Transcription of GUIDELINE ON SPECIFICATONS: TEST PROCEDURES …
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GUIDELINE ON SPECIFICATONS: TEST PROCEDURES …
European Medicines Agency Inspections Public 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 30 March 2006 CPMP/QWP/2820/00 Rev 1 EMEA/CVMP/815/00 Rev 1 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR HERBAL SUBSTANCES1, HERBAL PREPARATIONS2 AND HERBAL MEDICINAL PRODUCTS3/TRADITIONAL HERBAL MEDICINAL PRODUCTS DISCUSSION AT THE HMPC January March 2005 DRAFT AGREED BY QUALITY WORKING PARTY April 2005 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 26 May 2005 ADOPTION BY CVMP FOR RELEASE FOR CONSULTATION 15 June 2005 END OF CONSULTATION (DEADLINE FOR COMMENTS) 15 September 2005 DISCUSSION AT THE HMPC November 2005 January 2006 ADOPTION BY THE HMPC 22 January 2006 AGREED BY QUALITY WORKING PARTY February 2006 ADOPTION BY CHMP 23 March 2006 1 The term herbal substance should be considered as equivalent to the term herbal drug
European Medicines Agency Inspections Public 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51
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