International scientific guideline: Note for Guidance on Plasma-Derived Medicinal Products

About this guideline

Overseas effective date: 30 Aug 2001

Categories: Biological medicines | Drug substance | Plasma-derived medicinal products

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TGA annotations

Annex V (CPMP/BWP/390/97) of Guidance CPMP/BWP/269/95 Rev 3 remains current.

Further information: Replaced by: EMA/CHMP/BWP/706271/2010

For more information see International scientific guidelines adopted in Australia.

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.