Docket Number:
FDA-2018-D-4662
Issued by:
Guidance Issuing Office
Center 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.

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