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Eudralex Volume 3 Guideline on Control of Impurities of Pharmacopoeial Substances (CPMP/QWP/1529/04)
EMA
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Document Type:
Guideline
Content:
This Guideline describes how European Licensing Authorities should react when they are faced during an application for a Marketing Authorisation to a monograph not complying with the state of the art.