VICH GL10 Impurities in new veterinary drug substances - Scientific guideline

This document provides guidance for registration applications on the content and qualification of impurities in new drug substances intended to be used for new veterinary medicinal products. It applies to the substances produced by chemical syntheses and not previously registered in a region or member state.

Keywords: Drug substance, impurities, organic, inorganic, solvents, specifications, VICH, veterinary medicial product (VMP)

Current effective version

VICH GL10: Impurities in new veterinary drug substances - Step 7 (after revision at step 9)

Adopted Reference Number: EMEA/CVMP/VICH/837/99-Rev.1 Legal effective date: 01/01/2008

Document history

VICH GL10: Impurities in new veterinary drug substances - Revision at step 9 for consultation at step 4

Draft: consultation closed Reference Number: CVMP/VICH/837/99-Rev.1