复方产品欧盟指南.pdfVIP

European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use London, 23 June 2008 Doc. Ref. EMEA/HMPC/CHMP/CVMP/214869/2006 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) FINAL GUIDELINE ON QUALITY OF COMBINATION HERBAL MEDICINAL PRODUCTS1 / TRADITIONAL HERBAL MEDICINAL PRODUCTS DRAFT AGREED BY HMPC DRAFTING GROUP ON QUALITY February 2007 ADOPTION BY HMPC FOR RELEASE FOR PUBLIC CONSULTATION 8 March 2007 DRAFT AGREED BY CHMP/CVMP QUALITY WORKING PARTY 7 June 2007 ADOPTION BY CHMP FOR RELEASE FOR PUBLIC CONSULTATION 18 June 2007 ADOPTION BY CVMP FOR RELEASE FOR PUBLIC CONSULTATION 12 July 2007 END OF CONSULTATION (DEADLINE FOR COMMENTS) 31 October 2007 AGREED BY HMPC DRAFTING GROUP ON QUALITY 6 December 2007 ADOPTION BY HMPC 10 January 2008 FINAL AGREED BY CHMP/CVMP QUALITY WORKING PARTY 28 February 2008 ADOPTION BY CVMP 13 March 2008 ADOPTION BY CHMP 24 April 2008 DATE FOR COMING INTO EFFECT