Scientific data requirements for plasma master file - Scientific guideline

This guidance 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, regulation update, standards of quality and safety for substances of human origin, collection and testing of human blood and blood components, donor eligibility, inspection of centres/establishments, traceability

Current version

Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes

Draft: consultation openConsultation dates: 31/03/2025 to 30/06/2025Reference Number: EMA/CHMP/BWP/91140/2025Summary:

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

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

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

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.