MHRA consultation on statutory fees - proposals on ongoing cost recovery
Consultation description
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 MHRA’s 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 MHRA’s 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.
Statutory fees for SMEs: Webinar about the MHRA consultation
Watch the Statutory fees for SMEs: Webinar about the MHRA consultation for further information.
Statutory fees for SMEs: Webinar
Contact us
If you have any questions about your consultation response or are experiencing any problems, please email [email protected].
Documents
Updates to this page
Published 29 August 2024Last updated 23 October 2024 + show all updates
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Update to the value of “38. Wholesale distribution authorisations: fees - New Applications - Standard application plus full inspection fee” from £1,880 - £2,047 to £4,645 - £5,056.
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Minor changes to update terminology for medical devices fees, and to update a duplicated reference to a fee & video link added to webinar 'Statutory fees for SMEs: Webinar about the MHRA consultation for further information'
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Following early feedback from customers and stakeholders, we have clarified some terms in the consultation document relating to Priority 2: The MHRA proposes to amend its existing Medical Device Registration fee to include the costs for medical device post-market work. In this section we have replaced the term ‘category’ with ‘code’ and the term ‘supplier’ with ‘manufacturer’.
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First published.