Data requirements for vaccine antigen master files (VAMF) - Scientific guideline

This guideline address the data to be included in a vaccine antigen master file (VAMF) for veterinary vaccines.

Keywords: Vaccine antigen master file, VAMF

Current effective version

Guideline on data requirements for vaccine antigen master files (VAMF)

AdoptedReference Number: EMA/CVMP/IWP/258755/2021Legal effective date: 28/01/2022

English (EN) (286.31 KB - PDF)

First published: 28/01/2022

Guideline on data requirements for vaccine antigen master files (VAMF)

AdoptedReference Number: EMA/CVMP/IWP/258755/2021Legal effective date: 28/01/2022

English (EN) (286.31 KB - PDF)

First published: 28/01/2022

Draft guideline on data requirements for vaccine antigen master files (VAMF)

Draft: consultation closedConsultation dates: 25/06/2021 to 30/09/2021Reference Number: EMA/CVMP/IWP/258755/2021

English (EN) (262.21 KB - PDF)

First published: 25/06/2021

Overview of comments received on “Guideline on data requirements for vaccine antigen master files (VAMF)” (EMA/CVMP/IWP/258755/2021)

Reference Number: EMA/CVMP/IWP/544053/2021

English (EN) (275.78 KB - PDF)

First published: 28/01/2022

Draft concept paper for the development of a guideline on data requirements for vaccine antigen master files (VAMF)

Draft: consultation closedConsultation dates: 29/01/2021 to 31/03/2021Reference Number: EMA/CVMP/IWP/674640/2020

English (EN) (211.41 KB - PDF)

First published: 29/01/2021