Medicinal Products Licensing

Dáil Éireann Debate, Wednesday - 15 May 2019

Wednesday, 15 May 2019

Questions (163)

Louise O'Reilly

Question:

163. Deputy Louise O'Reilly asked the Minister for Health the clinical trials conducted on sodium valproate here prior to its licensing in 1975; and if no clinical trials were conducted here, the international clinical trial data used as the basis for its approval. [20976/19]

Written answers

Minister for Health

The Health Products Regulatory Authority (HPRA) has advised my Department that it will take some time to compile the information requested by the Deputy. Therefore, I have asked the HPRA to reply directly to the Deputy on this occasion.