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, Australian Red Cross Lifeblood, CON-385

Sponsor name
Australian Red Cross Lifeblood
Consent start
Consent no.
CON-385
Duration
The consent is effective from 23 March 2020 until the 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
Blood donations from therapeutic donors aged 16 and 17 years can be accepted and used for manufacturing blood components.
Conditions imposed
Should new information become available in the future, indicating changes in the safety profile of blood donations received from patients with haemochomatosis, Australian Red Cross Lifeblood must submit these data to the TGA for assessment and approval.
Import, Supply, &/or Export
Supply
Therapeutic product type
Blood, tissues, and biologicals