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Guideline on production and quality control of animal immunoglobulins and immunosera for human use

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/3354/1999 rev.1 

Last updated

About this guideline

Overseas effective date: 1 September 2016

Replaces: CPMP/BWP/3354/99 Note for Guidance on the Production and Quality Control of Animal Immunoglobulins and Immunosera for Human Use (adopted by TGA 7 September 2004)

Categories: Biologicals | Active substance | Manufacture, characterisation and control of the active substance

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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