VICH GL3 Stability testing of new veterinary drug substances and medicinal products - Scientific guideline

VeterinaryScientific guidelines

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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)

Document history - Revision 1 (current version)

VICH GL3: Stability testing of new veterinary drug substances and medicinal products - Step 7 (after revision at step 9)

Adopted Reference Number: EMEA/CVMP/VICH/899/99-Rev.1 Legal effective date:

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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

Draft: consultation closed Reference Number: EMEA/CVMP/VICH/899/99-Rev.1

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