Guidance

Best practice in the labelling and packaging of medicines

This guidance explains the legal framework for labelling and packaging as described in UK legislation and gives best practice for producing medicines labelling and packaging.

Documents

Best practice guidance on the labelling and packaging of medicines

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.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 packaging, this guidance has been developed to aid those responsible for the origination of labelling and packaging artwork. It sets out the legal framework for labelling and packaging as described in UK legislation.

In addition, it describes best practice in the area of labelling and packaging to ensure that medicines can be used safely by all patients, the public and healthcare professionals alike.

It also reflects the expectations of healthcare professionals, patients and regulators with respect to reduction in medication errors, and safe selection and use of medicines by all users

This guidance does not constitute a legal interpretation of the requirements on medicines labelling and packaging as set down within the Human Medicines Regulations 2012 [SI 2012/1916] as amended].

Published 29 December 2014
Last updated 31 December 2020 + show all updates
  1. Updated to reflect changes in regulations following Brexit transition.

  2. First published.