Requirements for vaccine antigen master file certification

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Current effective version

Revision 1 - Adopted guideline

Reference numberCPMP/4548/03/Final/Rev. 1
Published17/03/2005
Effective from01/04/2005
KeywordsVaccine 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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