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.

Eudralex Volume 3 Guideline on the Limits of genotoxic impurities (CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006)

Short Title:

EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Document Type:
This Guideline describes a general framework and practical approaches on how to deal with genotoxic impurities in new active substances.

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