Procedural advice for vaccine platform technology master file (vPTMF) certification - Procedural Guidance
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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 platform technology master file (vPTMF) by the European Medicines Agency (EMA).
Keywords: Vaccine platform technology master file, vPTMF, certification, procedural advice
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Draft procedural advice for vaccine platform technology master file (vPTMF) certification (PDF/359.9 KB)
Draft: consultation closed
First published: 20/05/2022
Consultation dates: 20/05/2022 to 20/07/2022
EMA/CVMP/184591/2022 -
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Overview of comments received on 'Procedural advice for vaccine platform technology master file (vPTMF) certification' (EMA/CVMP/184591/2022) (PDF/177.11 KB)
First published: 27/01/2023
EMA/CVMP/695453/2022