M 4 QCommon Technical Document for the …

European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: EMEA 2006 Reproduction and/or distribution of this Document is authorised for non commercial purposes only provided the EMEA is acknowledged July 2003 CPMP/ICH/2887/99 - quality ICH Topic M 4 Q common Technical Document for the registration of Pharmaceuticals for Human Use - quality Step 5 common Technical Document FOR THE registration OF PHARMACEUTICALS FOR HUMAN USE quality OVERALL SUMMARY OF MODULE 2 AND MODULE 3: quality (CPMP/ICH/2887/99 - quality ) TRANSMISSION TO CPMP July 2000 RELEASE FOR CONSULTATION July 2000 DEADLINE FOR COMMENTS September 2000 TRANSMISSION TO CPMP FOR INFORMATION November 2000 RELEASE FOR INFORMATION November 2000 NUMBERING AND SECTION HEADERS EDITED FOR CONSISTENCY AND USE IN E-CTD AS AGREED BY ICH STEERING COMMITTEE September 2002 TRANSMISSION TO CPMP AND RELEASE FOR INFORMATION February 2003 DATE FOR IMPLEMENTATION July 2003 Note: The sequence of M4 common Technical Document for the registration of Pharmaceuticals for Human Use is: M4 - Organisation of common Technical Document M4 quality - quality o

© emea 2006 3 common technical document for the registration of pharmaceuticals for human use: quality quality overall summary of module 2 module 3: quality

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