Guideline on Active Substance Master File Procedure (2005)

http://www.egagenerics.com/doc/emea_masterfile-0227-02.pdf 2004

http://www.emea.europa.eu/pdfs/human/qwp/022702en.pdf 2005
ASMF = EDMF content (applicant part + restricted part)

CPMP/QWP/227/02 Rev

LOA template