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Plasma Master File Certificates | EMA Regulatory Update

The plasma master file (PMF) is a compilation of all the required scientific data on the quality and hsafety 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 Commission Directive 2003/63/EC in June 2003.

The PMF is a separate set of documentation from the dossier for a medicine's marketing authorisation.


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.

Plasma Master File (PMF) Procedural Guidelines will found below link:

Plasma Master File (PMF) procedural guidelines

Published information

A summary of the quality and safety of the plasma is available in the European public assessment report (EPAR) for medicines that have been evaluated by the Agency and authorised by the European Commission.


Following the positive evaluation of a plasma masterfile (PMF) under the PMF certification scheme, the European Medicines Agency (EMA) issues a certificate of compliance with European legislation which is valid throughout the European Union.  EMA publishes the list of all the issued PMF certificates.

For additional informations related to PMF Certifications, Submission dates, Procedure, Dossier format, Application form, Fees, Background documents visit the below link:

Plasma master file (PMF) certification

Resource person: Barbara Pirola
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