General information for Plasma Master File (PMF) applicants

  • On June 7 2012 the European Medicines Agency launched a new electronic form for submitting applications for plasma master file (PMF) certificates to the Agency. This replaced the word-format document, Application for an EMA Certificate for a Plasma Master File (PMF) and the document, Variation application – annex to the application form.

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.

How useful was this page?

Add your rating