ICSR reporting to the EudraVigilance system

Expedited reporting of post-authorisation ICSRs

The European Medicine Agency's new EudraVigilance database has been fully functional since 22 November 2017. In accordance with the provisions on pharmacovigilance in Regulation (EC) 726/2004 on medicinal products for human and veterinary use and Directive 2001/83/EC on medicinal products for human use this results in changes in the reporting of suspected adverse reactions.

The main change in the reporting of suspected adverse reactions relates to the obligation of the marketing authorisation holder, parallel import authorisation holder and registration holder to report also non-serious suspected adverse reactions encountered in the European Union electronically as individual case safety reports (ICSR) to the EudraVigilance database. The other changes relate to the ICSR traffic, with marketing authorisation holder, parallel import authorisation holder and registration holder reporting all the suspected adverse reactions reports that reach their attention directly to the EudraVigilance database, and not to Fimea.

See also: The new EudraVigilance system: Fimea's questions  and answers

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

Reporting of adverse reactions in clinical trials