, Australian Red Cross Lifeblood, CON-395
Sponsor name
Australian Red Cross Lifeblood
Consent start
Consent no.
CON-395
Duration
The consent is effective from the 23rd March 2020 until the following conditions no longer remain true
Standard
Subsection 7(1) in the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
Non-compliance with standard
Inthat red cell donors for anti-D immunisation are not tested for pro-viral HIV
DNA, HAV andB19 virus.
Conditions imposed
Should new information become available in the future that indicates the risk
oftransmission of HIV, HAV or B19 virus from the red cell donor to the anti-D
plasmadonor increases, the Australian Red Cross Lifeblood must submit this
information to the TherapeuticGoodsAdministrationand obtain approval to continue
with this consent.
Import, Supply, &/or Export
Supply
Therapeutic product type
Blood, tissues, and biologicals