VICH GL3 Stability testing of new veterinary drug substances and medicinal products - Scientific guideline
Table of contents
This document addresses the information to be submitted in registration applications for new molecular entities and associated medicinal products. It does not currently seek to cover the information to be submitted for abbreviated or abridged applications, variations, or clinical trial applications.
Keywords: Stability, stability testing, stability data, chemical active substance, finished product, specification, storage conditions, VICH, veterinary medicinal product (VMP)
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VICH GL3: Stability testing of new veterinary drug substances and medicinal products - Step 7 (after revision at step 9) (PDF/158.48 KB)
Adopted
First published: 19/02/2007
Last updated: 19/02/2007
Legal effective date: 01/01/2008
EMEA/CVMP/VICH/899/99-Rev.1 -
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VICH GL3: Stability testing of new veterinary drug substances and medicinal products - Revision at step 9 for consultation at step 3 (PDF/188.88 KB)
Draft: consultation closed
First published: 05/10/2005
Last updated: 05/10/2005
EMEA/CVMP/VICH/899/99-Rev.1