Scientific data requirements for a vaccine antigen master file

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Current effective version

Adopted guideline

Reference numberCPMP/BWP/3734/03
Published15/12/2003
Effective from01/03/2004
KeywordsVaccine antigen master file (VAMF),  antigen, quality scientific data, certification, Certificate of Compliance, marketing authoristation application (MAA)
Description

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.


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