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Non-Japanese license name displays in PMDA E2B (R3) paper report (Doc ID 2492445.1)

Last updated on FEBRUARY 11, 2019

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

When printing PMDA E2B (R3) paper report to Japan MKT license from the foreign case, non-Japanese license name displays in the “販売名 / 治験成分記号” column.

 

Sample Scenario:

PRODUCT (A) has the following 2 licenses

Steps:
1. Create a new case with COI is USA and select US license "US-MKT-001"
2. Set the mandatory information for PMDA E2B (R3)
3. Schedule PMDA E2B (R3) to the Japan license "JP-MKT-001"
4. Click the draft link and view the PMDA paper report
5. In the “販売名 / 治験成分記号” column, US license name "US-MKT-001" in the case product tab displays. Instead, Japanese trade name for Japan license "JP-MKT-001" displays here.




Cause

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In this Document
Symptoms
Cause
Solution
References


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