EMA- Italian Reporter’s State Codes for R3 E2B Reports (Doc ID 2837347.1)

Last updated on JANUARY 06, 2025

Applies to:

Purpose

The purpose of this document is to provide recommendations on the configuration updates required in Argus Safety to support regulations pertaining to Revision 2 of EU R2 ICSR Implementation – Section I.D.5 Reporter’s State codes for Italy.

Scope

This article is applicable to Argus version AS 8.2.3.

For other Versions and customized profiles, please review and add the code logic corresponding to the Italian state codes highlighted.
The available state codes and names are hard coded in the logic and there is no usage of any new tables or code lists.

Note: There is an Enhancement request for the same regulation - BUG 32771615 - ENH: Argus to support for Italian State codes.

This enhancement has been implemented in Argus Safety 8.4.

Please monitor the below note for release details for Argus Safety 8.4 once available:

Oracle Life Sciences Argus Safety Available Patches (Doc ID 1077580.1) 

Details

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