Required Changes in Argus Safety for the European Medicines Agency (EMA) Message and ACK DTD URLs Change
(Doc ID 3068048.1)
Last updated on MARCH 03, 2025
Applies to:
Oracle Life Sciences Argus Safety - Version 8.4 and laterOracle Life Sciences Argus Safety Japan - Version 8.4 and later
Oracle Life Sciences Argus Interchange - Version 8.4 and later
Oracle Life Sciences Argus Safety Cloud Service - Version 8.4 and later
Oracle Life Sciences Argus Interchange Cloud Service - Version 8.4 and later
Information in this document applies to any platform.
Symptoms
Note: The below applies to any Agency or Authority utilizing the EMA / Eudravigilance Document Type Definition( DTD) URLs
E2B reports and acknowledgments cannot be created or imported for destinations utilizing the Eudravigilance Document Type Definition (DTD) URL.
This applies to any reporting destination that is configured in Argus Console to reference Eudravigilance URLs for the Message DTD and ACK DTD.
1. Argus Interchange is writing the following errors in the ESM E2b and ACK Transmission Log files when creating XML files for the E2b reports and Acknowledgments transmitted utilizing Eudravigilance URLs:
Cause
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In this Document
| Symptoms |
| Cause |
| Solution |