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

• Superseded guideline on the requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue
• Superseded guideline on the requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza