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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.