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

We have adopted this International Scientific Guideline - EMEA/410/01 Rev. 3 

Last updated

About this guideline

Overseas effective date: 1 July 2011

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

Categories: Biologicals | Finished product | Transmissible spongiform encephalopathies (TSEs) (animal and human)

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.

 

  • 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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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