Plasma Master File (PMF)

In June 2003, European legislation (Commission Directive 2003/63/EC) established the concept of the ‘Plasma Master File’ (PMF). The 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 PMF is a separate set of documentation from the medicinal product dossier for a Marketing Authorisation.
The PMF certification is an optional procedure that follows a similar system to the Marketing Authorisation evaluation procedure at the European Medicines Agency (the ‘centralised procedure’). This procedure is called the 1st step.

Following the satisfactory outcome of an evaluation, the Agency issues a PMF Certificate of compliance with Community legislation, which is valid throughout the European Community. After the certification, it is the responsibility of the Marketing Authorisation Holder to update its medicinal product licence(s) and to incorporate the certified PMF in its Marketing Authorisation(s). This procedure is called the 2nd step.

For medicinal products that have been evaluated by the Agency through the Centralised Procedure and authorised by the European Commission, the public can find a summary of the quality and safety of the plasma in the product's European Public Assessment Report (EPAR).

The Plasma Master File (PMF) addresses the following topics, click on a link to go to the page:

• Certifications
• Submissions
• Procedural guidelines
• Dossier requirements
• General information for applicants
• Background documents
• Coordinators list