MHRA consultation on statutory fees - proposals on ongoing cost recovery
- From:
- Medicines and Healthcare products Regulatory Agency
- Published
- 29 August 2024
- Last updated
-
236OctoberMarch20242025 — See all updates
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Government response to MHRA consultation on statutory fees: proposals on ongoing cost recovery
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Government response to MHRA consultation on statutory fees: proposals on ongoing cost recovery
PDF, 461 KB, 54 pages
This file may not be suitable for users of assistive technology.
Request an accessible format.
Detail of outcome
The MHRA’s fees are updated on a regular basis to ensure we continue to achieve full cost-recovery in line with HM Treasury guidance Managing Public Money. This helps ensure ongoing financial sustainability and delivery of services.
The MHRA held a public consultation on proposed amendments to its statutory fees. The consultation ran between 29 August 2024 and 24 October 2024 and was held jointly with the Department of Health in Northern Ireland, in accordance with Section 45(1) of the Medicines and Medical Devices Act 2021.
This document summarises the responses to the consultation and outlines our response to feedback and proposed next steps.
The majority of respondents did not agree with the proposal for a new medical devices registration fee. The decision has been taken to proceed with the wider fees uplift and continue exploring options on this fee. The implementation date for the proposed changes is early Q1 2025/26.
Further guidance on the proposed changes will be published on our fees page in due course and will be informed by the feedback given. Given the necessary steps to implement the changes, it is likely that the updated medicines fees will be implemented slightly before the fees for medical devices and blood products for transfusion.
Original consultation
Summary
Consultation on proposals to update the MHRA's statutory fees to ensure they continue to recover their costs.
This consultation closesran atfrom
to
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 info@mhra.gov.uk.
Documents
MHRA consultation on statutory fees - proposals on ongoing cost recovery
PDF, 787 KB, 53 pages
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Updates to this page
Published 29 August 2024
Last updated 236 OctoberMarch 2024
2025
+ show all updates
-
Published Government response to consultation.
-
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.
-
-
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'
-
-
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’.
-
-
First published.
Sign up for emails or print this page
Update history
2025-09-02 13:14
MHRA have published an update to the original government response, which details the changes made to proposal for a new annual medical devices registration fee to support post-market surveillance (PMS) activities (Proposal 2, in the original consultation).
2025-03-06 13:39
Published Government response to consultation.
2024-10-23 17:57
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.
2024-10-21 12:51
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’
2024-09-10 12:20
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’.
2024-08-29 17:02
First published.
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 info@mhra.gov.uk.
Documents
MHRA consultation on statutory fees - proposals on ongoing cost recovery
PDF, 787 KB, 53 pages
Share this page
The following links open in a new tab
Updates to this page
Last updated
-
Published Government response to consultation.
-
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.
-
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'
-
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’.
-
First published.
Sign up for emails or print this page
Update history
2025-09-02 13:14
MHRA have published an update to the original government response, which details the changes made to proposal for a new annual medical devices registration fee to support post-market surveillance (PMS) activities (Proposal 2, in the original consultation).
2025-03-06 13:39
Published Government response to consultation.
2024-10-23 17:57
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.
2024-10-21 12:51
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’
2024-09-10 12:20
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’.
2024-08-29 17:02
First published.