Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A VACCINE ANTIGEN MASTER FILE (VAMF)
Title:
Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A
VACCINE ANTIGEN MASTER FILE (VAMF)
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Guideline
Content:
This Guideline on submission of vaccine antigen master files (VAMFs) is intended to inform Applicants of the implementation of Annex I of Directive 2001/83/EC as amended by Commission Directive 2003/63/EC.