Draft guideline on assessment and control of DNA reactive, mutagenic impurities in veterinary medicines

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Document details

Download document Draft guideline on assessment and control of DNA reactive, mutagenic impurities in veterinary medicines
Reference number EMA/CVMP/SWP/377245/2016
Status draft: consultation open
First published 2017-02-24
Last updated 2017-02-24
Consultation start date 2017-02-24
Consultation end date 2017-08-31
Email address for submissions vet-guidelines@ema.europa.eu

Summary

This guideline focuses on deoxyribonucleic acid (DNA) reactive substances that can potentially cause DNA damage when present at low levels leading to mutations and therefore, potentially causing cancer. Its purpose is to provide a practical framework for identifying, categorising, qualifying and controlling these mutagenic impurities to limit any potential carcinogenic risk. It considers both safety and quality risk management measures to establish levels of impurities with a negligible carcinogenic risk.