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
Kate O'Connell (Dublin Bay South, Fine Gael) | Oireachtas source
Why was there such a difference between the United Kingdom and Ireland in terms of inclusion in data sheets, as mentioned by Mr. Peter Murphy? That was unusual. Why was there a discrepancy in the information included? As outlined, in 2002 information became available on the summary of product characteristics, SPC, in the United Kingdom but it did not become available here until 2008. Who has responsibility? Does it rest with the HPRA as regards individual member states or the maker - Sanofi?
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