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

Current version

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

Reference Number: EMA/CVMP/184591/2022 Rev.1

English (EN) (389.43 KB - PDF)

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Document history

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

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

English (EN) (359.9 KB - PDF)

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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

English (EN) (177.11 KB - PDF)

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