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How to Handle the ICSR Validation for the MFDS Profile : G.k.3.1 License Number Should Always be Transmitted Along With G.k.3.2 Country (Doc ID 2884564.1)

Last updated on AUGUST 24, 2022

Applies to:

Oracle Argus Safety - Version 8.2.3.1 and later
Information in this document applies to any platform.

Goal

As per the oracle document (Doc ID 2745453.1), the below ICSR validation was observed while testing the Argus 8.2.3 with MFDS.
The system does not allow to generate MFDS report if the license Authorization number is left blank.
This requirement holds true for post marketing cases submitted to Korea, but license number will not be provided by MFDS for investigational product. So the current functionality triggers the below validation irrespective of Investigational or Marketed License.

Validation message:
G.k.3.1 license number should always be transmitted along with G.k.3.2 Country
 

Solution

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In this Document
Goal
Solution
References


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