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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].

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For more information see International scientific guidelines adopted in Australia.

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