, Australian Red Cross Lifeblood, CON-394
Sponsor name
Australian Red Cross Lifeblood
ARTG
Consent start
Consent no.
CON-394
Standard
Subsection 7(1) in the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
Non-compliance with standard
Inthat plasma when obtained by plasmapheresis, and intended solely for the
recovery of proteins that are not labile in plasma is separated from cellular
components and frozen in a chamber at -20°C or below within 72 hours of
collection.
Conditions imposed
This consent is limited to collection centres where there are limited product
transport options for transporting plasma to a processing centre within the
required timeframe arising from the current COVID19 pandemic. This consent is
effective until the implicated transport options are resolved. Lifeblood must
advise TherapeuticGoods Administrationwhen the transport options for the
affected collection centres have been resolved.
Therapeutic product type
Blood, tissues, and biologicals