Blood and blood components, Australian Red Cross Blood Service, CON-286
Product name
Blood and blood components
Sponsor name
Australian Red Cross Blood Service
ARTG
Consent start
Consent no.
CON-286
Standard
Medical review requirements for donors aged 60 years and over - Council of Europe Guide to the preparation, use and quality assurance of blood components 14th Edition, as specified in Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components
Non-compliance with standard
First time donors over the age of 60 years and less than 81 years (exclusive)
can be accepted without medical review. Repeat and regular donors aged 65 years
and older may be accepted without the need for a medical review. There is no
upper age limit for repeat and regular donors.
Conditions imposed
Products in relation to which this consent is given must comply with all
other applicable requirements of the Council of Europe Guide to the preparation,
use and quality assurance of blood components 14th Edition that are applicable
under Therapeutic Goods Order No. 81 and other applicable standards.
Therapeutic product type
Blood, tissues, and biologicals