Initial E2B(R3) Reports Flagged as Initial Amendment are Auto-rejected by Argus
(Doc ID 2602647.1)
Last updated on FEBRUARY 04, 2021
Applies to:Oracle Argus Interchange - Version 8.1.2 and later
Information in this document applies to any platform.
On Applications Oracle Argus Safety Version : 8.1.2
If an initial E2B(R3) report is flagged as an amendment (field C.1.11.1 = 2), Argus auto-rejects the incoming report with the following reason:
DD-MON-YYYY HH:MM:SS AM DEFAULT : Case not found in the receiver system for Nullification/Amendment Report. SENDER IDENTIFIER = 'ABC' and SAFETYREPORTID = 'SAFETYREPORTID123'
There is already a similar Enhancement Bug 17249950, however this bug is for initial nullifications only (concerning both R2 and R3).
An initial report can be flagged as an amendment based on how the reports in EudraVigilance EVWEB are provided in the download to the Market Authorisation Holders (MAHs). If you download, you get only the newest version of the report that was submitted to Eudravigilance by a third party; EMA does not change the original report.
If only in the amendment report the suspect drug is coded to a product for which your company is MAH, then you will only see the amendment report and that would be the initial version for some customers.
So Argus should ideally not reject it.
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