Plasma for fractionation as per the Technical Master File (TMF) in Australia, Australian Red Cross Lifeblood, CON-957
Product name
Plasma for fractionation as per the Technical Master File (TMF) in Australia
Sponsor name
Australian Red Cross Lifeblood
ARTG
Consent start
Consent no.
CON-957
Standard
Schedule 1 (10 (c)) Therapeutic Goods Order (TGO) 108, Standard for Human Cell and Tissue Products'”Donor Screening Requirements
Non-compliance with standard
The product does not conform to the requirements of TGO 108, in that persons who
have a tattoo performed at a licenced/registered tattoo parlour or cosmetic
clinic in Australia can be accepted as a donor for plasma for fractionationonly
with no deferral period from the time of the last tattoo procedure.
Conditions imposed
The consent to supply those goods that do not conform to standards is restricted
to donors who donate plasma for fractionation and does not include fresh blood
products intended for clinical use.
Therapeutic product type
Blood, tissues, and biologicals