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Guidance Issuing OfficeCenter for Veterinary Medicine
The following document is a revised version of VICH GL3 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 three regions of the European Union (EU), Japan, and the United States.
The guidance seeks to exemplify the core stability data package for new veterinary drug substances and medicinal products, but leaves sufficient 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 may be used when there are scientifically justifiable reasons.
Specific details of the sampling and testing for particular dosage forms in their proposed container closures are not covered in this guidance.
Further guidance on new dosage forms, medicated premixes, and on biotechnological/biological products can be found in VICH guidances GL4, GL8, and GL17, respectively. Stability testing following first use of the product (e.g., first broaching of a vial) is not covered within this guidance.
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-2006-D-0299.