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Licensing: how to apply
How to license a medicine for sale in the UK, including national and international routes, and information on fees.
There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the type of application.
National routes
International routes (collaborative procedures)
If you want to market a medicine in the UK, Australia, Canada, Singapore and/or Switzerland work-sharing procedures are available through the Access Consortium.
How to apply for a licence
You need to follow a specific application procedure depending on the licence (marketing authorisation) you need. Applications must be submit through the MHRA submissions portal.
Fees
MHRA charges a fee for some services.
Published 4 May 2021