Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version

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Document details

Download document Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version
Reference number EMA/CVMP/VICH/335918/2016
Status draft: consultation open
First published 2018-07-27
Last updated 2018-07-27
Consultation start date 2018-07-27
Consultation end date 2018-12-31
Email address for submissions vet-guidelines@ema.europa.eu

Summary

The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.