Traditional Medicines Directive

Health written question – answered on 12th February 2002.

Alert me about debates like this

Photo of David Tredinnick David Tredinnick Chair, Statutory Instruments (Joint Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Select Committee), Chair, Statutory Instruments (Joint Committee)

To ask the Secretary of State for Health

(1) what assessment he has made of the impact upon the United Kingdom health products industry of the lack of provision in the proposed Traditional Medicines Directive for products which are combinations of herbs with nutrients;

(2) what legislative provision he plans to propose to secure the continued availability of products which are combinations of nutrients with herbs but which are (a) not foods and (b) unlikely to fall within the provisions of the forthcoming Traditional Medicines Directive;

(3) what recent assessment has been made of how products which are combinations of herbs with nutrients may achieve compliance with the proposed Traditional Medicines Directive.

Photo of Yvette Cooper Yvette Cooper The Parliamentary Under-Secretary of State for Health

holding answer 22 January 2002

Some products containing herbal ingredients and nutrients may currently be sold under food law. Where, however, products containing herbal ingredients and nutrients as active ingredients are classified as medicines, they require a marketing authorisation before being placed on the market. The regulatory position of such products would remain unaffected by the proposals for a directive on traditional herbal medicinal products which have been adopted by the European Commission.

The Commission's proposals for a directive are, as anticipated, restricted to traditional herbal medicines. Mixtures of herbal and other active ingredients would therefore fall outside the scope of the directive. We will need to give consideration to the criteria for determining the circumstances in which ingredients would be regarded as active.

The proposed directive contains provision for a later review which would consider the possibility of extending traditional use registrations to other categories of medicinal products. Our current assessment is that an extension of the proposed system for traditional use registrations to other categories of traditionally used medicines would be insufficient to cover a significant proportion of herbal and nutrient combination products. It would require an additional change in European legislation to permit on the market those herbal and nutrient combination products classified as medicines for which neither evidence of traditional use nor efficacy, as required for a marketing authorisation, could be demonstrated. Our current priority remains to secure an effective regulatory regime for traditional herbal remedies.

Does this answer the above question?

Yes1 person thinks so

No0 people think not

Would you like to ask a question like this yourself? Use our Freedom of Information site.