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Guideline on non-clinical local tolerance testing of medicinal products

We have adopted this International Scientific Guideline - CHMP/SWP/2145/2000 Rev. 1, Corr. 1* 

Last updated

About this guideline

Overseas effective date: 1 May 2016

Replaces:  CPMP/SWP/2145/00 Note for Guidance on Non-Clinical Local Tolerance Testing of Medicinal Products

Categories: Non-clinical | Toxicology | Local tolerance

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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