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Non-receipt of E2B(R3) Acknowledgement from EMA due to missing code in Lab data (Doc ID 2323092.1)

Last updated on MARCH 01, 2021

Applies to:

Oracle Argus Safety - Version 8.1.1 and later
Oracle Argus Interchange - Version 8.1.1 and later
Information in this document applies to any platform.


Argus Safety 8.1.1 successfully completed the recommended E2B(R3) testing with the European Medicines Agency (EMA).

The following issues were observed during the E2B(R3) testing with EMA:

This document provides temporary solutions to the issues until they are provided as a part of the standard Argus product offering.


 Applicable to 8.1.1 R3


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