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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
June 2005
CPMP/ICH/5716/03
ICH Topic E 2 E
Pharmacovigilance Planning (Pvp)
Step 5
NOTE FOR GUIDANCE ON PLANNING PHARMACOVIGILANCE ACTIVITIES
(CPMP/ICH/5716/03)
TRANSMISSION TO CHMP November 2003
TRANSMISSION TO INTERESTED PARTIES November 2003
DEADLINE FOR COMMENTS May 2004
FINAL APPROVAL BY CHMP December 2004
DATE FOR COMING INTO OPERATION June 2005
