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European Medicines Agency
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40
E-mail: mail@emea.eu.int http://www.emea.eu.int
EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
August 2003
CPMP/ICH/2736/99
ICH Topic Q 1 A (R2)
Stability Testing of new Drug Substances and Products
Step 5
NOTE FOR GUIDANCE ON STABILITY TESTING:
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
(CPMP/ICH/2736/99)
TRANSMISSION OF FIRST REVISION TO CPMP November 1999
RELEASE FOR CONSULTATION November 1999
DEADLINE FOR COMMENTS May 1999
APPROVAL OF FIRST REVISION BY CPMP November 2000
DATE FOR COMING INTO OPERATION June 2001
APPROVAL OF SECOND REVISION BY CPMP February 2003
DATE FOR COMING INTO OPERATION August 2003
