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

Last updated on JULY 13, 2023

Applies to:

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

Symptoms

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.

Changes

Applicable to 8.1.1 R3

Cause

	To view full details, sign in with your My Oracle Support account.
	Don't have a My Oracle Support account? Click to get started!

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.

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

Applies to:

Symptoms

Changes

Cause

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!