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Dáil Éireann debate -
Tuesday, 15 Jun 1999

Vol. 506 No. 2

Written Answers. - Licensing of Medicines.

David Stanton

Question:

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.

In relation to alerting consumers about possible health risks, I would stress the importance of patients and consumers taking the greatest of care in the use of any medicines. Indeed medicines, as such, should normally only be used on the advice of one's doctor or pharmacist as may be appropriate. In addition, it is important that patients should read carefully the labelling and patient information leaflets supplied with their medicines and follow carefully the instructions for their use.
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