THERAPEUTIC GOODS ACT 1989
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This Order sets safety and quality rules for cord blood banking in Australia—covering blood collected from placenta and umbilical cord—and requires facilities that collect, process, test, bank or release haematopoietic progenitor cells for transplant to follow the international FACT‑NetCord standards (Third Edition, Dec 2006). It applies to cord blood banks, hospitals and labs involved in therapeutic use, ensuring internationally consistent safety for patients; it replaces TGO73 (2005).
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Direct links to the current provisions in Therapeutic Goods Order No. 75 - Standard for Haematopoietic Progenitor Cells Derived from Cord Blood (01/08/2007).
STANDARD FOR HAEMATOPOIETIC PROGENITOR CELLS DERIVED FROM CORD BLOOD
I, DAVID GRAHAM, delegate of the Minister for Health and Ageing for the purposes
of section 10 of the Therapeutic Goods Act 1989 and acting under that section, having
consulted with the Therapeutic Goods Committee in accordance with subsection 10(4)
of that Act, HEREBY:
1. REVOKE Therapeutic Goods Order No 73 “Standards for haematopoietic progenitor cells derived from cord blood” (TGO73) made on 8th June 2005; and
In this order:
Definitions
“haematopoietic progenitor cells” means primitive pluripotent haematopoietic cells
capable of self-renewal as well as maturation into any of the haematopoietic lineages,
including committed and lineage-restricted progenitor cells;
"cord blood" means blood collected from human placental and umbilical cord blood vessels;
Standards and requirements:
Haematopoietic progenitor cells derived from cord blood
This Order commences from the day after it is registered on the Federal Register of Legislative Instruments.
Dated this first day of August 2007
David Graham
Delegate of the Minister for Health and Ageing
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
STANDARD FOR HAEMATOPOIETIC PROGENITOR CELLS DERIVED FROM CORD BLOOD
I, DAVID GRAHAM, delegate of the Minister for Health and Ageing for the purposes
of section 10 of the Therapeutic Goods Act 1989 and acting under that section, having
consulted with the Therapeutic Goods Committee in accordance with subsection 10(4)
of that Act, HEREBY:
1. REVOKE Therapeutic Goods Order No 73 “Standards for haematopoietic progenitor cells derived from cord blood” (TGO73) made on 8th June 2005; and
In this order:
Definitions
“haematopoietic progenitor cells” means primitive pluripotent haematopoietic cells
capable of self-renewal as well as maturation into any of the haematopoietic lineages,
including committed and lineage-restricted progenitor cells;
"cord blood" means blood collected from human placental and umbilical cord blood vessels;
Standards and requirements:
Haematopoietic progenitor cells derived from cord blood
This Order commences from the day after it is registered on the Federal Register of Legislative Instruments.
Dated this first day of August 2007
David Graham
Delegate of the Minister for Health and Ageing