SUSARs
It is the responsibility of the sponsor to ensure that all information pertaining to suspected unexpected serious adverse reactions due to an investigational medicine in a clinical trial in Iceland are promptly recorded and reported to IMCA. The timeline for such reporting is here below
Reporting SUSARs to the Icelandic Medicines Control Agency (IMCA) and the EudraVigilance database of the European Medicines Agency (EMEA)
The sponsor shall report SUSARs to IMCA. IMCA only wishes to receive reports of SUSARs occurring in Iceland.
IMCA is a so-called webtrader in the EudraVigilance database of EMEA. IMCA requests sponsors which are registered users of the database to choose IMCA (ADALIMCA01) as a recipient of the report along with EMEA (EVHUMAN) for adverse reactions occurring in Iceland.
If the sponsor does not have access to the European database EudraVigilance, IMCA will report the SUSARs into the database.
SUSARs shall be reported to IMCA on a CIOMS form.
IMCA has to date published two letters on the EudraVigilance homepage with information to MAHs and sponsors of clinical trials on how to report adverse reactions to IMCA
A sponsor which is a registered user of the EudraVigilance database and has finalised a testphase at EMEA does not need to finalise a testphase at IMCA, but can report adverse reactions occurring in Iceland directly to the database and choose IMCA and EMEA as recipients of the report.
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 10).
Guidelines for the European database EudraVigilance can be found in
Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudralex 10)
Reporting SUSARs from countries outside the European Economic Area (EEA)
The sponsor shall report SUSARs from countries outside EEA if the same clinical trial is also conducted within EEA.
IMCA has access to adverse reactions (SUSARs) occurring outside Iceland through the EudraVigilance database.
SUSARs from countries outside EEA shall be reported in an identical manner to other ones into the European database EudraVigilance.
Serious adverse events (SAE)
The investigator shall forthwith inform the sponsor about all serious adverse events, which are not described in the protocol, in the investigator’s brochure and/or in the Summary of Product Characteristics (SPC).
If the serious adverse event is death the investigator must inform both IMCA and the sponsor.
