G.k.11 has 'TIKEN' in PMDA ICSR R3 for INV License (Doc ID 2408847.1)

Last updated on DECEMBER 16, 2024

Applies to:

Symptoms

PROBLEM DESCRIPTION:
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On a foreign spontaneous case with ICHIHEN Product (a product with both MKT and INV license), PMDA ICSR R3 is scheduled for INV License and G.k.11 has 'TIKEN' text in the generated ICSR.


HOW TO REPEAT:
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1) Create Console objects on Argus Console.
Product-A -- Dosage Formulation = 'Concentrate for solution for infusion'
...|--License-A1 -- US MKT --- hidden link with Product-B
...|--License-A2 -- JP MKT with 'TIKEN' check-box checked --- hidden link with Product-B
...|--License-A3 -- JP INV --- hidden link with Product-B
Product-B -- Dosage Formulation = 'Eye Drops'
...|--License-B1 -- JP INV --- hidden link with Product-A

2) Create a new case by License-A1.
Report Type = Spontaneous
Country = USA
On Case Form >> Products, Case has 1 case product.

3) Enter case data for E2B R3 report.
Case Form >> Analysis >> PMDA Info >> General:
...License-A2 (TIKEN icon is displayed) -- License Category = During early post-marketing phase vigilance, Reporting Category = D
...License-A3
...License-B1 -- License Category = Unapproved, Reporting Category = K

4) On Case Form >> Regulatory Reports, create E2B R3 schedule for License-A2 and License-B1 for PMDA.

5) Click Draft link of report for License-A2 (MKT license).
On ICSR viewer >> Decoded view:
G.k.11 = TIKEN                                 <------------ This is expected.

6) Click Draft link of report for License-B1 (INV license).
On ICSR viewer >> Decoded view:
G.k.11 = TIKEN                                 <------------ This is not expected.

Cause

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