blood components including red cells, platelets, plasma for transfusion and plasma for fractionation as defined in the Lifeblood TMF, Australian Red Cross Lifeblood, CON-969
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
ARTG
Consent start
Consent no.
CON-969
Standard
The Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019; Section 7(4) and Therapeutic Goods (Standard for Human Cell and Tissue Products '“ Donor Screening Requirements) (TGO 108) Order; Part 2 Section 10 (9) Schedule 1 Item 8(b).
Non-compliance with standard
The blood components including red cells, platelets, plasma for transfusion and
plasma for fractionation, will not comply with the requirement of indefinite
geographical deferral for variant Creutzfeldt-Jakob disease (vCJD) risk,
applicable to blood and plasma donors having spent a cumulative length of time
of 6 months or more in the UK between 1980 and 1996. Blood and plasma donors
will not be deferred for potential environmental exposure to vCJD for having
spent a cumulative length of time of 6 months or more in the UK between 1980 and
1996.
Conditions imposed
That Lifeblood continues to monitor the literature and informs the Therapeutic
Goods Administration of any new evidence that substantively alters the
estimated risks, such that they become unacceptable.
Therapeutic product type
Blood, tissues, and biologicals