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.