Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances - Scientific guideline

The aim of this guideline is to define minimum data requirements for the demonstration of quality, safety and efficacy of immunological veterinary medicinal products (IVMPs) for applications submitted under Article 25 of Regulation (EU) 2019/6.

This guideline replaces the CVMP related guidelines (“Guideline on requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue” (EMEA/CVMP/IWP/37267/2008) and the “Guideline on requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza” (EMEA/CVMP/IWP/222624/2006)).

Keywords: Immunological veterinary medicinal products, veterinary vaccines, exceptional circumstances, new veterinary regulation, IWP

Current version - effective from 28/01/2022

Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances

Adopted Reference Number: EMA/CVMP/IWP/251947/2021 Legal effective date: 28/01/2022

Document history

Overview of comments received on the draft guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances (EMA/CVMP/IWP/251947/2021)

Reference Number: EMA/CVMP/IWP/618299/2021

Draft guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances

Draft: consultation closed Consultation dates: 23/07/2021 to 29/10/2021 Reference Number: EMA/CVMP/IWP/299554/2021

Draft concept paper for the development of a guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances

Draft: consultation closed Consultation dates: 29/01/2021 to 31/03/2021 Reference Number: EMA/CVMP/IWP/630533/2020

• Superseded guideline on the requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue
• Superseded guideline on the requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza