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null A serious unexpected adverse effect is identified as part of research that is not carried out in Finland but is associated with a medicinal substance used in clinical trials in Finland. Should Fimea be notified?

A serious unexpected adverse effect is identified as part of research that is not carried out in Finland but is associated with a medicinal substance used in clinical trials in Finland. Should Fimea be notified?

No. However, the sponsor must notify the researchers and Fimea of significant new information relating to the safety of the investigational medicinal product.

 

10 Nov 2015