VICH GL43 Target animal safety: pharmaceuticals - Scientific guideline

This document provides recommendations regarding target animal safety (TAS) evaluation for regulatory submission of an investigational veterinary pharmaceutical product (IVPP), which is appropriate for determining the safety of an IVPP in the target animal. It aims to facilitate the mutual acceptance of TAS data by the regulatory authorities in the VICH regions.

Keywords: Target animal safety (TAS), investigational veterinary pharmaceutical product (IVPP), VICH, veterinary medicinal product (VMP)

Current effective version

VICH GL43: Target animal safety for veterinary pharmaceutical products - Step 7

Adopted Reference Number: EMEA/CVMP/VICH/393388/2006 Legal effective date: 01/07/2009

Document history

VICH GL43: Target animal safety for pharmaceuticals - Step 4

Draft: consultation closed Reference Number: EMEA/CVMP/VICH/393388/2006