Guidance

Cancel a medicine's marketing authorisation or other licence

Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 2 October 2015 — See all updates

You must cancel your marketing authorisation (MA), parallel import product licence and/or traditional herbal remedy registration, before a product can be removed from the market.

If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it.

Cancellations

To cancel a marketing authorisation for a medicine or a traditional herbal remedy so it can be removed from the market, you need to:

1. Follow the European requirements on the European Medicines Agency (EMA) website completing and submitting their cover letter template and notification report table.

2. Complete the cancellation form (MS Word Document, 33.5 KB) if you’re a UK applicant as well as following the European process at step 1.

Or if you need to cancel a parallel import product licence, complete the cancellation form (PDF, 525 KB, 3 pages).

Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form.

Submit your forms

Submit the relevant forms above to MHRA via the MHRA portal if you’re a UK applicant. You will need to register if you haven’t already.

Or you can submit the forms to us by email to withdrawcancel@mhra.gov.uk

You can also submit the forms via the Central European System Platform (CESP).

Withdrawals

If you have submitted an application for a new MA, traditional herbal remedy and/or a parallel import product licence and you no longer want to proceed with application, you need to submit a withdrawal form. You should also use this form if you want to withdraw a variation application or amendment for an existing MA.

Complete the application to withdraw a pending application (MS Word Document, 35 KB) for and email it to us with ‘withdrawal’ as your subject line.

More information

Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements.

Published 18 December 2014
Last updated 2 October 2015 + show all updates

1. 2 October 2015

   You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017.

2. 18 December 2014

   First published.