Medicines licensing: how to apply
Links to help choose an application route and legal basis for a marketing authorisation (MA). And information on getting advice, practical procedures, fees and variations.
You will need a licence, known as a marketing authorisation (MA), for a human medicine the United Kingdom (UK) or Northern Ireland.
See how to choose your application route and legal basis. And information on getting advice, practical procedures and fees.
Choose your application route
An application route is the regulatory process that will be used for the evaluation of the evidence supporting your medicine’s marketing authorisation.
Members of the Access Consortium work together to promote greater regulatory collaboration and alignment of regulatory requirements including through work-sharing procedures. The consortium members are UK, Australia, Canada, Singapore and Switzerland.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster. It is an international programme co-ordinated by the US Food and Drug Administration (FDA).
Choose your legal basis
Your legal basis determines the nature and scope of evidence and data you need to provide to support your application.
Get scientific advice for your application
If you need advice on which route is most appropriate or on the nature and extent of supporting scientific data required you can ask for advice from the MHRA.
How to apply for a licence
Practical information on the application processes including templates and checklists.
Applications must be submitted through the MHRA submissions portal.
Fees
MHRA charges a fee for all new marketing authorisations.
Product naming, packaging and leaflets
Your medicine must have a clear name in line with legislative requirements so that it can be used safely.
Vary your MA
If you already have an MA you may need to change its terms. For example you may need to amend the information that supports your MA for changes to: - the method of manufacture - product specification - safety information - how it is prescribed or used
You must apply for a variation to your marketing authorisation to make these changes.
Renew your MA
Transfer ownership of your MA
Updates to this page
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Added new sections on varying, renewing and transferring ownership of a marketing authorisation. And added explanatory text to sections to improve navigation.
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Updated to add 'National assessment procedure for medicines' to Licensing: How To Apply
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Added link to 'International Recognition Procedure guidance'.
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First published.