Vol. 506 No. 2
246 Mr. Stanton asked the Minister for Health and Children the action, if any, he will take to regulate the supply and sale of unlicensed medicines following the intervention of the Irish Medicines Board recently; the further actions, if any, he will take to educate and alert the consumer on bogus claims and for possible health risks; and if he will make a statement on the matter. [15018/99]
The sale or supply of medicinal products is governed by the Medicinal Products (Licensing and Sale) Regulations 1998. These regulations require that all medicinal products placed on the market must be the subject of a product authorisation granted by the Irish Medicines Board, which is the competent authority for the licensing of medicinal products in Ireland. 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.
Under the regulations, powers of enforcement have been given to the board. As the licensing authority, it is appropriate that the board should take primary responsibility for the enforcement of the regulations. In this respect, my Department recently commenced discussions with the board with a view to the establishment of an active enforcement unit within the board.
