Róisín Shortall (Dublin North West, Independent)
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To ask the Minister for Health the position in relation to the approval of the drug ampligen as a reimbursable drug under the GMS in Ireland [7975/13]

Alex White (Dublin South, Labour)
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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). In the case of Ampligen, because of the biotechnology nature of the active substance involved, any application for Ampligen to be made available to European patients has to be made to the EMA. I have no information on whether or not such an application has been received by the EMA. The current position, therefore, is that Ampligen has not been authorised to be placed on the market in Europe and consequently does not meet the criteria for reimbursement under the GMS and community drug schemes.