Safe Labelling of Excipients in Medicines

Published: 20/7/2020

Deadline is approaching.

In October 2017, the EMA and the European Commission initially updated the annex to the excipient guideline, which contains the information that should appear in the labelling and package leaflet for the excipients known to have a recognised action or effect. EMA published a new version of such updated annex in November 2019, after a public consultation for each excipient, adoption by EMA's Committee for Medicinal Products for Human Use (CHMP) and endorsement by the European Commission's Notice to Applicants Group.

An excipient is a constituent of a medicine other than the active substance, added in the formulation for a specific purpose. Excipients are considered to be the "inactive" substances in the medicinal product however, some have a known action or effect in certain circumstances and such must be stated as warnings on the labelling of the medicines, in order to ensure their safe use.

The annex contains all the excipients that must be declared in a medicine's labelling and package leaflet and their agreed safety warnings. The 2017 update included 5 new excipients to be considered and new safety warnings for 10 existing excipients that should be implemented in the labelling and package leaflet of the medicine by October 2020.

This annex is applicable to centrally and nationally authorised products within the EU. For new marketing authorisations, the marketing authorisation holder must implement the information stated in the latest annex in their proposed product labelling. For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the latest annex. For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type IB variation within 3 years after the publication of the revised annex which means that for the initial impacted excipients the variation needs to be submitted by October 2020 (to implement the 2017 safety updates).

The current effective version of the updated annex can be found here:…al-products-human_en.pdf

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