drug product intermediates manufactured from plasma sourced from the New Zealand Blood and Organ Service, CSL Behring (Australia) Pty Ltd, CON-1397
Product name
drug product intermediates manufactured from plasma sourced from the New Zealand Blood and Organ Service
Sponsor name
CSL Behring (Australia) Pty Ltd
Consent start
Consent no.
CON-1397
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 product can now be manufactured from plasma sourced from 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.
Conditions imposed
The sponsor is required to inform the TGA of any new evidence that substantively
alters the estimated risks.
Import, Supply, &/or Export
export
Therapeutic product type
Blood, tissues, and biologicals