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.