Stability testing of existing active substances and related finished products - Scientific guideline

This document is an extension of the note for guidance on stability testing of new drug substances and products. It provides guidance on the information to be submitted in registration applications for existing active substances and related finished products. It is applicable to chemical active substances and related finished products, herbal drugs, herbal drug preparations and related herbal medicinal products.

Keywords: Stability, testing, data, chemical active substance, finished product, herbal, specification, storage conditions, re-test period, shelf life, veterinary medicinal product (VMP)