site.btaHealth Minister Halts Export of Vital Medicinal Product

Health Minister Silvi Kirilov has banned the export of NeoRecormon, used for replacement therapy in chronic kidney failure, his Ministry said. The aim is to ensure therapy for Bulgarian patients and their access to uninterrupted treatment.

The ban will be in effect for six months, until February 15, 2026. NeoRecormon is the brand name for Erythropoietin (Epoetin beta).

The medicine is an injectable solution in a prefilled syringe, administered one to three times per week to patients with chronic kidney failure, including end-stage disease, the Ministry said. This decision was prompted by an analysis of stock levels, consumption and official notifications from the marketing authorization holder about a temporary suspension of sales and delayed deliveries.

The Health Ministry will send a notification under Directive (EU) 2015/1535 and, if needed, invoke the designated emergency procedure. The goal is for every available package to remain in Bulgaria for local patients so that their therapy is not interrupted.