plasma for fractionation sourced from the Taiwan Blood Services Foundation, CSL Behring (Australia) Pty Ltd, CON-1423
Product name
plasma for fractionation sourced from the Taiwan Blood Services Foundation
Sponsor name
CSL Behring (Australia) Pty Ltd
Consent start
Consent no.
CON-1423
Duration
The consent is effective from 23 October 2025 until 1 April 2029.
Standard
Paragraphs 7(4)(a) and (b) of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
Non-compliance with standard
The products do not comply because 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
The sponsors are required to inform the TGA of any new evidence that
substantively alters the estimated risks in the submitted information, such that
they may become unacceptable.
Import, Supply, &/or Export
import
Therapeutic product type
Blood, tissues, and biologicals