Learn how to configure your Vault to export Substance codes based on JDrug codes to PMDA E2B(R3) reports.
About the Feature
With the 24R2 release, Vault Safety improves the export of Substance codes to PMDA E2B(R3) reports. For Domestic and Localized Cases for Japan, for Products with a Japan Product Code Type of J-Drug Code, Vault maps information to the G.k.2.3.r.1 Substance / Specified Substance Name data element as follows:
- For Company Products, Vault maps the first seven (7) digits of the Local Product Code if available.
- For External Products, Vault maps the first seven (7) digits of the Local MPID if available.
After configuring this feature, for more information on how Substance codes are exported, see the G.k.2.3.r section of PMDA E2B(R3) Generation Data Mapping.
Prerequisite
This feature is Auto-on, however, some components require additional configuration. Before configuring this feature, ensure you have enabled the Japan Drug Dictionary.
Update the Case Product Registration Layout
Complete the following steps to add the Japan Product Code Type field to the Case Product Registration object layout on Domestic Cases for Japan:
- Go to Admin > Configuration > Objects > Case Product Registration > Layouts > Japan Detail Page Layout.
- In the Details section, add the Japan Product Code Type field.
- Select Save.
Check Permissions
Users with the applicable permission sets should automatically see the following fields:
- Product Name
- Manufacturer
- Local MPID
- Japan Drug Code Type
If any users do not see these fields, check Atomic Security settings. For more information, see Configuring Atomic Security on Fields in Configuring Atomic Security for Objects.