EMA report on the implementation of the possibility for waiving the target animal batch safety test for immunological veterinary medicinal products in the European Union

This paper addresses the efforts to waive the target animal batch safety tests (TABST) among European marketing authorisation holders (MAHs) for veterinary vaccines. MAHs argue that the current process to generate documentation is time consuming and needs significant resources. This paper discusses the main issues raised by the companies and gives an overview of the current situation regarding the number of products for which a waiver of the TABST was obtained.