Certification procedure

NfG CHMP/QWP/297/97 rev. 1 corr
“Summary of requirements for active substances
in the quality part of the dossier”
2.1 Certificate of suitability
Since this procedure requires a Ph. Eur. monograph, it is used for
existing substances and the guideline states : “ where applicable,
option 2.1 has the advantage of generally avoiding any
subsequent reassessment ”
2.2 Active substance Master File (ASMF)
2.3 Full details of manufacture in licence application
Since these procedures do not require a Ph. Eur. monograph they
can be used for new substances;
but may also be used for existing substances.
Andrew McMath 29/01/10 ©2010 EDQM, Council of Europe, All rights reserved