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

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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)

Pirmą kartą paskelbta: Paskutinį kartą atnaujinta:
Rodyti

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)

Pirmą kartą paskelbta: Paskutinį kartą atnaujinta:
Rodyti

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)

Pirmą kartą paskelbta: Paskutinį kartą atnaujinta:
Rodyti

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