Eudralex Volume 3 Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “substances for pharmaceutical use” and general chapter “control of impurities in substances for pharmace
Title:
Eudralex Volume 3 Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “substances for pharmaceutical use” and general chapter “control of impurities in substances for pharmace
Short Title:
EMA/CVMP/QWP/907965/2022
Origin/Publisher:
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.