Dáil Éireann debate -
Thursday, 26 May 1994

Vol. 443 No. 3

Written Answers. - National Drugs Advisory Council.

Paul Connaughton

Question:

76 Mr. Connaughton asked the Minister for Health whether it is intended to have representatives from the Irish Association of Medical Herbalists on the National Drugs Advisory Council; and if he will make a statement on the matter.

Paul Connaughton

Question:

100 Mr. Connaughton asked the Minister for Health whether he intends to refer herbal remedies to the National Drugs Advisory Council; and if he will make a statement on the matter.

Minister for Health (Mr. Howlin)

I propose to reply to Questions Nos. 76 and 100 together.

The controls governing the licensing, advertisement and sale of medical preparations are set out in the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984-1993.

Herbal preparations may, in certain circumstances, be classified as medical preparations within the terms of the regulations. Products containing herbal ingredients are considered to be medical preparations when (a) the labelling or accompanying or associated literature makes any preventative, curative or remedial claim, or (b) any of the herbal ingredients presented is recognised as having medicinal properties.

Where such product is deemed to be a medical preparation it would be required to be the subject of a product authorisation as required by the regulations. All applications for product authorisations are assessed on my behalf by the National Drugs Advisory Board to establish the safety, efficacy and quality of the product.

Comprehensive guidelines on the classification of borderline products, including those containing herbal ingredients, have been published by my Department and any such product which is deemed to be a medical preparation is required to be the subject of a product authorisation as required by the regulations.

It is not my intention at this time to appoint a representative of the Irish Association of Medical Herbalists to the National Drugs Advisory Board.