§ Mr. MitchellTo ask the Secretary of State for Health what plans he has to issue further guidance to the Medicines Control Agency about the classification of products containing blends of herbal, vitamin and mineral 179W supplements; and if it is his policy that dietary supplements should be available on general retail sale provided that they are safe. [58731]
§ Ms JowellThe Medicines Control Agency acts on behalf of the Licensing Authority in accordance with Medicines Act 1968. The Agency classifies products on a case by case basis in accordance with European Community and United Kingdom law, legal precedent and published guidance, and there are no plans to change this. Whether a product is subject to food or medicine legislation is a matter of law not policy. Products which are not medicinal products and fall within the definition of food must comply with the law relating to food. Amongst other things, this effectively requires that products are safe.
§ Mr. MitchellTo ask the Secretary of State for Health if a product containing a blend of herbal, vitamin and mineral supplements may require a medicine's product licence in cases where different elements of that blend could each be sold separately without such a licence. [58536]
§ Ms JowellA product containing a blend of herbs, vitamins and minerals whose different elements could be sold separately under food law is not considered a medicinal product by the Medicines Control Agency, unless it is presented for treating or preventing disease or it may be administered with a view to restoring, correcting or modifying physiological functions in humans. However, where a herbal product—whether or not it includes non-herbal substances—is classified as a medicinal product it will be subject to medicines legislation. Herbal remedies, accordingly, require a marketing authorisation (product licence) unless they are exempt from licensing under the terms of Section 12 of the Medicines Act 1968. Section 132 of the Act makes it clear that the exemption for herbal remedies does not extend to products which contain active non-herbal substances.
§ Mr. MitchellTo ask the Secretary of State for Health what criteria are used by the Medicines Control Agency in classifying a blend of herbal, vitamin and mineral supplements as a medicine; whether the criteria include the availability of the product on general retail sale in other states in the European Union; and if it is the practice of the Agency to provide manufacturers of such blends with a statement of the reasons for so classifying a product. [58537]
§ Ms JowellIn assessing whether a product is a medicine, the Medicines Control Agency (MCA) has regard to the definition of a medicinal product found in Pharmaceutical Directive 65/65/EEC. It also has regard to legal precedent, and its guidance, (including assessment criteria), which it has published in its leaflet Medicines Act Leaflet 8: "A guide to what is a medicinal product". On a case by case basis, the MCA decides whether a product is presented for treating or preventing disease, or may be administered with a view to restoring, correcting or modifying physiological functions in humans. If either or both, the product is a medicine. The MCA does regard a product's status in other member states as a relevant factor when coming to a decision on its classification in the United Kingdom.
When notifying a manufacturer that it has classified a product as a medicinal product, the MCA explains the grounds for its decision.