Concept paper on the need for revision of the guideline on the clinical investigation of plasma derived fibrin sealant/haemostatic products (CPMP/BPWG/1089/00) and the related Core SmPC (CPMP/BPWG/153/00)

Draft

We have adopted this International Scientific Guideline - EMA/CHMP/BPWP/572810/2013.

About this guideline

End of consultation (overseas): 31 August 2014

For information: 1 August 2014

Categories: Clinical efficacy and safety | Blood products (including biotech alternatives)

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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