Guideline on risk assessment of medicinal products on human reproduction and lactation: From data to labelling

We have adopted this International Scientific Guideline - EMEA/CHMP/203927/2005

Last updated

15 July 2024

About this guideline

Overseas effective date: 1 January 2009

Categories: Non-clinical | Toxicology

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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