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Blood products., Australian Red Cross Blood Service, CON-280
Product name
Blood products.
Sponsor name
Australian Red Cross Blood Service
Consent start
Consent no.
CON-280
Duration
The consent is effective from 20 July 2018 until the following conditions no longer remain true.
Standard
The product does not conform to the deferral requirements of Therapeutic Goods Order No. 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
The 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