Guidance

Warning statements for labels and leaflets of certain medicines

This guidance sets out the warning statements which should appear on the label and/or in the leaflet of certain medicines.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 29 December 2014
• Last updated: 3 February 2020 — See all updates

Documents

Additional warning statements for inclusion on the label and/or in the leaflet of certain medicines

PDF, 419 KB, 49 pages

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Details

Warning statements need to be added to the labels and leaflets of certain medicines. The words in this guidance do not need to be used verbatim but that have already been user tested and are in use on dispensing labels applied in pharmacies across the UK.

The warning statements are divided into general and specific categories and for some medicines warnings from both sections may need to be applied.

Published 29 December 2014
Last updated 3 February 2020 + show all updates

1. 3 February 2020

   An updated version of this guidance was published in September 2019.

2. 29 December 2014

   First published.