My Oracle Support Banner

Update Conformance Rules For J2.5.k And J2.6.k (Doc ID 2448722.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Cloud Service - Version 8.0 and later
Information in this document applies to any platform.

Symptoms

During PMDA E2B R3 report generation, below validation errors are displayed
when
-- MHLWSTATUSCATEGORYOFNEWDRUGS (J2.4.k) = '5? (Not applicable)
-- MHLWRISKCATEGORYOFOTCDRUGS (J2.5.k) or MHLWROUTEFORACQUIRINGOTCDRUGS (J2.6.k) has data

(i)  Value for J2.5.k[MHLWRISKCATEGORYOFOTCDRUGS] should not exist for a drug if J2.4k[MHLWSTATUSCATEGORYOFNEWDRUGS] is not 6 or 7
(ii) Value for J2.6.k[MHLWROUTEFORACQUIRINGOTCDRUGS] should not exist for a drug if J2.4k[MHLWSTATUSCATEGORYOFNEWDRUGS] is not 6 or 7

As per regulations it is possible that J2.4.k could be 5 (Not applicable) for intervention required drug and OTC drug (J2.5.k = 6 or 7)

Cause

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!

In this Document
Symptoms
Cause
Solution
References


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