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COMMITTEE FOR MEDICINAL PRODUCTS FOR …

European Medicines Agency Veterinary Medicines and Inspections 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95 E-mail: European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged London, 5 August 2008 EMEA/CVMP/QWP/846 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON STABILITY TESTING: STABILITY TESTING OF EXISTING ACTIVE SUBSTANCES AND RELATED FINISHED PRODUCTS DRAFT AGREED BY QUALITY WORKING PARTY (QWP) September 2007 ADOPTION BY CVMP FOR RELEASE FOR CONSULTATION October 2007 END OF CONSULTATION (DEADLINE FOR COMMENTS) April 2008 AGREED BY QUALITY WORKING PARTY (QWP) June 2008 ADOPTION BY CVMP July 2008 DATE FOR COMING INTO EFFECT September 2011 This guideline replaces an earlier version of this guideline, EMEA/CVMP/846/99.

Revision History . The guideline EMEA/CVMP/846/99 was revised to be brought in line with the requirements of the Note for Guidance on Stability Testing of New Veterinary Drug Substances and Medicinal Products

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