GovWire

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking views from interested stakeholders on proposals to update its statutory fees to ensure they continue to recover their costs.

The MHRAs fees are updated on a regular basis to ensure they continue to achieve full cost-recovery in line with HM Treasury guidance Managing Public Money.

This is necessary for long-term financial sustainability and the ongoing delivery of the MHRAs services.

The implementation date for these proposed changes is April 2025.

Information sought

We are seeking views on the following proposals:

• Increasing the statutory fees shown in its consultation document to ensure continued cost-recovery until 2027.
• Amending the existing Medical Device Registration fee to include the costs for medical device post-market work.
• Creating a new service providing regulatory advice meetings for medical devices.
• Amending the fee model for three existing services, as well as increasing the fees to ensure continued cost-recovery until 2027, and also to remove 51 fees that are no longer in use.
• Updating and clarifying the legal definition of a standard variation application for homeopathic products. The standard variation application statutory fee for homeopathic products will be unchanged.

Contact us

If you have any questions about your consultation response or are experiencing any problems, please email info@mhra.gov.uk.