Procedural advice for vaccine platform technology master file (vPTMF) certification - Procedural Guidance

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

Current version

Procedural advice for vaccine platform technology master file (vPTMF) certification

Reference Number: EMA/CVMP/184591/2022

Document history

Draft procedural advice for vaccine platform technology master file (vPTMF) certification

Draft: consultation closed Consultation dates: 20/05/2022 to 20/07/2022 Reference Number: EMA/CVMP/184591/2022

Overview of comments received on 'Procedural advice for vaccine platform technology master file (vPTMF) certification' (EMA/CVMP/184591/2022)

Reference Number: EMA/CVMP/695453/2022