Requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) - Scientific guideline

This document outlines items to be considered and the data requirements in relation to marketing authorization applications for combined vaccines and applications where an association between two or more different immunological veterinary medicinal products is claimed by the applicant.

Keywords: Combined vaccines, immunological veterinary medicinal product (IVMP)

Current version

Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) - Revision 1

Draft: consultation closed Consultation dates: 14/01/2026 to 22/05/2026 Reference Number: EMA/CVMP/IWP/365787/2025-Rev.1 Summary:

This guideline replaces the current version of the Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) (EMA/CVMP/IWP/594618/2010). The guideline was revised in order to adapt legal references to the current legislation and reflect the experience that was gained with the guideline since it is in force. In addition, new approaches in vaccine development and alternative approaches to assess the absence of immunological interference in the associated use of vaccines are considered in the revision. This information is also included in the guideline. 

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

Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

Adopted Reference Number: EMA/CVMP/IWP/594618/2010

Concept paper for the revision of the Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

Draft: consultation closed Consultation dates: 13/12/2024 to 13/03/2025 Reference Number: EMA/CVMP/IWP/188413/2024

Document history - First version

Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

Adopted Reference Number: EMA/CVMP/IWP/594618/2010

Overview of comments received on guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products

Reference Number: EMA/CVMP/IWP/441123/2013

Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

Draft: consultation closed Consultation dates: 15/11/2012 to 15/01/2013 Reference Number: EMA/CVMP/IWP/594618/2010 Summary:

This document provides guidance on the data requirements to support authorisation of combined vaccines and a claim for the use of two or more IVMPs, each with its own separate marketing authorisation, in association with one another. This term was introduced during the amendment of Title II to Annex I to Directive 2001/82/EC, and there is a need to define the items covered by the term association and identify the scientific data which are necessary to justify the use of an association.

Superseded document

Guideline on requirements for concurrent administration of immunological veterinary medicinal products

Adopted Reference Number: EMEA/CVMP/550/02-FINAL Legal effective date: 15/04/2004

Superseded document

Concept paper on the need to revise the note for guidance on requirements for combined vaccines CVMP/IWP/52/97-FINAL

Reference Number: EMEA/CVMP/018/04-CONS.

Note for guidance: Requirements for combined veterinary vaccines

Adopted Reference Number: CVMP/IWP/52/97-FINAL Legal effective date: 01/01/2001