Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

We have adopted this International Scientific Guideline - EMA/CHMP/CVMP/SWP/169430/2012

Last updated

15 July 2024

About this guideline

Adopted by the TGA: 8 June 2023

Overseas effective date: 1 June 2015

Categories: Non-clinical | Non-clinical development

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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