Fractionation sourced from the Taiwan Blood Services Foundation, CSL Behring (Australia) Pty Ltd , CON-1473
Product name
Fractionation sourced from the Taiwan Blood Services Foundation
Sponsor name
CSL Behring (Australia) Pty Ltd
Consent start
Consent no.
CON-1473
Duration
The consent is effective from 23 October 2025 until 1 October 2031.
Standard
Subsection 1 Items 8(b) and (c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
Taiwan plasma donors who have, lived in or visited England, Scotland, Wales,
Northern Ireland or the Isle of Man for a cumulative period of 6 months or more,
at any time between 1 January 1980 and 31 December 1996; or received a
transfusion of blood or blood components while in England, Scotland, Wales,
Northern Ireland or the Isle of Man at any time on or after 1 January 1980 are
now eligible to donate plasma for fractionation.
Conditions imposed
Import, Supply, &/or Export
import
Therapeutic product type
Blood, tissues, and biologicals