plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
2. Contents
1. Introduction
2. General Principle
3. PMF Submission
4. Pre Submission Activities
5. Structure of ectd Dossier for the PMF
6. Procedure
7. Time table for initial certification of PMF
8. Doccuments required for the PMF 2nd step
9. Envelope Elements and Metadata for the PMF Certification
Notes On PMF Dossier Particular Envelope Elments
3. INTRODUCTION
The plasma master file (PMF) 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. These data cover all aspects of the use of plasma, from collection to plasma
pool.
The concept of the PMF was established by European legislation in June 2003.
The PMF is a separate set of documentation from the dossier for a medicine's marketing authorisation.
4. General Principle
The PMF is stand-alone documentation, which is separate from the dossier for marketing
authorisation, which provides all detailed information on the characteristics of the entire
human plasma
The PMF information should therefore not be additionally included/integrated into
section 3.2.s.2.3 of the product-specific eCTD dossiers.
The PMF will be updated at least annually with the submission of the Annual update.
5. Plasma Master File (PMF) submissions
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, C PMP
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, CPMP 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.
6. Conti….
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/CPMP dates are generally fixed; other dates may be
subject to adjustments until the CPMP Scientific committee proceeds to their
adoption for every individual application.
7. Pre submission activities
Prior the submission of application the applicant should inform the relevant competent authorities
1. Letter of intent to EMEA
2. Appointment of coordinators
3. Submission and Validation
4. Evaluation
8. Structure of the eCTD Dossier for the PMF
The complete PMF scientific data package is made up of multiple files. The PMF data
should be placed in module 3 under 3-2-s-2-3 control-of-materials within the eCTD
structure.
Documentation should be included as per the CPMP guideline on the scientific
requirements for the PMF
9. Module 1 EU
1.0 Cover Letter
1.2 Application Form
1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet
1.3.2 Mockup
1.3.3 Specimen
1.3.4 Consultation with Target Patient Groups
1.3.5 Product Information already approved in the Member States
10.
11. Procedure
The first step of the PMF certification procedure is similar to the marketing-
authorisation evaluation procedure. Following the satisfactory outcome of an
evaluation, the Agency issues a PMF certificate of compliance with European
legislation. This certificate is valid throughout the European Union.
In the second step, after certification, it is the responsibility of the marketing-
authorisation holder to update its medicinal product licences and to incorporate the
certified PMF in its marketing authorisations.
15. Documents required for the PMF 2nd Step
Submission within the Product eCTD Structure
For a 2nd step PMF submission within a Marketing Authorisation, only,
the following documents should be provided for the corresponding
eCTD:
Module 1 EU
1.0 Cover letter
1.2 Application form
1.2 Certificate of Compliance
Module 2
2.3 Expert Statement regarding the impact (if any) of the PMF on the
concerned medicinal product(s)16
16. Envelope Elements and Metadata for the
PMF Certification/Recertification Dossiers
This section describes how the envelope elements and leaf metadata should be used in the eCTD when
submitting PMF dossiers.
17. Notes on PMF dossier Particular Envelope Elements:
18. 2.<Submission Description>
In all cases, the free-text envelope element <submission description> should be
used to describe
the scope related to the PMF and to further identify the submission as relating to
a Plasma
Master File, or a PMF 2nd Step. The contents of the <submission description>
envelope element
should be concise but clearly indicative of the exact content of the submission.
The submission description should not exceed 200 characters.
19. 3. <Application Number>
This is key envelope element which identifies and allows sorting of the PMF certification
submissions/application procedures. The <Application Number> envelope should always be
filled in/populated to indicate that the submission relates to the PMF.
The <Application Number> should follow this convention:
<EMEA>/<H>/<PMF holder ref. number>/<initial submission year18>/<type of change for
variations or transfers>/<procedure number (if applicable)>, all separated by slashes e.g.:
EMEA/H/PMF/000123/08
EMEA/H/PMF/000123/08/I/01
20. 4. <Invented Name>
This envelope element is not applicable for the PMF dossier.
Where an envelope element is not applicable, please indicate ‘Not Applicable’ rather than
leaving the element blank (particularly as this element is mandatory so cannot be left blank).
6. <INN>
This envelope element is not applicable for the PMF dossier.
Where an envelope element is not applicable, please indicate ‘Not Applicable’ rather than leaving the
element blank
21.
22. Updates to the PMF Dossier Sections
When there is any change to the PMF data, in line with general eCTD principles, only changed sections
should be submitted, not the entire PMF.
If the PMF-Holder wishes to covert to eCTD at the time of a variation, it is recommended that before the
actual variation is submitted, a full baseline eCTD sequence 0000 is first submitted.
Any updated sections for review associated with the variation should be subsequently sent as a following
sequence 0001
