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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Guideline on Control of Impurities of Pharmacopoeial Substances (CPMP/QWP/1529/04)
Short Title:CPMP/QWP/1529/04
Internet:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002924.pdf
Origin/Publisher:EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
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.
Document Type:Guideline