeking marketing authorisation wishes to use bibliographical data for the purposes of establishing that the product has a well established use. We will shortly be bringing forward an amendment to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 to incorporate the change into United Kingdom legislation.
It has become evident recently that there is uncertainty among a number of European Union member states on how to interpret 99/83 EC. We wish to provide stability and certainty for business. Accordingly, the Medicines Control Agency (MCA) is currently raising the issue with the European Medicines Evaluation Agency and the European Commission with a view to achieving greater clarity over interpretation. The MCA will also be discussing this question with our statutory advisory bodies, the Medicines Commission and the Committee on Safety of Medicines.
In on-going discussions in the EU over the interpretation of Directive 99/83 EC, and over the possible creation of an additional category of traditionally used medicines, our objective for herbal remedies will be to achieve proportionate regulatory arrangements, effectively balancing consumer choice and public safety. In working towards this objective, the MCA will continue its programme of informal dialogue with the UK natural health sector.
§ Mr. MacleanTo ask the Secretary of State for Health what plans he has to update the list of specified or toxic herbs which are subject to restrictions on sale and supply set out in the Schedule to the Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977. [100253]
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§ Ms StuartAt Ministers' request, the Medicines Control Agency has considered the need to update the lists of herbs which are subject to restrictions on sale and supply set out in the Schedule to the Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977. The agency believes that the protection of public health will be best served by updating the lists, and work is in progress to that end. Any proposals will be subject to public consultation.