Plasma Master File (PMF) procedural guidelines

Guideline on requirements for Plasma Master File (PMF) Certification

AdoptedLegal effective date: 31/03/2004Reference Number: CPMP/BMP/4663/03

Standard operating procedure for coordinating pre-approval inspections in the context of plasma-master-file certification

AdoptedLegal effective date: 29/04/2013Reference Number: SOP/INSP/2009

Questions and answers for PMF holders

PMF dossier requirements - Questions and answers for PMF holders

AdoptedReference Number: EMA/CHMP/BWP/721411/2022

Transfer of PMF-holder - checklist appendix - PMF holders

Appendix - checklist for the transfer of PMF to a new Holder

Reference Number: EMEA/63698/2007

Note: Transfer of PMF to a new Holder since 01.01.2010 is handled as PMF variation application. Applicants applying for PMF transfer should attach checklist to the variation application.

PMF 2nd step checklist - appendix - MAH

Appendix for a 2nd step Notification (EMA)

Note: PMF 2nd step procedure since 01.01.2010 is handled as MA variation procedure. MAHs should attach 2nd step Appendix to the variation application.

• Variation guideline and PMF list* (see section D and B.V.a)
• European Medicines Agency Post-Authorisation Guidance (Ref. Variations type I)
• European Medicines Agency Post-Authorisation Guidance (Ref. Variations type II)
• Commission guideline on PMF 2nd step
• *Note: Transfer of PMF to a new Holder and 2nd step procedure since 01.01.2010 are handled as variation procedures.