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Incorrect license number displays in PMDA E2B (R3) G.k.3.1 (Doc ID 2483497.1)

Last updated on DECEMBER 29, 2020

Applies to:

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

Symptoms

In the case, several Japan licenses are listed in the case form > analysis > PMDA info tab.

When viewing PMDA E2B (R3), the license# from the different Japan license appears in G.k.3.1 <DRUGAUTHORIZATIONNUMB>.

 


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STEPS
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For example:
Product (A) has the following licenses:

1. Create a foreign case (COI is not Japan) with the US Marketed license from the Product (A)
2. Go to the case form > analysis > PMDA info tab
3. Confirm that following Japan license from the Product (A) are listed


4. Enter the mandatory information for PMDA E2B (R3)
5. Schedule PMDA E2B (R3) with "JP Marketed License 001"
6. Click the draft link of the scheduled report

In G.k.3.1 <DRUGAUTHORIZATIONNUMB>, the license # from "JP Marketed License 002" appears instead of "JP Marketed License 001"

 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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