e-transmission of ICSRs to the EMA:
Fallback procedures are outlined below, which apply when mechanical, program, electronic or communication failures occur, and electronic reporting of ICSRs is not possible within the expedited reporting timelines as defined in Community legislation.
The following four scenarios are addressed, which apply to reporting in the pre- and post-authorisation phase:
The scenarios as outlined below are in line with the Note for Guidance on the Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRs) and Medicinal Product Reports (MPRs) in pharmacovigilance during the pre- and post- authorisation phase in the European Economic Area (EEA) . For further details always refer to the guideline. A summary of the steps that should be followed in case of system failure in relation to the electronic exchange of ICSRs with the EMA is provided in the document e-transmission of ICSRs to the EMA: Steps to follow in case of system failure.
Specific templates (Forms) are available here to facilitate the communication during an event of system failure based on the four scenarios outlined above.
The numbering of the Forms is not always consecutive. This is due to additional Forms being used internally by the EMA or in case of additional information requests.