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EMA R3 Profile - Tag G.k.9.i.2.r.3.EU.1 - Error in Downgrade Report Generation (Doc ID 2446607.1)

Last updated on SEPTEMBER 23, 2021

Applies to:

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


Cases without event reportable / related can not be reported.  Validation for the report fails and report generation also fails.

Value of G.k.9.i.2.r.3.EU.1[EUDRUGRESULT] = 1 should exist for at least one Suspect/Interacting product and at least one of the event reported in the ICSR for cases sent to EVCTM.

The R3 profile has been copied and the conformance rules for EUDRUGRESULT field changed to Optional.


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