Reporting adverse reactions electronically

Expedited reporting of post-authorisation ICSRs

In accordance with regulation EC No 726/2004, as of 20 November 2005, electronic reporting is mandatory across the European Economic Area (EEA).

All reports on serious adverse reactions originating from Finland should be sent only to the Finnish Medicines Agency Fimea (not to the European Medicines Agency EMA).

When reporting a Finnish literature case, a copy of the article in question, should be sent by post, fax +358 29 522 3006 or e-mail fimea.ev@fimea.fi to the Pharmacovigilance unit.

Additional information:

Pharmacovigilance unit
Post-authorisation ICSRs: fimea.ev@fimea.fi
Technical Support: e2bsupport@fimea.fi