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Guideline on Active Substance Master File Procedure
www.ema.europa.euThe corrections introduced to this guideline aim to support the Working Group on Active Substance Master File Procedures in their initiatives to improve the ASMF ...
Guideline on Active Substance Master File Procedure
www.ema.europa.eu• Annex 3, detailing the need to declare the salt form, water content and grade of the active substance, as applicable. CHMP/QWP/227/02 Rev 3/Corr Page 2/22