How should adverse reactions occurred in the clinical trial be notified to Fimea?
Adverse reaction is any untowarded adverse event that may have been caused by the investigational drug product. Serious and unexpected adverse reactions (i.e. SUSARs) must be reported to the authority in an expedited manner. Commercial sponsors are reporting SUSARs electronically via EudraVigilance system.
Sponsors not registered to EudraVigilance (i.e. academic sponsors) should submit their expedited SUSAR reports to Fimea, if SUSAR is originating from Finland. Reports should be sent electronically using Fimea secured email to the address FI-CTA (a) fimea.fi
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