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Brexit Impact on Argus Safety (Doc ID 2737515.1)

Last updated on MARCH 23, 2021

Applies to:

Oracle Argus Interchange - Version 8.1.2 and later
Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.
Revision History:

To enable seamless upgrade, the country code list updates for Northern Ireland should be done with Country_id =283. Post Country Code list updates, details of the steps to clear cache are provided.
Sample export SQLs to support custom EMA R2 and EMA R3 profiles for Report Country are provided for reference.

For Custom EMA R2 Profile
• Included import mappings for PRIMARYSOURCECOUNTRY
• Allowed values update is included for PRIMARYSOURCECOUNTRY
For Custom EMA R3 Profile:
• Removed import mappings for SENDERCOUNTRYCODE and STUDYREGCOUNTRY

Section 7: Added additional point to update the Submitted date to 1-1-1900 via backend
Section 8.1:
Renamed and Provided additional sample export sql for OCCURCOUNTRY and PRIMARYSOURCECOUNTRY-EMA_R2_EXPORT.sql
Provided sample import SQLs for REPORTERCOUNTRY and OCCURCOUNTRY - EMA_R2_IMPORT.sql
Section 8.2:
Renamed sample export SQLs for REPORTERCOUNTRYR3 –EMA_R3_EXPORT.sql
Provided sample import SQLs for REPORTERCOUNTRYR3 and RECEIVEDATER3 – EMA_R3_IMPORT.sql
Updated Section 8.3- Optional Steps for Exporting/Importing ‘XI’ in Other Country Elements
Updated Section 9- DSUR to MHRA would be in accordance with ICH-E2F Guidelines

Additional steps added for setting the follow up number in dummy records creation
Mapping Updates – Note added clarifying that the sample scripts are based on AS 8.2.2


This note provides recommendations for the configuration updates required in Argus Safety to support regulations pertaining to ICSR submissions to EVPM, EVCTM and MHRA from 1-Jan-2021 due to Brexit and the Northern Ireland Protocol.

These recommendations are based on the following regulations:

This requirement is logged as an enhancement request Bug 31974719 - Addition of New Country Code For Northern Ireland.


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