Guidance

Best practice guidance on patient information leaflets

This guidance sets out the legal framework for patient information leaflets as described in EU and national legislation and best practice in the area of information design.

Document

Best practice guidance on patient information leaflets

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

As part of a move towards an increase in self-regulation of medicines labelling and patient information, this guidance has been developed to help those responsible for the design and content of patient information leaflets.

It sets out the legal framework for patient information leaflets as described in EU and national legislation and it describes best practice for information design to ensure that patients who rely on the information provided can make informed decisions about the safe and effective use of the medicines they take.

This document is guidance and is not a legal interpretation of national and EU regulations.

Published 29 December 2014