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Blood and blood components including haematopoietic progenitor cells and plasma-derived medical products are regulated as prescription medicines under the Therapeutic Goods (Manufacturing Principles) Determination.
- blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing
- blood components means therapeutic components of blood (red cells, white cells, platelets, plasma) that can be prepared by centrifugation, filtration and freezing, but not including haematopoietic progenitor cells
- plasma derived products (or that contain plasma derived products)
- recombinant products
- haematopoietic progenitor cells (HPC) used for haematopoietic reconstitution:
- HPC means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluripotent progenitor cells, or committed progenitor cells.
- Includes HPC derived from cord blood.