Oireachtas Joint and Select Committees
Wednesday, 25 April 2018
Joint Oireachtas Committee on Health
Business of Joint Committee
Foetal Anti-Convulsant Syndrome: Discussion
9:00 am
Dr. Almath Spooner:
It is the marketing authorisation holder. Will the Deputy allow my organisation to consider the comparative analysis as it would be remiss of me to respond without having the details in front of me? The general process is the marketing authorisation holder submits a variation to us; we assess it and one anticipates that the company, as a global company, will submit variation to all of the regulatory authorities.
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