EudraVigilance - Electronic reporting

IMCA has posted letters on the EudraVigilance website on how to report electronically.

IMCA is a Webtrader in the EudraVigilance system and is thus E2B compliant.

Marketing authorisation holders are required to send all serious ICSRs of cases occurring in Iceland electronically to both EudraVigilance with the message receiver identifier EVHUMAN and to the IMCA with the message receiver identifier ADALIMCA01.

When a local representative of a MAH in Iceland receives a report directly from a healthcare professional, in addition to submitting it to the MAH, the report should also be sent to  IMCA.

Third country (non-EEA) suspected unexpected serious adverse reactions should be sent to EudraVigilance only, with the message receiver identifier EVHUMAN.

Please also note that MAHs, which are not yet able to report electronically, must perform paper-based reporting to the IMCA until they have successfully implemented electronic reporting to EudraVigilance.

Once a MAH has completed a testphase with  EMEA a testphase is not required to be completed with the IMCA.