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Guideline on epidemiological data on blood transmissible infections
[PDF, 164.73 KB]
About this guideline
Overseas effective date: 1 March 2011
Replaces: EMEA/CPMP/BWP/125/04 Guideline on Epidemiological Data on Blood Transmissible Infections (Adopted by TGA 19 September 2008) and Concept paper EMEA/CHMP/BWP/505885/2008 on this topic (provided for information 14 April 2009)
Note: Appendices to this guideline can be accessed at Appendices to Guideline on epidemiological data on blood transmissible infections (EMA/CHMP/BWP/174129/2009)
Categories: Biological medicines | Drug substance | Plasma master file
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.