Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products

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Document details

Download document Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products
Reference number EMA/CVMP/QWP/631010/2017
Status draft: consultation open
First published 2017-10-16
Last updated 2017-10-16
Consultation start date 2017-10-16
Consultation end date 2017-11-16
Email address for submissions Vet-Guidelines@ema.europa.eu

Summary

In order to allow time for regulators to elaborate guidance on the appropriate approach for a risk assessment for a veterinary medicinal product, the CVMP has adopted the following measured approach to the implementation of the monograph to existing veterinary products. The phased-in implementation of the risk assessment of elemental impurities in veterinary medicinal products is to be in accordance with the decision tree indicated in this document.