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Dáil

Written answer

Medicinal Products

Summary

The HSE, responsible for pricing and reimbursement decisions, was asked to provide information on approval timelines for rare disease medicines in Ireland and other EU countries.

1178. Deputy Pádraig O'Sullivan asked the Minister for Health the average length of time between European Medicines Agency approval and reimbursement approval in Ireland for rare disease and orphan medicines; and the way in which this compares with other EU countries. [64549/26]

Comment on this

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Comment on this