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null An serious unexpected adverse effect is identified in the course of a multi-national research project part of which is carried out in Finland but the adverse effect occurs outwith Finland. Should Fimea be notified?

An serious unexpected adverse effect is identified in the course of a multi-national research project part of which is carried out in Finland but the adverse effect occurs outwith Finland. Should Fimea be notified?

No. All serious unexpected adverse effects occuring outwith Finland should be notified to the European Medicines Agency only.

 

10 Nov 2015