We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
plasma for fractionation sourced from the New Zealand Blood and Organ Service, CSL Behring (Australia) Pty Ltd, CON-1396
Product name
plasma for fractionation sourced from the New Zealand Blood and Organ Service
Sponsor name
CSL Behring (Australia) Pty Ltd
Consent start
Consent no.
CON-1396
Duration
The consent is effective from 1 August 2025 until 1 April 2029.
Standard
paragraph 7(4)(a) of Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
Non-compliance with standard
The products do not comply because New Zealand 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 are now eligible to donate plasma for fractionation.
Conditions imposed
The sponsor is required to inform the TGA of any new evidence that substantively
alters the estimated risks.
Import, Supply, &/or Export
import
Therapeutic product type
Blood, tissues, and biologicals