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Initial PMDA E2B Is Auto Scheduled As Amendment Report (Doc ID 2730334.1)

Last updated on NOVEMBER 23, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.2.1 and later
Information in this document applies to any platform.



The case product has the Japan investigational(INV) license and Japan Marketed(MKT) license.

The case received the follow-up information and set as significant amendment.

When system run the auto-schedule to this case first time, initial report was auto-scheduled for one of the Japan license in the regulatory report tab.

However, in the regulatory report tab, the initial amendment report was auto-scheduled for the other Japan license.

Both should be initial normal reports.




1. Create a new case and set the product which has the Japan MKT / INV licenses
2. In the general tab, add significant amendment follow-up row with the same receipt date as Initial receipt date
3. Enter the mandatory value for PMDA E2B
4. Save the case
5. In the regulatory report tab
6. Press the [Auto schedule] button


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