Suppression of Downgrade and Nullification Reports to European National Competent Authorities in Argus Safety 7.x and 8.x
Last updated on NOVEMBER 13, 2017
Applies to:Oracle Argus Safety - Version 7.0.0 and later
Information in this document applies to any platform.
From 22 Nov 2017, a Marketing Authorization Holder (MAH) will no longer be required to send European domestic post-marketing ICSRs directly to European National Competent Authorities (NCAs); instead they will be submitted to the European Medicinal Agency (EVHUMAN).
The configuration changes in Argus to accomplish this business process change will have the following impact.
- As per current behavior, if an E2B report has been submitted to an Agency through auto scheduling and later if the reporting rules are inactive or changed then the system schedules a downgrade report if there was any significant follow-up received for that Case
- As per current behavior, if an E2B report has been submitted to an Agency and later if the reporting rules are inactive or changed and the case is deleted, a Nullification report will still get scheduled to this Agency and no Nullification report will be scheduled to the EVHUMAN.
This requirement is logged as an enhancement request ER 26867152 - Centralized Reporting to EMA - Workaround for 7x/8x customers.
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