SUSAR reporting

It is the responsibility of the sponsor to ensure that all information pertaining to suspected unexpected serious adverse reactions (SUSARs) due to an investigational medicine in a clinical trial in Iceland are promptly recorded and reported to the Icelandic Medicines Agency (IMA). The timeline for such reporting as follows:

SUSARs

Reporting SUSARs to IMA and the European Medicines Agency´s (EMA) EudraVigilance database

IMA is a so-called webtrader in EV. Sponsors report SUSARs to EMA in EV. IMA has access to information in the database and does not require copies of reports.

If the sponsor does not have access to the EudraVigilance, SUSARs should be reported to IMA on CIOMS forms. IMA will then register the SUSARs into the database.

Guidelines for reporting adverse reactions can be found in

Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (Eudralex – Volume 10, Chapter II: Safety Reporting).