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Dáil Éireann debate -
Wednesday, 20 Oct 1999

Vol. 509 No. 5

Written Answers. - Medicinal Products.

John McGuinness

Question:

122 Mr. McGuinness asked the Minister for Health and Children if his Department will examine the statement contained in the document, The Definition of a Medical Product, which states that any product that may be used to prevent cure or alleviate any disease is a medicine in view of the fact that those involved in natural medicine are extremely concerned regarding the statement; his views in this regard; and if he will make a statement on the matter. [20814/99]

Council Directive 65/65/EEC defines a medicinal product as any substance or combination of substances for treating or preventing disease in humans or animals or which may be administered with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions. The directive does not make any distinction between conventional medicines and so-called natural health products or remedies. At the same time it is accepted that there is a range of products on the market which may, depending on circumstances, be classified as either food supplements or medicinal products. For example, certain products such as vitamin or mineral supplements which may sometimes be regarded as food supplements, are sometimes presented at therapeutic dosage levels supported by specific medicinal claims.

Under the Irish Medicines Board Act, 1995, the Irish Medicines Board is the competent authority for the regulatory control of medicinal products in Ireland. The IMB, in its guidelines on the interpretation of the definition of a medicinal product as set out in the Council directive, has revised and updated similar guidelines published by my Department in 1988. The policy in regard to the controls in force in respect of medicinal products (including 'natural' medicinal products) has not changed. If products presented on the market include a medicinal claim, the product concerned is a medicinal product and must be the subject of authorisations under the Medicinal Products (Licensing and Sale) Regulations, 1998, which gives effect to Council Directive 65/65/EEC.

I am aware of concerns expressed regarding the possible application of the guidelines but I would like to assure the Deputy that it is not the intention of the board to in any way interfere with the rights of individuals to avail of those medicines that they may wish to use. It is generally accepted, however, that in the interest of consumer health and protection, some form of regulation of alternative medicines is desirable, and indeed, this is supported, in principle, by the health food and alternative medicines industry. In this respect, the European Commission is currently considering what controls, if any, should be applied to health food products and remedies, including the possibility of providing simplified procedures for the licensing of such products.
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