Plasma Master File (PMF) procedural guidelines
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Guideline on requirements for Plasma Master File (PMF) Certification (PDF/217.44 KB)
Adopted
First published: 26/02/2004
Last updated: 26/02/2004
Legal effective date: 31/03/2004
CPMP/BMP/4663/03 -
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Standard operating procedure for coordinating pre-approval inspections in the context of plasma-master-file certification (PDF/122.84 KB)
Adopted
First published: 21/07/2004
Last updated: 30/04/2013
Legal effective date: 29/04/2013
SOP/INSP/2009
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.
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.