Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'

Current effective version

PDF iconAnnex (EN)
Information for the package leaflet in other European Union/ European Economic Area languages:

Reference numberEMA/CHMP/302620/2017
Published09/10/2017
Effective from09/10/2017
KeywordsExcipients, package leaflet, labelling
DescriptionThis document is the Annex to the European Commission guideline on Excipients in the labelling and package leaflet of medicinal products for human use. It contains the information which should appear in the package leaflet for the excipients known to have a recognised action or effect.


Document history

Revision 2
Current version

Adopted annex

Concept paper

Published: 09/10/2017

Published: 07/03/2012

Revision 1

PDF iconAnnex of 2003 guideline

In operation: 01/07/2003 - 09/10/2017


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