Eudralex Volume 3 VOLUME 3B Guidelines - Medicinal products for human use. Safety, environment and information: Excipients in the label and package leaflet of medicinal products for human use

Eudralex Volume 3 VOLUME 3B Guidelines - Medicinal products for human use. Safety, environment and information: Excipients in the label and package leaflet of medicinal products for human use

Excipients in the label and package leaflet of medicinal produc

Notice to applicants

This guideline is for use by competent authorities, applicants for a Marketing Authorisation and Marketing Authorisation Holders. The Annex provides a list of the excipients which should be stated on the labelling and outlines the information which should appear in the package leaflet, for these excipients. This guideline does not apply to these substances when they are used as active substances.