International scientific guideline: Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products

About this guideline

Overseas effective date: 1 Apr 2014

Replaces: EMEA 410/01 Rev 2 (adopted by the TGA 20 September 2005)

Categories: Biological medicines | Drug product | Transmissible spongiform encephalopathies (TSE) (animal and human)

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TGA annotations

This EU Guideline should be interpreted in the context of the TGA Supplementary information on Transmissible Spongiform Encephalopathies (TSEs) regulation.

Adoption of this EU Guideline is in line with current pharmacopoeial standards.

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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.