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

Scientific guidelineHumanScientific guidelines

Maltese is available via eTranslation, the European Commission's machine translation service.

Translate to Maltese | Important information about machine translation

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:

English (EN) (101.58 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

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:

English (EN) (101.58 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Draft guideline on medicinal gases: pharmaceutical documentation - Revision 1

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

English (EN) (112.79 KB - PDF)

Ippubblikat għall-ewwel darba: Aġġornata l-aħħar:
Ara

Share this page