Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Scientific guideline

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

Current effective version

Guideline on medicinal gases: Pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Revision 1

Adopted Reference Number: CPMP/QWP/1719/00 Rev 1 Legal effective date: 01/11/2008

Document history

Guideline on medicinal gases: Pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Revision 1

Adopted Reference Number: CPMP/QWP/1719/00 Rev 1 Legal effective date: 01/11/2008

Draft guideline on medicinal gases: pharmaceutical documentation - Revision 1

Draft: consultation closed Reference Number: CPMP/QWP/1719/00 Rev 1