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plasma for fractionation sourced from the New Zealand Blood and Organ Service, CSL Behring (Australia) Pty Ltd, CON-1395
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-1395
Duration
The consent is effective from 1 August 2025 until 1 October 2031.
Standard
Subsection 10(9), Schedule 1, Item 8(b) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
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