Scientific data requirements for plasma master file - Scientific guideline

This 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.

Keywords: Plasma master file, annual update, dossier data requirements, plasma master file (PMF)

Current effective version

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

AdoptedLegal effective date: 01/06/2007Reference Number: EMEA/CHMP/BWP/3794/03 Rev.1

Annexes to guideline on the scientific data requirements for a plasma master file (PMF) Revision 1

AdoptedReference Number: EMEA/CHMP/BWP/3794/03 Rev1 Ann.