Apply for a licence to market a medicine in the UK

This information is common to all routes of application.  Read the guidance for a specific pathway for any extra information or steps that might be required. The pathway that is followed will depend on the type of application being made. 

The MHRA continues to accept electronic Application Forms (eAFs) for UK medicines licensing applications. As an interim business continuity measure, MHRA is making the current eAF forms available for applicants to download and use.

Existing submission routes, validation requirements and assessment processes remain unchanged. All UK MA applications should be submitted through the MHRA Submissions Portal.

Any questions about the Submissions Portal should be sent by email to[email protected]. 

The application should be submitted using the electronic Common Technical Document (eCTD).  

The pre-submission checklist (PDF, 129 KB, 7 pages) and the eAF and cover letter tool should be used to determine what documents and information to include in the application. If the correct documents and information are not submitted the application will not be validated. 

The MHRA checks that eCTD submissions are technically valid using the Lorenz Docubridge validation tool which strictly aligns validation against the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) international standards and eCTD 3.2 regional requirements. It is recommended that a validation tool is used to check the submission.  

For more information on the standards visit:  

If there are any questions about submitting an application, please contact: 

If applying for a UK or Northern-Ireland MA, then a PL number must be sought from the MHRA Portal  or by emailing  [email protected]  before you submit the application. 

When requesting a PL number, please note the following prefixes and their definitions: