Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Scientific guideline
Table of contents
This document specifies the elements relating to the quality of medicinal gases in the context of compiling the pharmaceutical documentation for Module III (Quality) of the dossier.
Keywords: Medicinal gases
-
List item
Guideline on medicinal gases: Pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Revision 1 (PDF/101.58 KB)
Adopted
First published: 09/07/2008
Last updated: 09/07/2008
Legal effective date: 01/11/2008
CPMP/QWP/1719/00 Rev 1 -
List item
Draft guideline on medicinal gases: pharmaceutical documentation - Revision 1 (PDF/112.79 KB)
Draft: consultation closed
First published: 05/10/2007
Last updated: 05/10/2007
CPMP/QWP/1719/00 Rev 1