All blood components as per the Lifeblood Technical Master File, Australian Red Cross Lifeblood, CON-912
Product name
All blood components as per the Lifeblood Technical Master File
Sponsor name
Australian Red Cross Lifeblood
ARTG
Consent start
Consent no.
CON-912
Standard
Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 / Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components 19th edition
Non-compliance with standard
Blood components as per the Lifeblood Technical Master File do not conform to
the donor haemoglobin requirements of Therapeutic Goods (Standard for Blood and
Blood Components) (TGO 102) Order 2019 / Council of Europe Guide to the
Preparation, Use and Quality Assurance of Blood Components 19th edition, in that
the current Hb limits are below CoE standards for whole blood and apheresis
donors.
Conditions imposed
A condition of the exemption is that during the exemption Lifeblood will submit
to Therapeutic Goods Administration a detailed proposal for the management of
donor Hb and ferritin levels and provide data from preliminary studies as it
becomes available.
Therapeutic product type
Blood, tissues, and biologicals