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all blood components as per the Lifeblood Technical Master File, Australian Red Cross Lifeblood, CON-1410
Product name
all blood components as per the Lifeblood Technical Master File
Sponsor name
Australian Red Cross Lifeblood
Consent start
Consent no.
CON-1410
Duration
The consent is effective from 18 September 2025 until 9 November 2026.
Standard
Paragraph 7(1)(a) of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
Non-compliance with standard
The products do not conform because they can be collected from donors with
haemoglobin levels in the following ranges: • Apheresis donors – Female: 115 -
165 g/L, Male: 125 - 185 g/L; • Whole blood donors – Female: 120 - 165 g/L,
Male: 130 - 185 g/L.
Conditions imposed
During the exemption period, the sponsor will submit to the TGA a comprehensive
report outlining their progress on implementing a strategy for measuring donor
ferritin levels.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals