Plasma master file certificates

Following the positive evaluation of a plasma master file (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 more information on the PMF certification scheme, see Plasma master file (PMF) certification.

The following list contains all PMFs currently following the EMA certification scheme:

• CSL Behring (ref. EMA/H/PMF/000001/04)
• Grifols (ref. EMA/H/PMF/000002/04)
• Takeda (ref. EMA/H/PMF/000003/04)
• Prothya (ref. EMA/H/PMF/000007/04)
• Octapharma (ref. EMA/H/PMF/000008/05)
• Biotest (ref. EMA/H/PMF/000009/05)
• Kedrion (ref. EMA/H/PMF/000012/07)
• Omrix (ref. EMA/H/PMF/000013/07)
• BPL (ref. EMA/H/PMF/000014/08)
• LFB (ref. EMA/H/PMF/000015/09)

The following list contains the last issued certificates of PMFs that have been discontinued from the optional EMA certification scheme at the PMF holder's request:

• C.A.F. (last issued certificate ref. EMA/H/PMF/000010/06/AU/018/G)
• Cangene (last issued certificate ref. EMA/H/PMF/000011/06/AU/009/G)
• Sanquin US Plasma (last issued certificate ref. EMA/H/PMF/000017/14/AU/003/G)

The last issued PMF certificate and the collected plasma linked to it remain compliant with Community legislation throughout the European Union in all the products linked to this PMF at the time of the certification. 

Marketing authorisation holders are obliged to update their marketing authorisation dossiers to reflect up-to-date information on their plasma suppliers.