Eudralex Volume 3 Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product EMEA/CHMP/QWP/396951/2006
Title:
Eudralex Volume 3 Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product EMEA/CHMP/QWP/396951/2006
Origin/Publisher:
EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Document Type:
Guideline
Content:
This guideline describes the information that needs to be submitted in relation to excipients including antioxidants and antimicrobial preservatives, in the context of applications for marketing authorisations or variations relating to an excipient in authorised medicinal products.