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Blood and blood components, Australian Red Cross Blood Service, CON-319
Product name
Blood and blood components
Sponsor name
Australian Red Cross Blood Service
Consent start
Consent no.
CON-319
Duration
The consent is effective from 25 January 2019 until the specified conditions no longer remain true
Standard
The product does not comply with the deferral requirements for donors with severe cardiac arrhythmia outlined in Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components (TGO 81) - Council of Europe Guide to the preparation, use and quality assurance of blood components (18th edition) (CoE Guide)
Non-compliance with standard
People who have a history of severe cardiac arrhythmia can be accepted as blood
donors if they meet the new criteria detailed in the Updated Arrhythmias
Guidelines in the Guidelines for Selection of Blood Donors (GSBD)
Conditions imposed
Should new information becomes available in the future, indicating that the
blood donation is having a negative impact on the health and safety of patients
with a history of arrhythmias, the Australian Red Cross Blood Service (ARCBS)
must submit this information to the TGA and obtain approval to continue with
this exemption.
Import, Supply, &/or Export
Supply
Therapeutic product type
Blood, tissues, and biologicals