International scientific guideline: Points to consider on the need for assessment of reproductive toxicity of human insulin analogues

About this guideline

Overseas effective date: 5 March 2003

Categories: Nonclinical | Toxicology | Reproductive and developmental toxicity

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For more information see International scientific guidelines adopted in Australia.

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.