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

We have adopted this International Scientific Guideline - CPMP/QWP/1719/00 Rev 1.

Last updated

4 June 2024

About this guideline

Overseas effective date: 1 November 2008

Replaces: CPMP/QWP/1719/00 (adopted by TGA 12 March 2003)

Categories: Non-clinical | Toxicology | Specific types of products, and Quality | Specific types of products

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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