Enable PMDA Due Dates Based on Localized Case Assessments

Learn how to configure your Vault to calculate due dates based on the Localized Case when reporting to the PMDA.

Last Updated Dec 6, 2023

Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

About the Feature

In 23R2, Vault Safety introduced PMDA Local Assessments and Expectedness as part of the PMDA Local Case Processing Automations feature, with the plan to update the associated Reporting Rules in a later release. In 23R3, the PMDA Reporting Rules can run on and calculate due dates for each Localized Case Assessment on a Localized Case for Japan. You control whether Localized Due Dates are calculated based on the Global Case New Info Date or the Localized Case Local Awareness Date.

Before configuring this feature, ensure you have enabled PMDA Local Case Processing Automations.

After configuring this feature, see Set Up the Localized Business Admin Library: Set Up Localizations and Prepare a Localized Case: Evaluate Reporting Obligations for Localized Case Assessments for more information.

Add the Localized Due Date Calculation field to the Localization Object

Complete the following steps to add the Localized Due Date Calculation field to the Localization object:

1. Go to Admin > Configuration > Objects > Localization > Page Layouts > Localization Detail Page Layout.
2. In the Details section, add the Localized Due Date Calculation field.
3. Select Save.

Configure the Localized Due Date Calculation for Japan

Complete the following steps to set the Localized Due Date Calculation field for Localized Cases that are reportable to the PMDA:

1. Go to Business Admin > Objects > Localizations > Japanese (Japan).
2. Select Edit.
3. In the Assessment Generation field, ensure that Localized Case Assessment for Case Product Registration is selected.
4. In the Localized Due Date Calculation field, select from the following options:
   • Global Case - New Info Date
   • Localized Case - Local Awareness Date
5. Select Save.

Add Due Date Fields to Localized Case Assessments

Complete the following steps to add the Due Date and Due in Days fields to the Localized Case Assessment object:

1. Go to Admin > Configuration > Objects > Localized Case Assessment > Page Layouts > Localized Case Assessment Detail Page Layout.
2. In the Details section, add the following fields:
   • Due Date
   • Due in Days
3. Select Save.

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