Templates - DCP (AR/Comments)
In order to view some of the documents on this website you need Acrobat Reader
(click here to download)
Non Clinical / Clinical AR for Generics - MRP & DCP [.dot]
Last update December 2011
D70 Preliminary AR
Overview [.dot]
Last update January 2012
Quality [.dot]
Last update October 2011
Active Substance Master File (ASMF) AR [.dot]
Last updated October 2011
Non-clinical [.dot]
Last updated December 2011
Clinical [.dot]
Last updated December 2011
D120 finalisation (opt.) .doc / .dot
D120 Draft AR
Overview [.dot]
Last update July 2009
Non-clinical [.dot]
Clinical [.dot]
D120/D180 Quality AR .doc / .dot
D150 finalisation (opt.) .doc / .dot
D180 RMS report to CMDh .doc / .dot