Scientific data requirements for plasma master file

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Current effective version

Revision 1 - Adopted guideline

Annexes

Reference numberCHMP/BWP/3794/03 Rev. 1
Published15/11/2006
Effective from01/06/2007
KeywordsPlasma master file, annual update, dossier data requirements, plasma master file (PMF)
DescriptionThis document describes the structure and scientific data required on plasma, from collection to plasma pool to be submitted in a plasma master file (PMF) or included in a marketing authorisation dossier whenever the PMF certification scheme is not followed.


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