VICH GL11 Impurities in new veterinary medicinal products - Scientific guideline

This document provides guidance for registration applications on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesised new drug substances not previously registered in a region or member state.

Keywords: Impurities, reporting, control, qualification, specifications, VICH, veterinary medicinal product (VMP)

Current effective version

VICH GL11: Impurities in new veterinary medicinal products - Step 7 (after revision at step 9)

Adopted Reference Number: EMEA/CVMP/VICH/838/99-Rev.1 Legal effective date: 01/01/2008

Document history

VICH GL11: Impurities in new veterinary medicinal products - Revision at step 9 for consultation at step 4

Draft: consultation closed Reference Number: CVMP/VICH/838/99-Rev.1