Guidance: UK-Wide Licensing for Human Medicines

MHRA to License Medicines Across the UK Under the Windsor Framework (Effective 01-Jan-2025)

The Medicines and Healthcare Products Regulatory Agency (MHRA) will begin licensing all medicines across the UK under the Windsor Framework starting 01-Jan-2025, including centrally authorized products.

Key Updates

• Territorial Application and Licensing
  • All existing licenses will automatically convert to UK-wide licenses.
  • New Marketing Authorization Applications (MAAs) will be granted as UK-wide licenses.
  • Specific actions may be required in certain scenarios to maintain compliance.
• Management of Licenses
  • Licenses will be managed based on the EU procedure and the Windsor Framework guidelines.
  • The CAP bridge mechanism will remain in effect until 31-Dec-2024.
• Reference Medicinal Products (RMPs) and Data Exclusivity
  • The use of RMPs and Data and Marketing Exclusivity (DME) periods will undergo changes to align with the framework.
• Pharmaceutical Licenses (PLGBs)
  • PLGB licenses will become valid across the UK starting 01-Jan-2025, unless canceled by the MHRA before 31-Dec-2024.
• Windsor Framework Provisions
  • The European Commission’s CAP authorization for Northern Ireland remains valid until 01-Jan-2025.
  • MAAs for UK-wide generics must reference centrally authorized products until the end of 2024.
• EU Regulatory Guarantees
  • The UK must provide written guarantees to the European Commission as required under EU Regulation 2023/1182 and Article 14.

Implications for Pharmaceutical Companies

These changes will impact regulatory processes, the territorial application of licenses, and compliance obligations. Companies are encouraged to prepare for the transition to UK-wide licensing by reviewing license statuses and aligning with MHRA guidelines.

For further information, consult the MHRA’s official guidance or seek expert advice to navigate these updates.

Source:https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines/uk-wide-licensing-for-human-medicines#territorial-application
Region:United Kingdom