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UK MHRA Guidance: Navigating New MHRA Payments & Fees guidance

The Medicines and Healthcare products Regulatory Agency (MHRA) plays a pivotal role in regulating medicines, medical devices, and related services in the UK. Paying the correct fees promptly and accurately is essential to ensuring smooth regulatory workflow—from clinical trial approvals to marketing authorizations.

On 2 September 2025 MHRA updated its guidance on how to make payments (excluding device registration and Certificates of Free Sale) and to get clear insight into the current fee landscape.


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How to Make Payments to MHRA (Excluding Device Certifications)

Who This Applies ToThis payment guidance is relevant to all MHRA-related applications—including medicines, clinical trials, and licensing—except for Device Registration and Certificates of Free Sale. Those are processed separately via the Device Online Registration System (DORS).


What You’ll Need from the Invoice

Once your application passes validation, MHRA will issue an invoice. You must pay this promptly to avoid potential penalty fees, licence suspensions, or even legal proceedings for debt collection. Be sure to include both the invoice number and your customer number in your payment to ensure proper payment allocation.


Accepted Payment Methods

Credit or Debit Card

MHRA accepts Visa, Mastercard, Maestro, Delta, Visa Electron, and American Express payments 24/7 through a secure online portal. Always quote the invoice number to ensure proper processing.

Bank Transfer

Make payments directly to MHRA’s bank account with the following details:

Account Name: MHRA

Account Number: 10004386

Sort Code: 60-70-80

SWIFT Code: NWBKGB2L

IBAN: GB68NWBK60708010004386

Bank: National Westminster Bank, London Corporate Service Centre

More info at Pay by bank transfer.

Cheques

MHRA no longer accepts cheque payments, so do not attempt to pay by mail.

Internal Purchase Orders & Payment Queries

If your organization requires a Purchase Order (PO), ensure it is issued before the invoice is generated. However, invoice payment deadlines must be met regardless of PO receipt. For payment disputes or questions, contact MHRA Accounts Receivable or specific divisions based on your service area.Refer to the MHRA payment guidance contact section for dedicated emails.

Understanding Current MHRA Fees (2025–2027)

The MHRA fee structure is revised periodically to cover operational costs and support sustainable regulation. The latest fee schedule effective from April 1, 2025, through March 31, 2027, includes updates on fees across sectors: medicines, blood banks, medical devices, clinical trials, and regulatory advice.

The full detailed schedule is available here: Current MHRA Fees.

Highlights include:

  • New and renewal fees for active pharmaceutical ingredient manufacturers and importers.

  • Updated clinical trial application fees that vary based on trial complexity.

  • Medical device clinical investigation fees scaled by device classification.

  • Regulatory advice meetings charged £987 per session, introduced to provide early clarity to applicants.

  • Several fee increases indexed to inflation and operational cost rises, balanced by SME easements allowing fee payment in installments.

  • Notably, plans for annual per-GMDN (Global Medical Device Nomenclature) code medical device fees were dropped after stakeholder feedback to avoid supply disruption risk.


At-a-Glance Summary

Topic

Key Takeaways

Who pays via this process?

All MHRA applications except device registrations and Free Sale certificates.

Accepted payment methods

Credit/debit cards via GOV.UK Pay or bank transfers.

Cheques

No longer accepted.

Invoice handling

Must include invoice & customer numbers; POs cannot delay payment.

What to avoid

Late payments, missing references, reliance on postal docs.

Fee updates (2025–2027)

Indexed increases; SME easements; new advisory fees apply.

Dropped proposal

No annual per-GMDN registration fees for medical devices.

Using the secure GOV.UK Pay portal or bank transfers with accurate invoice references, ensuring invoices are paid promptly, and understanding the latest fee schedule will ensure regulatory compliance and help avoid delays or penalties.

For a comprehensive understanding, official forms, and live updates, always refer to the linked MHRA payment guidance and the detailed fee schedules.

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The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

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