Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases)
Table of contents
| Keywords | Medicinal gases |
| Description | 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. |
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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 -
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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