Peter Burke (Longford-Westmeath, Fine Gael)
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452. To ask the Minister for Health if a drug that has recently come on the market in the USA will be available to persons with muscular dystrophy; and if he will make a statement on the matter. [29687/16]

Simon Harris (Wicklow, Fine Gael)
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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 Health Products Regulatory Authority (HPRA) 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 the criteria of safety, quality, efficacy, legal and regulatory requirements.

If the Deputy would identify the medication concerned, my officials can investigate further.