Guidance

Baseline guidance for medicine licence submissions

Definitions of baseline submissions for medicine licences and when they should be used.

Documents

MHRA baseline guidance

This file may not be suitable for users of assistive technology. Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gsi.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

This guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) includes scenarios that need baseline submissions and reminders and tips.

Published 1 December 2015