Finian McGrath
Ceist:437 Deputy Finian McGrath asked the Minister for Health and Children the position regarding a matter (details supplied). [29753/08]
Amharc ar fhreagraWednesday, 24 September 2008
Ceisteanna (358)
Freagraí scríofa
This drug is currently at an early stage of clinical trials in many countries but is not yet licensed in Ireland, any country in Europe or the US. While the initial results are positive later phases of the trials still have to be completed before the efficacy and safety of the product can be fully assessed.
This assessment will then need to satisfy criteria of the Irish Medicines Board (IMB) and the European Medicines Agency (EMEA) which are responsible for the protection and promotion of public health, through the evaluation and supervision of medicines for human use, before they can be put on the Irish or European markets.
The Irish Medicines Board is the statutory body responsible for the regulation of human medicines in Ireland. The Board works closely with both EMEA and other European regulatory bodies on issues of efficacy and safety of medicinal products. As with all medicinal products, the Board will continue to assess new information concerning this drug and liaise with EMEA and the regulatory bodies in other European member states where necessary.
Question No. 438 answered with Question No. 411.