Skin Tissue, Metro South Hospital and Health Service T/A Queensland Tissue Bank, CON-1521
Product name
Skin Tissue
Sponsor name
Metro South Hospital and Health Service T/A Queensland Tissue Bank
ARTG details
AUST I 230058
Consent start
Consent no.
CON-1521
Duration
The consent is effective from 29 April 2026 until 1 October 2031.
Standard
Schedule 1 Item 10 of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
Tissue donors who have received a tattoo as part of a medical procedure will not
be deferred for potential blood borne infection risk when the medical procedure
was performed under the following conditions: (1) With sterile items/instruments
(2) Under the guidance of a medical practitioner (3) For a specific medical
purpose (e.g., radiation therapy, colonoscopy/polyp removal) (4) At a hospital
or medical clinic performed under controlled conditions
Conditions imposed
That the sponsor continues to monitor the literature and informs the TGA of any
new evidence that substantively alters the estimated risks, such that they
become unacceptable.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals