EMA Switches to Electronic Submission for Plasma Product Applications
| Posted: 8 June 2012
By Alexander Gaffney
The European Medicines Agency (EMA) announced this week the launch of a new electronic form for submitting plasma master file (PMF) application to the agency, replacing two existing forms.
Plasma products are protein-based medicinal products typically utilized in blood transfusions, and are regulated by EMA. Sponsors looking to obtain certification for the plasma-based product must submit the PMF, which looks to control plasma source material, data and facilities inspections.
EMA’s new PMF database is known as the PMF manager, and is available via EMA’s website in the form of a downloadable ZIP file.
EMA - European Medicines Agency launches new electronic form for submission of plasma-master-file applications