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blood components including red cells, platelets, plasma for transfusion and plasma for fractionation as defined in the Lifeblood TMF, Australian Red Cross Lifeblood, CON-1090
Product name
blood components including red cells, platelets, plasma for transfusion and plasma for fractionation as defined in the Lifeblood TMF
Sponsor name
Australian Red Cross Lifeblood
Consent start
Consent no.
CON-1090
Duration
The consent is effective from 16 March 2023 until 1 October 2031
Standard
Part 2 Section 10 (9) Schedule 1 Item 8(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The products will not comply with the requirement of indefinite deferral for
variant Creutzfeldt-Jakob disease (vCJD) risk, applicable to blood and plasma
donors having received a transfusion or injection of blood or blood components
while in England, Scotland, Wales, Northern Ireland or the Isle of Man at any
time on or after the 1 January 1980.
Conditions imposed
1. Lifeblood continues to monitor the literature and informs the TGA of any new
evidence that substantively alters the estimated risks, such that they become
unacceptable.
2. Lifeblood does not implement the change for plasma for fractionation until
CSL Behring have submitted a variation to TGA for the change and subsequently
received approval from TGA for the change.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals