Dara Calleary (Mayo, Fianna Fail)
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136. To ask the Minister for Public Expenditure and Reform the requirements his Department has placed on the Department of Health or the Health Service Executive to either notify it or seek its approval for expenditure on a new medicine or medicines; the date from which it has applied; the instances of such requirement being met; the criteria applied by his Department in responding to the Department of Health and or the Health Service Executive; and the policy justification for maintaining such requirement in view of the agreement entered into by the State with an organisation (details supplied). [41924/17]

Paschal Donohoe (Dublin Central, Fine Gael)
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Responsibility for pharmaceuticals is the responsibility for the Minister for Health.

The introduction of new medicines is governed by the Health (Pricing and Supply of Medical Goods) Act 2013 which sets out the responsibilities of the HSE and the Department with regard to this matter.