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

Photo of Kate O'ConnellKate 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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