Plasma-derived products with marketing authorisation

A revised regulation on the supply of medicinal products came into force in the beginning of 2012. According to the regulation, plasma-derived products and blood components must be traceable from the blood donor to the person receiving the medicine. The traceability obligation applies to the medicinal products whose active substance is a plasma-derived component. Medicinal products where a plasma-derived component (such as albumin) is an excipient, are not subjected to batch recording. Since diagnostic radiopharmaceuticals are classified as medicinal products, they are subject to the traceability requirements too, if they contain a plasma-derived component as an active substance. Traceability requires that pharmacies must enter in a prescription diary the batch numbers of these medicinal products.. The batch recording obligation also applies to the plasma-derived medicinal products that are delivered from the hospital pharmacies and dispensaries to the nursing units.

Fimea publishes the list of plasma-derived products on it’s website and it is updated when necessary.

Further Information

  • Saarela Sirkku
    Senior Reseacher tel. +358295223429