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Blood and blood components, Australian Red Cross Blood Service, CON-287
Product name
Blood and blood components
Sponsor name
Australian Red Cross Blood Service
Consent start
Consent no.
CON-287
Duration
The consent is effective from the 20 July 2018 until the following conditions no longer remain true.
Standard
The deferral period for donors with a history of coronary artery disease in the Council of Europe Guide to the preparation, use and quality assurance of blood components (14th edition) (CoE Guide), as specified in Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components
Non-compliance with standard
People who have a history of coronary artery disease can be accepted as blood
donors if they meet the new criteria outlined in the Guidelines for the
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 coronary artery disease, the 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