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
Title:
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
Short Title:
Excipients in the label and package leaflet of medicinal produc
Origin/Publisher:
European Commission
Document Type:
Notice to applicants
Content:
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.