Brexit Impact on Argus Safety
(Doc ID 2737515.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Interchange - Version 8.1.2 and laterOracle Life Sciences Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.
Revision History:
08-Jan-2021:
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.
11-Jan-2021:
For Custom EMA R2 Profile
• Included import mappings for PRIMARYSOURCECOUNTRY
• Removed import mappings RECEIVERCOUNTRYCODE and SENDERCOUNTRYCODE
• Allowed values update is included for PRIMARYSOURCECOUNTRY
For Custom EMA R3 Profile:
• Removed import mappings for SENDERCOUNTRYCODE and STUDYREGCOUNTRY
22-Jan-2021:
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
03-Feb-2021:
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
Goal
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:
- Questions and answers to Stakeholders on the implementation of the Protocol on Ireland/Northern Ireland
- Notice to Stakeholders Withdrawal of the United Kingdom and EU Rules for Medicinal Products for Human Use and Veterinary Medicinal Products
- Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralized procedure
- MHRA updated guidance on pharmacovigilance procedures
This requirement is logged as an enhancement request Bug 31974719 - Addition of New Country Code For Northern Ireland.
Solution
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In this Document
| Goal |
| Solution |
| References |