Guidance
Electronic Application Forms (eAF) for UK medicines licensing applications
Current eAF forms are available for applicants to download and use. Existing submission routes, validation requirements and assessment processes remain unchanged.
Overview
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.
Download an electronic Application Form (eAF)
Download the appropriate form below:
How to apply
- Download and complete the relevant eAF form using Adobe Acrobat Reader.
- Where the form requests a country selection and United Kingdom is not available, use your Organisation ID (OrgID) or Location ID (LocID) from the EMA Organisation Management Service (OMS) portal to search for and select the appropriate organisation and address record.
- Validate and save the completed form.
- Include the completed eAF within your eCTD submission package.
All other submission requirements remain unchanged.
Related guidance
- Apply for a licence to market a medicine in the UK
- Apply for a variation to your marketing authorisation
- Renewing marketing authorisations for medicines
- Register to make submissions to the MHRA
Further help
If you have questions about applying, please contact the relevant MHRA submission team using the contact details provided in the associated guidance.