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Update The EMA R3 Profile Conformance Rule To Apply Reporter Country EU (Doc ID 2561695.1)

Last updated on JULY 14, 2020

Applies to:

Oracle Argus Safety - Version 8.2 and later
Microsoft Windows x64 (64-bit)

Symptoms

EMA R3 Profile conformance rule needs to be updated as per guidelines from EMA Regulatory.

The OOB EMA R3 profile in Argus Safety 8.2 checks if the Primary Reporter Country is EU or not, but according to EMA requirements this check should be verified for all reporters regardless of primary reporter type.

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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