Medicines Directive (Hansard, 20 December 2000)

§ Mr. Todd
To ask the Secretary of State for Health what progress the Medicines Control Agency has made in promoting, within Europe, its proposals for a Traditional Use Medicines Directive; and what the main provisions are of its proposals. [143447]

§ Ms Stuart
At the European Pharmaceutical Committee in September member states agreed the case for a directive on traditional medicinal products. The European Commission subsequently circulated a preliminary draft to member states in order to assess the range of views about possible specific provisions. The proposals draw from work carried out by an expert working group of the Committee for which the Medicines Control Agency (MCA) acted as rapporteur. We will place copies of the text in the Library. The MCA has recently held discussions with representatives of herbal interest groups to discuss our response to the Commission's proposals.

§ Mr. Todd
To ask the Secretary of State for Health if he will make a statement on the extent to which the proposed Traditional Use Medicines Directive will provide a secure legal basis for products which are(a) combinations of herbal and other ingredients for which 30 years safe traditional use can be demonstrated and (b) combinations of herbal and other ingredients which have been brought more recently to market. [143430]
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§ Ms Stuart
Many products consisting of combinations of herbal and other ingredients can currently be sold legally, for example under food or cosmetic law, and we anticipate that this will continue to be the case. Where, however, such combination products are classified as medicines they require a marketing authorisation before they can be placed on the market.
At this very early stage in discussions on the European Commission's proposals for a directive on traditional medicinal products it is not yet clear whether coverage would be restricted to traditional herbal medicines or whether in some circumstances traditional medicines containing other ingredients could also be permitted under the terms of the directive.

§ Mr. Todd
To ask the Secretary of State for Health if he will make a statement on the extent to which the proposed Traditional Use Medicines Directive will provide a secure legal basis for products which are herbal medicines exempt from licensing under section 12 of the Medicines Act 1968. [143446]

§ Ms Stuart
If the proposals for a directive on traditional medicinal products can be agreed, we expect that it would provide a secure legal basis for regulating a wide range of traditional herbal remedies of the kind currently sold to the public under section 12(2) of the Medicines Act 1968. It is unlikely that the directive would have a direct impact on arrangements whereby herbalists make up and supply the public with herbal remedies following face to face consultation, as permitted under section 12(1) of the Act.