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

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.