Procedural advice for veterinary vaccine antigen master file (VAMF) certification - Procedural Guidance

This document is intended to provide advice to marketing authorisation (MA) applicants and marketing authorisation holders (MAHs) on issues associated with the submission, evaluation, certification and use of a veterinary vaccine antigen master file (VAMF) by the European Medicines Agency (EMA).

Keywords: Vaccine antigen master file, VAMF, certification, procedural advice

Current version

Procedural advice for veterinary vaccine antigen master file (VAMF) certification

Adopted Reference Number: EMA/CVMP/127488/2021 Rev.1

Document history

Procedural advice for veterinary vaccine antigen master file (VAMF) certification - draft

Draft: consultation closed Consultation dates: 12/11/2021 to 12/01/2022 Reference Number: EMA/127488/2021

Overview of comments received on 'Procedural advice for veterinary vaccine antigen master file (VAMF) certification’ (EMA/CVMP/127488/2021)

Reference Number: EMA/CVMP/45571/2022