Requirements for vaccine antigen master file certification

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference number CPMP/4548/03/Final/Rev. 1
Published 17/03/2005
Effective from 01/04/2005
Keywords Vaccine antigen master file (VAMF), antigen, procedure, certification, Certificate of Compliance, marketing authoristation application (MAA)
Description

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.


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