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Therapeutic Goods Order No. 74 - Standards for Blood Components (03/01/2006)

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THERAPEUTIC GOODS ACT 1989
   
THERAPEUTIC GOODS ORDER NO. 74
    STANDARDS FOR BLOOD COMPONENTS     I, DAVID TREVOR 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. 72 “Standards for Blood Components” (TGO72) made on 8th April 2004; and   (2)   DETERMINE that the matters specified in this Order constitute standards for blood and blood components other than for blood and blood components that are:   (a)    collected by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, in the course of medical treatment and for the purposes of diagnosis of, and testing for, a medical condition; or   (b)   manufactured by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, for therapeutic application to a patient under the practitioner’s care; or   (c)    manufactured by a blood donation centre for a medical practitioner who is registered under a law of a State or Territory, for therapeutic application to a particular patient under the practitioner’s care.   In this order:   Definitions   “blood” means whole blood extracted from human donors;   “blood components” means therapeutic components that have been manufactured from blood including red cells, white cells, platelets and plasma for transfusion, but not including haematopoietic progenitor cells.   “blood products” means any product derived from human blood or plasma.   “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.   Standards and requirements:   1.      Blood and blood components must meet the requirements of the Council of Europe document titled “Guide to the preparation, use and quality assurance of blood components” 11th edition, dated January 2005, Council of Europe Publishing with the following exception:     the reference to tropical areas under the heading ‘Tropical Diseases” on page 39 of the Council of Europe document titled “Guide to the preparation, use and quality assurance of blood components” 11th edition, dated January 2005, Council of Europe Publishing should not be taken to include areas within Australia.   2.      Blood and blood components must only be manufactured from blood that tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology.   3.      Blood and blood components must not be manufactured from donors who have lived in or visited England, Scotland, Wales, Northern Ireland or the Isle of Man for a cumulative period of six months or more, between 1st January 1980 and 31st December 1996 inclusive.   4.      Blood and blood components must not be manufactured from donors who have received a transfusion or injection of blood or blood products while in England, Scotland, Wales, Northern Island or the Isle of Man from 1st January 1980 onwards.     This Order commences from the day after the day it is registered on the Federal Register of Legislative Instruments.      Dated this third day of  January 2006                 David Graham Delegate of the Minister for Health and Ageing