Scientific data requirements for a vaccine antigen master file - Scientific guideline

This document describes scientific requirements for the submission, evaluation and certification of vaccine antigen master file (VAMF). It aims to facilitate the implementation of Annex I of Directive 2001/83/EC, as amended. 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, quality scientific data, certification, Certificate of Compliance, marketing authorisation application (MAA)

Current version

Guideline on the scientific data requirements for a vaccine antigen master file (VAMF)

Adopted Reference Number: EMEA/CPMP/BWP/3734/03 Legal effective date: 01/03/2004