Italian states codes enhancement

Summary

Argus to support Italian State codes (Enhancement 32771615)

Description

The EU Individual Case Safety Report (ICSR) Implementation Guide Rev 2 states that for ICSRs with Italy as the Primary Reporter country, REPORTERSTATE [C.2.r.2.5] must be populated with a valid Italian state or province code.

The new ITALIAN_STATES flexible codelist has been added to Flexible Data Re-Categorization to store the Italian states and the corresponding codes.

The EMA E2B(R3) Export and Import mappings have been enhanced to send/receive the Italian states codes for the element REPORTERSTATE [C.2.r.2.5]. A new Conformance rule has been provided for the REPORTERSTATE [C.2.r.2.5] element to check the presence of a valid state name if the Primary Reporter country is Italy.

For more information, refer to the following eTRM documents:

• ArgusInterchange84_E2B (R3) Export Mappings.xlsx
• ArgusInterchange84_E2B (R3) Import Mappings.xlsx
• Argus_Safety8.4_CaseForm_Console_Updates_Summary.xlsx