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Questions and answers on implementation of risk-based prevention of cross-contamination in production

And ‘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/246844/2018

Last updated

About this guideline

Adopted by the TGA: 8 June 2023

Overseas effective date: 19 April 2018

Note:  To be read in conjunction with the Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012)

Categories:  Non-clinical | Non-clinical development 

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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For more information see International scientific guidelines adopted in Australia.

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