Document ID: chunk:federal_register_of_legislation:F2019L00389:clause:2_4
Version: federal_register_of_legislation:F2019L00389
Segment Type: clause
Provision Reference: sch 2 cl 4
Character Range: 1793–3158

4  Definitions
Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:
(a) manufacture; and
(b) 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.
Guide means the Guide to the preparation, use and quality assurance of blood components, 19th edition, 2017, published by the Council of Europe, as in force or existing immediately before the commencement of this instrument.
Note: The Guide is published by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe at: www.edqm.eu.
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.
HBV means hepatitis B virus.
HCV means hepatitis C virus.
HIV-1 means human immunodeficiency virus.