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plasma for fractionation sourced from the Hong Kong Red Cross Blood Transfusion Service, CSL Behring (Australia) Pty Ltd, CON-1363
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-1363
Duration
The consent is effective from 13 June 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 product does not comply with requirements that 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
Import, Supply, &/or Export
import
Therapeutic product type
Blood, tissues, and biologicals