Vol. 506 No. 2
219 Mr. Gormley asked the Minister for Health and Children if his attention has been drawn to the fact that the Irish Medicines Board has announced a major crackdown on vitamins, herbal products and other food supplements and is seeking to have them re-classified as medicines; and if he will make a statement on the matter. [15549/99]
272 Mr. Barrett asked the Minister for Health and Children if his attention has been drawn to an article (details supplied) on 28 May 1999 indicating that the Irish Medicines Board intended to scrutinise certain health products; if this scrutiny will apply to natural medicines such as herbs, essential oils, minerals or vitamins which may be purchased in health food shops; and if he will make a statement on the matter. [15179/99]
I propose to answer Questions Nos. 219 and 272 together.
The Medicinal Products (Licensing and Sale) Regulations, 1998, which give effect to Council Directive 65/65/EEC, require that all medicinal products placed on the market must be the subject of a product authorisation granted by the Irish Medicines Board. Before the board, which is the competent authority for the licensing of medicinal products in Ireland, will grant an authorisation, it must first be satisfied as to the safety, quality and efficacy of the product concerned. In the case of unlicensed products, neither the safety, quality nor efficacy of such products would have been established.
The directive 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. Neither the directive nor the regulations make any distinction between conventional medicines or so-called natural health products. It is, however, accepted that there are 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 may be presented at therapeutic dosage levels supported by specific medicinal claims and, indeed, certain vitamins and minerals can have serious side effects if taken in excessive doses. In this respect, the Irish Medicines Board has recently published guidelines which seek to clarifying the criteria used in classifying such products.
