§ Mr. HainTo ask the Secretary of State for Health (1) if he will make a statement on the policy of the Medicines Control Agency in respect of consultation with consumers of dietary supplements prior to the finalisation and publication of the proposed Medicines Act leaflet, MAL 8; and what consultation has so far been undertaken with such consumers and practitioners organisations, with particular reference to the Society for the Promotion of Nutritional Therapy; [40105]
(2) if he will make it his policy to protect the diversity and availability of vitamin, mineral and other dietary supplements currently available to consumers by ensuring that the proposed Medicines Act leaflet, MAL 8, does not impose new regulatory burdens or systems of compulsory pharmaceutical licensing on manufacturers of such products; and what is the extent to which the provisions of MAL 8 will be consistent with the Government's policy of deregulation; [40106]
(3) if he will make a statement indicating the extent to which the provisions of the proposed Medicines Act leaflet, MAL 8, will limit or otherwise affect the sale of dietary supplements currently sold legally; [40107]
(4) if he will make it his policy that in interpreting article 1 of directive 65/65/EEC (a) foods, (b) vitamins, (c) minerals and (d) other products currently lawfully sold as a foodstuff or dietary supplement will not be reclassified as medicinal product by virtue solely of their capacity to restore normality to physiological functions; [40108]
(5) in what circumstances vitamin, mineral and other dietary supplements currently lawfully sold as foodstuffs or dietary supplements will be reclassified as medicinal products requiring pharmaceutical product licences under the provisions of article 1 of directive 65/65/EEC. [40109]
§ Mr. SackvilleMedicines Act leaflet, MAL 8, provides guidance for industry on what is a medicinal product. It has no status in law. The Medicines Control Agency has discussed its proposals for updating it with the Proprietary Association of Great Britain, the British Herbal Manufacturers' Association, the Natural Medicines Manufacturers Association, the Health Foods Manufacturers' Association and the Cosmetic Toiletry and Perfumery Association. The proposals impose no new regulatory burdens on manufacturers of vitamins, minerals, and other dietary supplements currently sold legally.
Products which are food, or which are foods for particular nutritional purposes, are considered under food safety legislation. Products sold as foodstuffs or dietary supplements are not necessarily considered as products to which the Medicines for Human Use (Marketing Authorisations, Etc) Regulations 1994 apply solely because they have the capacity to restore normality to physiological functions. A product currently sold as a foodstuff or dietary supplement would be considered licensable only if, after careful assembly of all the facts of the individual case, it was considered to be a medicinal product to which the Medicines for Human Use (Marketing Authorisations, Etc) Regulations 1994 applied.
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