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
Titel:
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
Kurztitel:
Excipients in the label and package leaflet of medicinal produc
Internet:
Herkunft/Verlag:
European Commission
Dokumentenart:
Notice to applicants
Inhalt:
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.