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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 29 December 2014
• Last updated: 31 December 2020 — See all updates

Documents

Best practice guidance on patient information leaflets

PDF, 706 KB, 30 pages

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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 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 regulations.

Published 29 December 2014
Last updated 31 December 2020 + show all updates

1. 31 December 2020

   Updated to include arrangements in relation to EU exit.

2. 29 December 2014

   First published.