Brendan Griffin (Kerry South, Fine Gael)
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To ask the Minister for Health when the drug Mabcampath will be licensed for the treatment of multiple sclerosis; and if he will make a statement on the matter. [14374/13]

Alex White (Dublin South, Labour)
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Under European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Irish Medicines Board (IMB) or in the case of certain medicinal products, the European Medicines Agency (EMA). A determination on an application for authorisation of a medicine is based on a rigorous scientific assessment of the application against legal and regulatory requirements.

As the active substance in the product Mabcampath is a genetically modified monoclonal antibody, an authorisation must be granted by the European Medicines Agency, and cannot be granted by a Member State medicines agency such as the Irish Medicines Board. I understand that Mabcampath was authorised by the European Medicines Agency for the treatment of certain forms of leukemia but the authorisation was withdrawn by the manufacturer in August 2012. Mabcampath is not authorised for the use in the treatment of multiple sclerosis.