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plasma for fractionation sourced from the Hong Kong Red Cross Blood Transfusion Service, CSL Behring (Australia) Pty Ltd, CON-1365
Product name
plasma for fractionation sourced from the Hong Kong Red Cross Blood Transfusion Service
Sponsor name
CSL Behring (Australia) Pty Ltd
Consent start
Consent no.
CON-1365
Duration
The consent is effective from 13 June 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 does not comply as Hong Kong 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
You 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