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Negative Ack Received From EMA Due to CodeSystemVersion as 2.0 for Element N.1.1 (Doc ID 2752875.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.2 and later
Information in this document applies to any platform.

Goal

Currently Argus has generated CodeSystemVersion as 2.0 for Backlog Message Type (N.1.1.CSV) however EMA is expecting Code System Value as 1.0.

Reports sent with N.1.1.CSV value of 2.0 are being rejected by EMA for backlog reports.

Solution

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In this Document
Goal
Solution
References


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