Transcription of Guideline on stability testing for variations to an MA
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Guideline on stability testing for variations to an MA
European Medicines Agency Inspections Public 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: @EMEA 2005 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged London, 19 May 2005 CPMP/QWP/576/96 Rev 1 EMEA/CVMP/373/04 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) Guideline ON stability testing FOR APPLICATIONS FOR variations TO A MARKETING AUTHORISATION DRAFT AGREED BY QUALITY WORKING PARTY October 2003/ April 2004 (joint)
cpmp/qwp/576/96 rev 1 emea/cvmp/373/04 emea 2005 3/6 guideline on stability testing for applications for variations to a marketing authorisation
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