CMDh BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE - Rev 16 and Release date is 26th March 2012.

Heads of Medicines Agencies (CMDh) has released updated version (ver 16) BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE guidance on 26th March 2012.

Please use the below mentioned link to find the updated guidance.

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_094_2003_Rev16_-_clean_2012_03.pdf