Written answers

Tuesday, 16 July 2013

Department of Health

Medicinal Products Availability

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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1038. To ask the Minister for Health his plans to make Selincro/Nalmefene available here; and if he will make a statement on the matter. [34183/13]

Photo of Alex WhiteAlex White (Dublin South, Labour)
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The Health (Pricing and Supply of Medical Goods) Act 2013 was commenced on the 24 June 2013. The HSE is required to assess all new medicines in accordance with the Act and in line with the procedures and timescales agreed last year by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association (IPHA).

The market authorisation holder for Nalmefeme (Selincro) made an application for pricing and reimbursement in June 2013. The HSE has commenced the process of assessment of that application. The HSE has 180 days (with stop clocks) to complete that assessment. A health technology assessment by the National Centre for Pharmacoeconomics will form one of the important inputs into decision making.

It would not be appropriate to comment any further on an ongoing assessment.

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