Document ID: chunk:federal_register_of_legislation:F2020L00369:clause:1_4
Version: federal_register_of_legislation:F2020L00369
Segment Type: clause
Provision Reference: sch 1 cl 4
Character Range: 1928–4274

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) licence;
(b) manufacture;
(c) medicine;
(d)  supply; and
(e) therapeutic goods.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.
blood components means any of the following therapeutic components of blood that can be prepared by centrifugation, filtration or freezing using conventional methodologies in blood establishment:
 (a) red cells;
 (b) white cells;
 (c) platelets;
 (d) plasma;
but does not include haematopoietic progenitor cells.
haematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.
in-process material means partly processed starting material that must undergo further manufacturing before it becomes therapeutic goods in final dosage form.
packaging material, in relation to therapeutic goods, means any material used in the packaging of the therapeutic goods, excluding any outer packaging or container required solely to transport the therapeutic goods.
plasma means plasma, separated from human donor blood, intended for a number of purposes including the manufacture of further blood components, the manufacture of which is required to be licensed under Part 3-3 of the Act.
quality system means the organisational structure, responsibilities, procedures, instructions, processes and resources for implementing quality management.
secondary-packaging, in relation to therapeutic goods, means packaging that is not designed to be in direct contact with the goods.
starting material means:
 (a) in relation to therapeutic goods other than blood, blood components, haematopoietic progenitor cells or human tissue—any material used in the manufacture of the therapeutic goods, but excluding packaging material;
 (b) in relation to therapeutic goods that are blood, blood components, haematopoietic progenitor cells or human tissue—any material used in the manufacture of the therapeutic goods that may contact, or be included as an ingredient or component in, the therapeutic goods.