Note on the removal of the target animal batch safetytest (TABST) from European Pharmacopoeia monographs - Scientific guideline

The requirement for the target animal batch safety test (TABST) for veterinary vaccines was withdrawn from the European Pharmacopoeia, effective as of April 2013. As the test is no longer required, the guideline on data requirements for removing the target animal batch safety test for immunological veterinary medicinal products in the EU (EMA/CVMP/IWP/810769/2011) no longer applies.

Keywords: Target animal batch safety test, European Pharmacopoeia, monograph

Current effective version

Note on the removal of the target animal batch safety test (TABST) from European Pharmacopoeia monographs

Reference Number: EMA/CVMP/IWP/107173/2015 Summary:

The requirement for the target animal batch safety test (TABST) for veterinary vaccines was withdrawn from the European Pharmacopoeia, effective as of April 2013. As the test is no longer required, the Guideline on data requirements for removing the target animal batch safety test for immunological veterinary medicinal products in the EU (EMA/CVMP/IWP/810769/2011) no longer applies.

Document history - Superseded documents

Guideline on data requirements for removing the target animal batch safety test for immunological veterinary medicinal products in the European Union

Adopted Consultation dates: 10/01/2012 to 31/07/2012 Reference Number: EMA/CVMP/IWP/810769/2011 Legal effective date: 31/01/2012 Summary:

This guideline outlines the data requirements to be submitted by the marketing authorisation holder in order to waive the target animal batch safety test for the release of a batch of this product onto the market.

Position paper on data requirements for removing the target animal batch safety test for immunological veterinary medicinal products in the European Union

Adopted Reference Number: EMEA/CVMP/865/03/Final Legal effective date: 15/01/2005