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null Can serious adverse event reports be submitted to Fimea by e-mail or by fax?

Can serious adverse event reports be submitted to Fimea by e-mail or by fax?

No. Commercial entities are advised to join the European Medicine’s Agency’s EudraVigilance network. It is also recommended for other entities. For information on how to become a member, please visit the Eudravigilance website. Members are required to submit all reports through the website.

Serious unexpected adverse effects that occur in Finland must be reported to the Fimea ADR database (receiver identifier FINAM) and the European Medicines Agency (EMA) (receiver identifier EVCTMPROD).

Serious unexpected adverse effects that occur outwith Finland should be notified to EMA only.

The European Commission has issued detailed guidance on the issue. Please see: ”Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (CT-3)” (PDF).

If you are not a member of the EudraVigilance network, serious adverse events should be reported to Fimea in writing.

10 Nov 2015