Guideline on quality aspects of mRNA vaccines for veterinary use

The aim of the guideline is to outline the information which should be included for mRNA vaccines in the marketing authorisation application (MAA) dossier of veterinary vaccines as required in Section IIIb of Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (repealing Directive 2001/82/EC), referred to as Annex II to Regulation (EU) 2019/6 throughout the document. 
The data requirements and points for consideration for the demonstration of quality of veterinary mRNA vaccines are discussed, and guidance is provided on the information to be included in Part 2 of the MAA dossier. 

Keyword: mRNA, vaccine, development and manufacture, starting materials, active substance, quality, veterinary, finished product

Current version

Draft guideline on quality aspects of mRNA vaccines for veterinary use

Draft: consultation open Consultation dates: 20/02/2026 to 31/08/2026 Summary:

The aim of the guideline is to outline the information which should be included for mRNA vaccines in the marketing authorisation application (MAA) dossier of veterinary vaccines as required in Section IIIb of Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (repealing Directive 2001/82/EC), referred to as Annex II to Regulation (EU) 2019/6 throughout the document. 
The data requirements and points for consideration for the demonstration of quality of veterinary mRNA vaccines are discussed, and guidance is provided on the information to be included in Part 2 of the MAA dossier.

Comments should be provided using our template. The completed comments form should be sent to [e-mail]. 

First version

Draft concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use

Draft: consultation closed Consultation dates: 08/01/2025 to 08/04/2025 Reference Number: EMA/CVMP/IWP/189026/2024 Summary:

This concept paper addresses the need to establish a Guideline on the quality aspects of mRNA vaccines. In the area of human medicinal products, the number applications for clinical trials and marketing authorisations for mRNA containing products significantly increased over the last few years and a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. It is expected that such developments will be seen in the field of vaccines for veterinary use, too.

Comments should be provided using this template. The completed comments form should be sent to [e-mail]