Dáil Éireann Debate, Wednesday - 29 September 2004
797 Mr. Naughten asked the Minister for Health and Children when the National Drugs Advisory Board first informed his Department of the fact that growth hormone from pituitary glands administered here was sourced from Irish hospitals; and if he will make a statement on the matter. [21669/04]
View answerThe National Drugs Advisory Board was the statutory body which assessed proprietary medicinal products for suitability for human use until the Irish Medicines Board was established on 1 January 1996. The board assessed the technical data about a particular product and if it considered that a product authorisation should issue, it made a recommendation to that effect to my Department which issued product authorisations on behalf of the Minister.
Under the procedures then in place, the documentation that the board furnished to the Department was an extract from the product authorisation application that contained certain administrative information relating to the product. In the case of medicinal products for the treatment of growth disorders, the documentation furnished to the Department would not have indicated the source of the hormone concerned, whether by country or otherwise.
