Under the Irish Medicines Board Act, 1995, the Irish Medicines Board is the competent authority for the regulatory control of medicinal products in Ireland. It is not the policy of the Department of Health and Children or the Irish Medicines Board that all health or dietary supplements should be classified as medicinal products.
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. The regulations also contain provisions for a simplified registration procedure for certain homeopathic medicines as required by Council Directive 92/73/EEC relating to homeopathic medicinal products. Before the board 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.