Remaking of Sunsetting Instruments without significant amendments – Department of Health
On 28 September, the Department of Health remade without significant amendments a number of Standards and Instruments for human cell and tissue (HCT) products, blood and blood components, which were due to sunset on 1 October 2021. The instruments comprise:
- TGO 83: Standards for human musculoskeletal tissue
- TGO 84: Standards for human cardiovascular tissue
- TGO 85: Standards for human ocular tissue
- TGO 86: Standards for human skin
- TGO 87: General requirements for the labelling of biologicals.
TGO 88: Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products was also reviewed. While this instrument does not sunset until 1 October 2023, it cross-references TGOs 83-87 and so was reviewed at the same time to provide clarity across these HCTrelevant TGOs.
The newly made instruments replacing the above TGOs will sunset on 1 October 2031 and are listed below:
- Therapeutic Goods (Standard for Biologicals-Labelling Requirements) (TGO 107) Order 2021
- Therapeutic Goods (Standard for Human Cell and Tissue Products-Donor Screening Requirements) (TGO 108) Order 2021
- Therapeutic Goods (Standards for Biologicals-General and Specific Requirements) (TGO 109) Order 2021
- Therapeutic Goods (Standards for Biologicals) Repeal Instrument 2021
- Therapeutic Goods (Consequential Amendments-TGO 108) Instrument 2021.
The newly made Therapeutic Goods (Biologicals-Specified Things) Instrument 2021 will also sunset on 1 October 2031 and replaces two older instruments to, principally, provide a single snapshot of products that the Secretary of the Department of Health has specified are, or are not, biologicals. One of these instruments was due to sunset on 1 October 2021 – the Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011.
Consistent with Government’s best practice regulation requirements for sunsetting instruments, the Department of Health has, after consultation with stakeholders, assessed the instruments as operating effectively and efficiently. Therefore, a Regulation Impact Statement is not required for remaking these instruments.