Questions and answers for PMF holders
Transfer of PMF-holder - checklist appendix - PMF holders
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
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.