Denis Naughten (Roscommon-South Leitrim, Independent)
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172. To ask the Minister for Health further to Parliamentary Question No. 185 of 3 July 2014, if he will provide an update on the licensing of the drug; and if he will make a statement on the matter. [38821/14]

Kathleen Lynch (Cork North Central, Labour)
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The first step for a medicine to be placed on the Irish market involves the manufacturer seeking an authorisation from the Health Products Regulatory Authority (HPRA) or in the case of certain medicinal products, the European Medicines Agency. A determination on the application for authorisation is based on a rigorous scientific assessment of the application against legal and regulatory requirements.

The HPRA has advised that this medicine was authorised for placing on the Irish market on 5th August last.