Statutory guidance

MHRA fees

Fees payable to the MHRA for 2023 to 2024

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 20 November 2023 — See all updates

Documents

Current MHRA fees

HTML

MHRA fees definitions

PDF, 148 KB, 7 pages

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Payment easements and waivers for small and medium companies

HTML

Fees extracts

PDF, 124 KB, 2 pages

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Fees for new suppliers of defined simple active pharmaceutical ingredients (APIs)

PDF, 20.2 KB, 3 pages

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Details

The document attached lists MHRA fees for 2023 to 2024. It incorporates new EU Exit fees which came into force on 1 January 2021.

For further information on EU Exit fees see The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020.

Published 18 December 2014
Last updated 20 November 2023 + show all updates

1. 20 November 2023

   Updated to include fees regarding International Recognition.

2. 15 May 2023

   Amendment fees added to our 'Current MHRA fees' webpage.

3. 21 April 2023

   Added links to Fees page: The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 & The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023

4. 1 April 2023

   Updated MHRA fees for 2023 - 2024

5. 8 March 2023

   Added link to application form to 'apply for Small and Medium Company status'.

6. 5 September 2022

   CURRENT FEES UPDATED

7. 1 April 2021

   Changes to MHRA fees for 2021 - 2022

8. 3 March 2021

   Published a new version of the 'Payment Easements and Waivers for Small and Medium Companies, as a HTML document. This replaces the 'Payment Easements for Small Companies' PDF.

9. 12 February 2021

   Update on the MHRA fees for Licence applications: marketing authorisations; Orphan Marketing Products: fees; Variations: licence variations application fees; Variations: licence variations applications groups fees; and Variations: Traditional Herbal Registration Scheme fees

10. 31 December 2020

    Added new information on fees following the end of the transition period. This includes new sections on orphan marketing products, Pharmacovigilance (PV) Safety Reviews, pre-assessment (rolling review) fees, PMF and Vaccine Antigen Master File certification.

11. 28 August 2020

    Amended text under 'Current MHRA fees' guidance. Section '13. Inspection: fees'.

12. 31 March 2020

    We have updated the years references to the periodic fees

13. 4 February 2020

    Update to confirm fee levels for 2020 to 2021 are remaining the same as 2019 to 2020

14. 3 August 2018

    Minor amendment to the explanation of the Office Based Inspection Fee to include information that was left out by mistake.

15. 1 April 2017

    Information about 2017/18 fees added to the page.

16. 1 April 2016

    MHRA's fees changed on April 1 2016.

17. 31 March 2016

    MHRA's fees change on April 1 2016. Uploaded a PDF of the changed fees.

18. 18 December 2014

    First published.