This document summarizes the key points of a plasma master file (PMF). A PMF contains all required scientific data on the quality and safety of human plasma used to manufacture medicines, medical devices, and investigational products. It was introduced by the European Union in 2003 to simplify regulatory submissions and ensure consistent evaluation of plasma quality across countries. The certification process involves submitting an application to the European Medicines Agency, which appoints coordinators to evaluate the PMF and issue a certificate valid throughout the EU if compliance is demonstrated. Changes to plasma or products listed in the PMF require recertification through this centralized procedure.

1. PLASMA MASTER FILE
PRESENTED BY : SANJAY
M.PHARM 2nd SEM
DEPARMEENT OF
PHARMACEUTICAL
SCIENCE, ROHTAK
SUBMITTED TO:
MRS. POONAM
YADAV
Assistance prof.
of
Pharmaceutics

2. CONTENTS
• INTRODUCTION
• PRINCILES OF PMF
• CERTIFICATION OF PMF
• REQUIREMENTS FOR INITIAL APPLICATION FOR CERTIFICATION
• CHANGES TO THE CONTENTS OF A PMF

3. WHAT IS PMF
It is a compilation of all the required scientific data on the quality and
safety of human plasma relevant to the medicines, medical devices and
investigational products that use human plasma in their manufacture.
In June 2003, this concept was introduced by European legislation
However this document is intended to provide guidance on the
submission, evaluation & certification of PMF

4. DIRECTIVE 2001/83/EC 25 JUNE 2003 DIRECTIVE 2003/63/EC
PRINCIPLES OF PMF
The aim of the PMF is to just simply the tasks of MAH & Competent
authorities:-
 reduces number of dossier submission & data evaluation for the
same plasma
 Ensure consistency throughout EC

5. ADMINISTRATIVE INFORMATION
• An application form for each EMEA
• A list of medicinal product to which PMF is applied
• Information of pending approval will be given
• The period of data collection should be specified
EXPERT STATEMENT SHOULD BE PROVIDED IN PMF

6. CERTIFICATION PROCEDURE
• 1st step:- it is similar to centralized procedure which results in a
certificate of compliance to community legislation issued by EMEA . It
is valid throughout EU
• 2nd step:-the competent authority who will or has granted the MA shall
be responsible for certification or re-certification of the PMF

7. Note :- if the applicant chooses the community PMF certification system, all
variation will be submitted through the same certification system
Certificate of compliance
(valid throughout the European country)
1st step
PMF certification
Product A
Using
Plasma X
Product C
Using
Plasma X
Product B
Using
Plasma X
2nd step
Impact on the
medicinal product
Concerned medicinal product in
which plasma X is used

8. NOTE FOR APPLICANTS:- NO VARIATION WILL BE ENTERTAINED
DURING THE CERTIFICATION PROCEDURE
Letter of intent to EMEA
 The applicant should inform the EMEA 2-3 months prior about the
certification
 Should specify the intended submission date
 The appropriate trigger for submission
 The applicant should also propose co-ordinators in their letter of intent. Then
co-ordinators will be responsible for the evaluation of PMF on behalf of
EMEA

9. APPOINTMENT OF CO-ORDINATORS
EMEA ISSUE A LIST OF PMF CO-ORDINATOR
• Two co-ordinators will be appointed by CPMP in consultation with
BWP. After this the appointment will be notified to the applicant
SUBMISSION AND VALIDATION
• The monthly deadline for submission of PMF application will be
published on EMEA website
• What documents are required are also published on site
• Final validation is done by EMEA

10. EVALUATION
• This report will be made by the appointed co-ordinators & circulated for review by
BWP. Then it will make appropriate recommendations
Timetable
Day -10 EMEA validation of the PMF application
Day 0 clock start(at official CPMP start date)
Day 30 CPMP inspection
Day 45 circulation of co-ordinators report to BWP & then from EMEA to
applicant
Day 75 comments BWP members
Day 83 BWP discussion/recommendation
Day 90 CPMP adoption of the evaluation report

11. • INSPECTION:- If necessary to complete the assessment of the
submitted PMF,
• CERTIFICATION :- After evaluation by CPMP, the EMEA issue PMF
certificate(5 days). In this MS & applicant will be notified
Requested by by
CPMP
REPORT SENT TO
EMEA
THEN SUBMITTED TO
CPMP