All blood components as per the Technical Master File (TMF) in Australia, including clinical components and plasma for fractionation, notwithstanding they do not conform to the requirements of Therapeutic Goods Order 102., Australian Red Cross Lifeblood,
Product name
All blood components as per the Technical Master File (TMF) in Australia, including clinical components and plasma for fractionation, notwithstanding they do not conform to the requirements of Therapeutic Goods Order 102.
Sponsor name
Australian Red Cross Lifeblood
ARTG
Consent start
Consent no.
CON-956
Standard
Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019 Subsection 7(1) that specifies the requirements in relation to blood and blood components as those set out in the Council of Europe Guide (CoE Guide) for the preparation, use and quality assurance of blood components (19th edition).
Non-compliance with standard
The donor deferral period for Australia is reduced from 12 months to 3 months
for donors reporting the following activities ' for male donors male-to-male
sex' for female donors sex with a man who has ever had sex with a man' for
transgender donors sexual contact with a male' sex work' sexual contact with a
sex worker (male or female)Page 2 of 5' overseas sexual contact with a resident
of a HIV high prevalence country' sexual contact with an injecting drug user
(current or past)' sexual contact with a partner known to be infected with a
blood-borne virus (HIV, HBV, HCV or HTLV)
Conditions imposed
* Should new information become available in the future that indicates the risk
of transmission of infectious diseases from donors has increased, Australian
Red Cross Lifeblood must submit this information to the Therapeutics Goods
Administration and obtain approval to continue with this consent.
* Due to uncertainty regarding the impact of this change on the rate of
non-compliance to donor selection questions for Australian donors, Lifeblood
should assess the non-compliance rate of high-risk donors and monitor the
return rate for donors and provide this information to the Therapeutics
Goods Administration for review within two years of the date of this
approval.
Therapeutic product type
Blood, tissues, and biologicals