MHRA Windsor Framework for Human Medicines

The Medicines & Healthcare Products Regulatory Agency (MHRA) has introduced the Windsor Framework, establishing new UK-wide licensing and labeling standards for manufacturers and wholesalers.

Key Points:

• Labeling Requirement: Starting January 1, 2025, medicines must have a ‘UK Only’ label to prevent supply to EU or EEA markets.
• Authorization: The MHRA will authorize new medicines and those currently under the EU Centralized Authorization Procedure for the UK.
• Falsified Medicines Directive: The UK will disapply the Falsified Medicines Directive on December 31, 2024, making the UK repository inaccessible.
• Safety Features: UK-licensed packs must not include EU FMD safety features or recognized 2D barcodes.
• Qualified Persons (QPs): QPs must be UK residents; the MHRA’s remote certification policy remains unchanged.
• Compliance for Existing Medicines: Medicines released before December 31, 2024, may not comply with MHRA guidance but can continue to circulate under their existing marketing authorization until dispensing or expiry.

Source: https://www.gov.uk/government/publications/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework

Region: EU Harmonized (27 Markets), Northern Ireland (UK), United Kingdom