Transcription of Note for guidance on start of shelf-life of the finished ...
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Note for guidance on start of shelf-life of the finished ...
The European Agency for the Evaluation of Medicinal Products7 Westferry Circus, Canary Wharf, London, E14 4HB, UKTel (44-20-7) 418 8400 Fax (44-20-7) 418 85 95E-mail: 2001 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledgedLondon, 31 May 2001 CPMP/QWP/072/96 EMEA/CVMP/453/01 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS(CPMP)COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS(CVMP)NOTE FOR guidance ON start OF shelf-life OF THEFINISHED DOSAGE FORM(ANNEX TO NOTE FOR guidance ON THE MANUFACTURE OFTHE finished DOSAGE FORM )DISCUSSION IN THE QUALITY WORKING PARTYOct. 1995 February 1996 TRANSMISSION TO THE CPMPJune 1996 RELEASE FOR CONSULTATIONJune 1996 DEADLINE FOR COMMENTSD ecember 1996 Development of guideline postponed pending decision on inclusion in GMP guidance orpublication as Quality guidelineADOPTION BY CPMP/CVMPMay 2001 DATEFORCOMINGINTOOPERATIOND ecember 2001 CPMP/072/96 EMEA/CVMP/453/01 EMEA 20011/1 NOTE FOR guidance ON S
finished dosage form (annex to note for guidance on the manufacture of the finished dosage form ) discussion in the quality working party oct. 1995 february 1996 transmission to the cpmp june 1996 release for consultation june 1996 deadline for comments december 1996
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