Dáil Éireann debate -
Tuesday, 24 Jun 2003

Vol. 569 No. 3

Written Answers. - European Medicines Evaluation Agency.

Denis Naughten

Question:

309 Mr. Naughten asked the Minister for Health and Children the implications of the EU Council decision on regulation of a European Medicines Evaluation Agency; if it will be responsible for the licensing of all pharmaceuticals within the EU; the future role for the Irish Medicines Board; and if he will make a statement on the matter. [17484/03]

Minister for Health and Children (Mr. Martin)

The European Medicines Evaluation Agency is currently responsible for assessing applications for new high technology medicinal products, particularly those resulting from biotechnical processes. Optionally, companies may apply to the agency, for the assessment of medicinal products of significant therapeutic benefit or innovation.

The Health Council recently agreed to extend the scope of the centralised procedure to med icinal products for acquired immune deficiency syndrome, cancer, neurodegenerative disorders and diabetes. At present approximately 200 medicinal products are licensed through the centralised procedure. There are approximately 6,500 products licensed nationally by the Irish Medicines Board. The proposed additions to the list of products for which the E.M.E.A. will be responsible will not have a significant impact on the work of the board. It should be noted that the Board carries out its own assessment of these products and in some instances, acting as rapporteur or co-rapporteur, carries out assessments on behalf of the other member states. In its capacity as the regulatory authority for human and veterinary medicinal products in Ireland, the board continuously monitors the safety of all medicines on the Irish market, regardless of the method of authorisation.