Written answers
Wednesday, 8 March 2017
Department of Health
Medicinal Products Reimbursement
James Lawless (Kildare North, Fianna Fail)
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29. To ask the Minister for Health the number of applications for the addition of a new medicine to the reimbursement list that are currently being processed as of 1 March 2017; the number of applications that were in process on the same date in 2015 and 2016; and if he will make a statement on the matter. [12130/17]
Simon Harris (Wicklow, Fine Gael)
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The HSE has informed me that there were 40 applications for the addition of new chemical entities ongoing as at 1 March 2017. A new chemical entity is a medicine that is not classified as a new generic, new biosimilar or new parallel imported or parallel distributed medicine.
The HSE reports the number of new applications on an annual basis. The HSE has stated that, in 2015 and 2016, there were 63 and 82 applications respectively for new chemical entities. The HSE further advises that 20 to 50 applications would be expected to be ongoing at all times for new medicines and new indications for existing medicines.
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