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All blood components as per the Lifeblood Technical Master File, Australian Red Cross Lifeblood, CON-1289
Product name
All blood components as per the Lifeblood Technical Master File
Sponsor name
Australian Red Cross Lifeblood
Consent start
Consent no.
CON-1289
Duration
The consent is effective from 29 October 2024 until 9 November 2025.
Standard
Chapter 2 Principles of donor selection, Apheresis donors (Page 146)
Chapter 2 Standards for selection of donors, Whole blood donors (page 259) of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
Chapter 2 Standards for selection of donors, Whole blood donors (page 259) of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
Non-compliance with standard
Lifeblood donor haemoglobin acceptable ranges, previously agreed after
consultation with the TGA and in place since 2004, are: Apheresis - Female:
115-165g/L, Male: 125-185 g/L Whole blood - Female: 120-165g/L, Male: 130-185
g/L The products may not comply with the requirement of TGO 102 as blood and
apheresis donors are currently accepted with haemoglobin levels below the above
levels described in the standard.
Conditions imposed
During the exemption, the sponsor will submit updates every 6 months to the TGA
outlining progress on implementation of a strategy for measuring donor ferritin
levels.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals