Plasma Master File (PMF) procedural guidelines

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.

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