MHRA Windsor framework updates

Summary

MHRA Windsor Framework updates (Enhancement 37661328)

Description

Windsor Framework came into force on 01 January 2025 to enable medicines to use the same packaging and labelling across the UK and allow additional medicines to be approved and licensed on a UK-wide basis by the MHRA.

Argus is enhanced to include a new License Category field in Console > Products and Licenses > License configuration. The License Category is a drop-down driven by a flexible code list, allowing single value selection per license.

The License Category values are configured in Console > Code Lists > Flexible Data Re-Categorization, under the following:

• Code List Name: LICENSE_CATEGORY_OTHER
• Factory values:
  • Category 1 – UK only license
  • Category 1 – UK and EU license
  • Category 2 – UK only license
  • Category 2 – UK and EU license

The License Category field is blank by default and is not a mandatory field. It does not appear in the case form. While this update is intended for UK licenses at the License level, it is available for all product licenses. Customers are advised to configure Products and Reporting Rules in order to adhere to MHRA Windsor framework guidelines.

For more information, refer to the OracleArgusSafety2026.1.01_CaseForm_Console_Updates_Summary document.