Plasma Master File dossier format and submission requirements

HumanRegulatory and procedural guidanceResearch and development

On Monday, 12 January 2026, between 07:00 and 10:00 CET (Amsterdam time), this website will be unavailable due to scheduled maintenance.

All applications should be submitted electronically in electronic common technical document (eCTD) format to the European Medicines Agency and via eSubmission.