EMA: Procedural advice for vaccine platform technology master 5 file (vPTMF) certification (DRAFT)

June 2, 2022

Several vials of COVID-19 vaccines lined up on a table.

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). The detailed scientific requirements for an application for veterinary vPTMF certification are described in Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council and in the Guideline on data requirements for vaccine platform technology master files (vPTMF) (EMA/CVMP/IWP/286631/2021).

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TAGS: EMA MAH MA Europe Agency Alerts Regulatory Sciences

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