Blood and blood components, Australian Red Cross Blood Service, CON-273
Product name
Blood and blood components
Sponsor name
Australian Red Cross Blood Service
Consent start
Consent no.
CON-273
Duration
The consent is effective from 6 June 2018 until the conditions no longer remain true.
Standard
Therapeutic Goods Order 81 - Standards for Blood and Blood Components - Council of Europe Guide to the preparation, use and quality assurance of blood components (14th edition) (CoE Guide)
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 becomes available in the future, indicating changes
in the safety profile of blood donations received from patients with
haemochromatosis, the Sponsor must submit this data to the TGA for assessment
and approval.
Import, Supply, &/or Export
Supply
Therapeutic product type
Blood, tissues, and biologicals