The MHRA Issues Final Call to Comply with Windsor Framework Arrangements for Medicines from January 2025
29 November 2024
Introduction
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a final call to action for businesses to comply with the new arrangements for the regulation of medicines under the Windsor Framework agreement. The new arrangements will come into effect on 1 January 2025.
Key Changes
Under the new arrangements, all medicines placed on the market in the UK will need to be authorized by the MHRA. This includes medicines that are currently authorized by the European Medicines Agency (EMA).
Businesses will need to apply for a new UK marketing authorization (MA) for any medicines that they wish to continue to market in the UK after 1 January 2025. The MHRA has set out a number of deadlines for businesses to submit their applications.
Deadlines
- For centrally authorized medicines, applications must be submitted by 1 January 2025.
- For nationally authorized medicines, applications must be submitted by 1 July 2025.
- For generic and biosimilar medicines, applications must be submitted by 1 January 2026.
Support for Businesses
The MHRA is providing a range of support to businesses to help them comply with the new arrangements. This includes:
- A dedicated helpline for businesses
- A series of webinars and workshops
- Guidance documents on the new requirements
Next Steps
Businesses should take immediate steps to prepare for the new arrangements. This includes:
- Reviewing the MHRA’s guidance documents
- Identifying which medicines will need to be re-authorized
- Submitting applications for new MAs by the relevant deadlines
Failure to comply with the new arrangements could result in medicines being withdrawn from the UK market.
Conclusion
The MHRA’s final call to action is a reminder to businesses that they need to take action now to ensure that they are ready for the new arrangements under the Windsor Framework. By working together, we can ensure a smooth transition to the new regulatory framework and continue to provide patients with access to safe and effective medicines.
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