Guidance

Electronic Application Form and Cover Letter Tool

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 30 March 2021
• Last updated: 20 January 2022 — See all updates

Documents

eAF and Cover Letter Tool

ZIP, 3.98 MB

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Details

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

You should answer all of the questions in the tool fully to make sure that you are including all the correct information required for your application. Failure to submit the appropriate information in the cover letter and the dossier may result in the application being invalidated.

Published 30 March 2021
Last updated 20 January 2022 + show all updates

1. 20 January 2022

   Updated ZIP file "eAF and Cover Letter - Advice Tool"

2. 30 March 2021

   First published.