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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 2 October 2026
• Last updated: 9 October 2026
  Show all updates

  1. 9 October 2026

     Updated to make 'How to Apply' section more clear

  2. 2 October 2026

     First published.

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:

• Initial Marketing Authorisation Application (MAA) - Version 1.26.0.0 (PDF, 887 KB, 1 page)
• Variation application - Version 1.28.1.0 (PDF, 545 KB, 1 page)
• Renewal application - Version 1.26.0.0 (PDF, 350 KB, 1 page)

How to apply

1. Download and save the form on your local computer. Please use *Adobe Acrobat Reader to open the form. You will be presented with a warning message suggesting “Some features have been disabled to avoid potential security risks”. Please click on “options” and choose to “trust this document”. this will unlock all features embedded in the form to support validation.
2. 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.
3. To validate and save the completed form, right-click the document, choose “Save-link as” and download a local copy.
4. Include the completed eAF within your eCTD submission package.

*Please note that applicants should use Adobe Reader or Adobe Reader DC for locking the forms. Adobe Acrobat or Acrobat Pro DC should not be used for filling and locking the forms as this may cause issues when the locked forms are opened/viewed by the recipient who may be using Adobe Reader/Adobe Reader DC.

All other submission requirements remain unchanged.

Further Guidance

Practical User Guide for Electronic Application Forms (eAF) for human and veterinary medicinal products in the EU

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.