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Best practice guidance on patient information leaflets


At Label Craft in Ireland, we have clients globally that we distribute patient information leaflets for both the EU and UK. Recently UK companies have been working with us to distribute across Europe from Ireland, largely an economic decision since Brexit.


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.

The document for best practice guidance as published on can be viewed as a PDF or downloaded here :


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.


If you are interested in contacting one of our sales team to discuss producing patient information leaflets, please email us via





At Label Craft we strive to always streamline and ensure quality control in our process. If you would like to discuss manufacturing your labels, cartons or patient information leaflets please don’t hesitate to contact one of our friendly sales team at




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