e-transmission of ICSRs to the EMA:
Steps to follow in case of system failure
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:
- Failure of ICH M2 safety or acknowledgement messages transmission at the Sender's gateway
- Failure of generation of ICH M2 safety or acknowledgement messages at the Sender's database
- Failure of ICH M2 safety or acknowledgement message receipt in the event of a prolonged non-availability of the EudraVigilance Gateway at the level of the EMA
- Failure of EVWEB at the level of the EMA
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 addressee and address for physical media deliveries are specified in the relevant Form(s).
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.
In case of a system failure that affects your expedited e-reporting of ICSRs to one or more National Competent Authorities, please ensure that the Authorities are also informed accordingly in line with the procedures outlined below.
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Last update: Wednesday, 6 July 2016.