Data requirements for vaccine platform technology master files (PTMF) - Scientific guideline

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

Current effective version

Guideline on data requirements for vaccine platform technology master files (vPTMF)

AdoptedReference Number: EMA/CVMP/IWP/286631/2021Legal effective date: 28/01/2022

Document history

Guideline on data requirements for vaccine platform technology master files (vPTMF)

AdoptedReference Number: EMA/CVMP/IWP/286631/2021Legal effective date: 28/01/2022

Overview of comments received on the draft guideline on data requirements for vaccine platform technology master files (vPTMF) (EMA/CVMP/IWP/283631/2021)

Reference Number: EMA/CVMP/IWP/618280/2021

Draft guideline on data requirements for vaccine platform technology master files (vPTMF)

Draft: consultation closedConsultation dates: 23/07/2021 to 29/10/2021Reference Number: EMA/CVMP/IWP/286631