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

Changes to the ICSR submissions in the new Eudravigilance system

Published 7.6.2017, updated 16.10.2017

According to European Medicines Agency (EMA) announcement, the enhanced EudraVigilance system will be launched on 22nd November 2017, and the simplified reporting procedure for postmarketing individual case safety reports (ICSRs) through EudraVigilance will be applicable from that date.

The Finnish Medicines Agency Fimea is following the timelines set by EMA, and is not imposing additional national requirements. Thus from 22nd November 2017 Fimea will only submit ICSRs to EMA, and they will be submitted in one of the national languages. Fimea will thereafter no longer forward ICSRs to marketing authorization holders (MAHs).

Reporting of adverse reactions in clinical trials:
http://www.fimea.fi/web/en/supervision/clinical_drug_trials/electronic_reporting_of_adverse_reactions

Any questions related to the ICSR reporting from MAHs to EMA should be directed to EMA.

Further questions related to Fimea: FIMEA.EV@fimea.fi