Dáil Éireann Debate, Wednesday - 8 March 2017
29. Deputy James Lawless asked the Minister for Health the number of applications for the addition of a new medicine to the reimbursement list that are being processed as of 1 March 2017; the number of applications in process on the same date in 2015 and 2016; and if he will make a statement on the matter. [12130/17]
View answerThe 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.
