Requirements for vaccine antigen master file certification - Scientific guideline

This document is intended to provide guidance on issues associated with the submission, evaluation and certification of the vaccine antigen master file (VAMF). Applicants should note that EMA will not update this guideline due to limited interest in the VAMF tool. However, interested companies and individuals may still apply as the guideline remains valid.

Keywords: Vaccine antigen master file (VAMF), antigen, procedure, certification, Certificate of Compliance, marketing authorisation application (MAA)

Current effective version

Guideline on requirements for Vaccine Antigen Master File (VAMF) certification

Adopted Reference Number: EMEA/CPMP/4548/03/Final/Rev 1 Legal effective date: 01/04/2005