MHRA guidance on how to complete your Electronic Application Form (eAF) and Cover Letter

Last updated: 4 February 2022

See updates at the bottom of the page.

The UK MHRA has provided guidance on how to complete your Electronic Application Form (eAF) and Cover Letter.

The guidance has been provided as an electronic tool.

What is the tool designed to do?

The tool is designed to help applicants determine the additional information required in the Cover Letters and eAFs of initial MAA and variation applications.

How does the tool work?
  • Click on ‘eAF and cover letter tool’
  • You will now see a pdf. Highlight it by clicking on it. Don’t double-click on it to open the pdf
  • Now extract the file by clicking on the MS office feature ‘Extract all’ at the top of your screen and following the instructions
  • Once done, you can open the pdf by double-clicking on i. ALternatively, you can right click on the pdf, save it and then open it.
  • Now select the appropriate ‘Application type’ and then ‘Application territory’ and ‘Application legal basis’. Answer any further question(s) that appear on selecting the appropriate options for these three fields.
  • Once completed, click on the ‘Results’ button at the bottom.
  • This will reveal a useful list of information on:
    • which application form to use and instructions on how to complete the application form
    • statements/ information that should be added to the cover letter accompanying that particular application.

Failure to submit the appropriate information in the cover letter and the dossier may result in the application being invalidated.

4 Feb 2022Section entitled How does the tool work updated substantially to make the instructions clearer.
20 January 2021Updated ZIP file “eAF and Cover Letter – Advice Tool”