Plasma Master File (PMF) submissions
HumanRegulatory and procedural guidanceResearch and development
When shall I submit my application? What is the timetable for my procedure?
The appropriate time and planning of submission and the timetable for assessment of applications is important for applicants, the European Medicines Agency, CHMP members and experts for a better and efficient working plan.
The submission deadlines and full procedural timetables are published as a generic calendar and are for the information and use of Applicant/PMF Holder, the European Medicines Agency, CHMP members and assessment teams. The published timetables identify the submission, start and finish dates of the procedures as well as other interim dates/milestones that occur during the procedure.
Timetables are classified under 90, 60 or 30 day evaluation procedure and individual links are provided on this page. The initial PMF certification procedure is run on a 90 day evaluation timetable. The timetable for annual update is 60 day (or 90 day) and is decided in consultation with the coordinator. Depending on the extent of the responses, their evaluation will follow a 30 or 60 day timetable.
The submission/start/CHMP dates are generally fixed; other dates may be subject to adjustments until the CHMP Scientific committee proceeds to their adoption for every individual application.
At the start of the procedure, the adopted final timetable will be formally notified in writing to applicants.
Submission deadlines / Timetables:
- CHMP Meetings (see question 25a)
Additional information on use of timetable:
“Teleconference” is set up between Coordinators and the European Medicines Agency staff to discuss and critically analyse the different objections and concerns raised in the Coordinators' Evaluation Report and BWP comments.
“Preliminary Evaluation Reports” are circulated to the Applicants. This report sets out only the preliminary conclusions of the Coordinator. This report in no way binds the BWP/CHMP and is sent at this point for information only.
Interim dates/milestones (BWP Comments, Updated Evaluation Reports and teleconference outcomes) are not made available to applicant during the procedure; however, they are reflected in the Evaluation Report as adopted by the CHMP. This adopted Evaluation Report will be sent to the Applicant/PMF Holder.