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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
Internet:

https://www.gmp-compliance.org/files/guidemgr/3bc7a_200307en.pdf

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.

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