Electronic Reporting of Adverse Reactions
All suspected, unexpected and serious adverse reactions (SUSARs) occurring in clinical trials must be reported electronically through the European Medicines Agency EudraVigilance network. Commercial sponsors must register with the EudraVigilance network. Registration is also recommended for non-commercial sponsors. Guidance on registration.
SUSARs occurring in Finland must be reported to the Finnish Medicines Agency, Fimea database (receiver identifier FINAM) and to the European Medicines Agency (receiver identifier EVCTMPROD). SUSARs occurring abroad are reported to the European Medicines Agency only.
Further guidance has been issued by the European Commission: Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use.
Commercial sponsors registered with the EudraVigilance network who are not yet submitting their reports electronically to the Fimea should contact Fimea to commence the usage.
In the case of non-commercial sponsors, which are not registered with the EudraVigilance network, reports to Fimea can continue to be sent in writing. The reports must not be submitted by fax or by e-mail. It can be done by free-form letter or by using the CIOMS-I form or equivalent.
The EMA EudraVigilance Web (EVWeb) testing environment for both Clinical Trial SUSARs (EVCTM) and post-marketing ICSRs (EVPM) will be unavailable from the 5th of September 2016 until the 5th of June 2017. During the downtime, organisations will not be able to perform testing with Fimea.
The production ID for SUSAR reporting must be notified to Fimea before the start of the production phase of reporting.
For further information, please contact:
Technical Support: firstname.lastname@example.org