Data requirements for vaccine platform technology master files (PTMF) - Scientific guideline
Table of contents
The main aim of the guideline is to address the type of data to be included in a vaccine platform technology master file (vPTMF). Furthermore, the guideline addresses the omission of information and /or possible reductions on data requirements for subsequent dossier submissions for marketing authorisations (MA) based on a vPTMF after its first evaluation and certification.
Keywords: Vaccine, platform technology, master files, veterinary vaccines, IWP
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Guideline on data requirements for vaccine platform technology master files (vPTMF) (PDF/371.65 KB)
Adopted
First published: 28/01/2022
Legal effective date: 28/01/2022
EMA/CVMP/IWP/286631/2021 -
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Overview of comments received on the draft guideline on data requirements for vaccine platform technology master files (vPTMF) (EMA/CVMP/IWP/283631/2021) (PDF/315.7 KB)
First published: 28/01/2022
EMA/CVMP/IWP/618280/2021 -
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Draft guideline on data requirements for vaccine platform technology master files (vPTMF) (PDF/345.96 KB)
Draft: consultation closed
First published: 23/07/2021
Consultation dates: 23/07/2021 to 29/10/2021
EMA/CVMP/IWP/286631