Non-receipt of E2B(R3) Acknowledgement from EMA due to missing code in Lab data
Last updated on NOVEMBER 28, 2017
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:
- HL7 file had codesystem and codesystemversion attributes without Code which led to non-receipt of Acknowledgements from the EMA’s EudraVigilance test system
- New Unified Code for Units of Measure (UCUM) codes provided in the EMA Implementation Guide rev1 (August 2017) are not included in the Argus 8.1.1 factory data which may result in rejections during E2B Import
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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