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Guideline on the scientific data requirements for a plasma master file (PMF) revision 1

We have adopted this International Scientific Guideline - EMEA/CHMP/BWP/3794/03 Rev.1 

Last updated

About this guideline

Overseas effective date:  1 June 2007

Categories: Biologicals | Active substance | Plasma master file

TGA annotations:

Refer to the EMA website at Biologicals: Drug substance Plasma master file- ext for a MS Word copy of Annexes to EMEA/CHMP/BWP/3794/03 Rev.1 [Annexes to Guideline on the Scientific Data Requirements for a Plasma Master file (PMF) Revision 1].

  • 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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