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)
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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