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

Last updated on JULY 13, 2023

Applies to:

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>.

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

• US Marketed License
  
• JP Marketed License 001
  
• JP Marketed License 002
  
  

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

• JP Marketed License 001
  
• JP Marketed License 002

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

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.