UK MHRA Guidance: How to Cancel a Medicine’s Marketing Authorisation or Other Licence

Sharan Murugan
Aug 19
2 min read

In the pharmaceutical lifecycle, there are times when a marketing authorisation holder (MAH) needs to cancel a medicine’s marketing authorisation (MA), traditional herbal registration, or a parallel import product licence (PIPL), or withdraw a pending submission. Whether due to business strategy, regulatory changes, or product discontinuation, understanding the Medicines and Healthcare products Regulatory Agency (MHRA) process for cancellations and withdrawals is crucial for compliance and operational efficiency.

This guidance clarifies the process by which a licence holder may cancel a UK Marketing Authorisation (MA), Traditional Herbal Registration, or Parallel Import Product Licence, or withdraw a pending application.

What is a Marketing Authorisation or Product Licence?

Marketing Authorisation (MA): Legal permission to market/sell a medicinal product in the UK, granted by the MHRA (or previously EU centrally via the EMA).
Parallel Import Product Licence (PIPL): Authorisation for importing a medicine from another country in the European Economic Area, where it is already authorised by a competent authority.
Traditional Herbal Registration (THR): For traditional herbal medicines meeting specific safety and quality standards.

Cancellations: How to Remove a Product from the Market

When to Cancel

When you wish to remove a licensed medicine, herbal remedy, or parallel imported product from the UK market.
Cancellation is compulsory before a product can be discontinued in the UK.

The Process

1. Meet European Requirements

For products also registered with the European Medicines Agency (EMA):
- Follow EMA requirements—use their cover letter template and notification report table (available on the EMA website).
- Complete the related notification for the MHRA as well (if you are a UK applicant).

2. UK-Specific Forms

For UK-only MAs, THRs, and herbal products:
- Complete the appropriate MHRA cancellation forms.
For PIPL cancellations:
- Complete the parallel import product licence cancellation form.

3. Bulk Cancellations

You may submit up to 10 product licences per cancellation application form.

4. Submit Your Application

Use the MHRA Portal (registration required) for efficient and secure submission.
Alternatively, email the forms to: withdrawcancel@mhra.gov.uk
CESP (Central European System Platform) submissions are also accepted.

Timing

To avoid extra periodic fees, cancel your marketing authorisation by 31 December if you want it to be cancelled by 31 March of the next year (e.g. by 31 Dec 2025 for a 31 Mar 2026 effective date).

Withdrawals: Pulling Back Pending Submissions

When to Withdraw

For applications that have been submitted but not yet approved (including MAs, THRs, PIPLs, as well as variation or amendment requests).

The Process

Complete the withdrawal form (available on the MHRA site).
Email your completed form to MHRA with the subject line “withdrawal.”

Practical Considerations & Best Practices

Scenario	What to Do
Removing product from market	Submit EMA letter + MHRA cancellation form via portal/email/CESP.
Stopping pending application	Submit "withdrawal" form via email.
Missed renewal fee	Cancel before year-end to avoid incurring a new renewal.
Regulatory enforcement by MHRA	MHRA may revoke/suspend based on safety or compliance issues.