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Guideline on the use of bovine serum in the manufacture of human biological medicinal products

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/457920/2012 rev 1

Last updated

About this guideline

Overseas effective date:  1 December 2013

Replaces: CPMP/BWP/1793/02. Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products. (adopted by TGA 7 September 2004)

Categories: Biologicals  | Finished  product | Adventitious agents safety evaluation viral safety

TGA annotations:

Sponsors should also refer to: TGA Supplementary information on Transmissible Spongiform Encephalopathies (TSEs) regulation.

  • 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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