Adverse reaction reporting (EudraVigilance)

The European Medicines Agency's (EMA) current EudraVigilance database has been fully operational since 22 November 2017. In accordance with the section 30 f (1258/2021) of the Medicines Act (395/1987) the marketing authorisation holder, parallel import authorisation holder and registration holder shall report not only all serious suspected adverse drug reactions but from the European Union also the non-serious suspected adverse drug reactions that reach their attention, electronically as individual case safety reports (ICSRs) to the EudraVigilance database. Fimea has access to EudraVigilance data and records Finnish ICSRs from the EudraVigilance database in Fimea’s national adverse reaction register.

How marketing authorisation holders submit ICSRs to the EudraVigilance database (post-authorisation module, EVPM)?

Additional information can be found on the websites EudraVigilance (EMA) and Frequently asked questions about reporting adverse drug reactions (ADRs). Any questions related to ICSR traffic between marketing authorisation holders and EMA should be directed to EMA. Questions related to Fimea can be sent to [email protected]. In case secure mail is required, Fimea’s secure mail should be used: More information about Fimea’s secure mail.

Instructions on safety reporting in clinical trials: Safety reporting in clinical trials

Instructions for public on reporting adverse reactions: Submitting a report on an adverse reaction