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Issue With WHO DRUG Dictionary And The ACTIVESUBSTANCE Statement In EMA OOTB Profile (Doc ID 2216588.1)

Last updated on JANUARY 04, 2021

Applies to:

Oracle Argus Interchange - Version 8.1 and later
Information in this document applies to any platform.


Oracle Argus 8.1

Issue with WHO DRUG Dictionary and the ACTIVESUBSATANCE statement.

When a valid WhoDrug has been added to case and correctly encoded, when attempting to generate a draft E2B using out of the box EMA profile, generation fails with warning below:

Error No:402000610 Description Case CASE_NUMBER is missing mandatory information.
The following element is a MANDATORY element and must contain data: ACTIVESUBSTANCENAME.
Stored procedure: GENERATE_SAFETYREPORT See report details.

Steps to reproduce issue


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