Electronic Application Form (eAF) and Cover Letter Tool

On 20 January 2022 the MHRA updated the guidance on how to complete the eAF and cover letter.

This tool is designed to help applicants determine the additional information required in the Cover Letters and eAFs of initial and variation applications contained in the “eAF and Cover Letter Advice Tool” .zip file.

The user should answer all of the questions in the tool fully to make sure that all the correct information required for the application is included. Failure to submit the appropriate information in the cover letter and the dossier may result in the application being invalidated.

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