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Guidance Issuing OfficeCenter for Veterinary Medicine
The world can be divided into four climatic zones, I-IV, based on the prevailing annual climatic conditions and the guideline published by the World Health Organization.
This document is an annex to the VICH parent stability guidance, CVM Guidance for Industry (GFI) #73/VICH GL3(R), “Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)” and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration or application submitted within the regions in climatic zones III and IV.
The guidance seeks to exemplify the core stability data package for new veterinary drug substances and medicinal products, but leaves flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative approaches can be used when there are scientifically justifiable reasons.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-4662.