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Incorrect A.1.13.1 (Reason For Nullification) Is Generated In Nullification For Non-PMDA E2B (Doc ID 2346999.1)

Last updated on FEBRUARY 01, 2021

Applies to:

Oracle Argus Safety - Version 7.0.7 and later
Information in this document applies to any platform.


When a Nullification for Non-PMDA E2B is scheduled after case product is changed, the A.1.13.1 (Reason for nullification) is generated as case product change justification instead of nullification justification.


Steps to repeat:

1) Log in to Argus Safety application by E user, create a new case and enter data to the case for E2B.

2) Schedule an Initial E2B to Non-PMDA agency. Confirm E2B can be generated by Draft link of the E2B schedule.

3) Lock the case and generate Initial E2B.

4) Transmit the Initial E2B.

5) Import ACK and submit the Initial E2B.

6) Unlock the case as Significant Follow-up.

7) Change Case Product on Case Form >> Products by [Select] button. Enter Justification "PRODUCT CHANGE JUSTIFICATION".

8) Schedule Nullification for the Initial E2B. Enter Justification "X-PRODUCT NULLIFICATION JUSTIFICATION".

9) Click Draft link of F/U#1 Nullification on Case Form >> Regulatory Reports.

---> A.1.13.1 is generated by product change justification texts.





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