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).

Download DRAFT Document

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.

TAGS: EMA MAH MA Europe Agency Alerts Regulatory Sciences

Related Articles

People talking around a laptop in a professional business location.
EMA

July 7, 2022

Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics

This guidance document aims to provide interested parties with appropriate guidance on procedural aspects to facilitate the consultation procedure to the European Medicines Agency (EMA) by notified...

Continue reading the blog post
Several COVID-19 vaccine vials lined up on a table.
EMA

June 24, 2022

EMA Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus

8 June 2022 EMA/175959/2021 Rev.2 Human Medicines Division Regulatory and procedural requirements Introduction In order to ensure the continued effectiveness of authorised COVID-19 vaccines, it may...

Continue reading the blog post
3D rendering of a checkmark in a checkbox.
EMA

June 20, 2022

Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)

JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...

Continue reading the blog post