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
2015 NovemberMay 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 2015 NovemberMay 2023 + show all updates

  1. Updated to include fees regarding International Recognition.

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

  3. 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. Updated MHRA fees for 2023 - 2024

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

  6. CURRENT FEES UPDATED

  7. Changes to MHRA fees for 2021 - 2022

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

  12. We have updated the years references to the periodic fees

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

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

  15. Information about 2017/18 fees added to the page.

  16. MHRA's fees changed on April 1 2016.

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

  18. First published.