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Dear stakeholders,
Thank you for your feedback and engagement in the remaking of Therapeutic Goods Orders (TGOs), and legislative instruments which relate to human cell and tissue (HCT) products, including blood and blood components. Specifically these were TGOs 83, 84, 85, 86, 87 and 88, which describe standards relating to these goods and an instrument which specifies what are or are not biologicals.
Your feedback has informed the remaking of the TGOs, the instrument and associated guidance documents.
Please find important information about the potential impact to your operations of the remade standards and legislative instrument for human cell and tissue (HCT) products, blood and blood components that come into force on 30 September 2021.
The table below includes links to:
- remade standards (TGO 107, TGO 108 and TGO 109);
- guidance documents for TGO 107, TGO 108 and TGO 109; and
- mapping documents tracing the sections in remade TGOs (TGO 107, TGO 108 and TGO 109) back to the current TGOs (TGO 83, 84, 85, 86, 87 and 88).
| Remade TGO | Supersedes | Clause by clause map | Guidance document |
|---|---|---|---|
| TGO 107 | TGO 87 | ||
| TGO 108 | TGO 88 | ||
| TGO 83, 84, 85, 86 + parts of TGO 88 |
Clause-by-Clause tracking for TGO109 from sunsetting standards |
What do current sponsors and manufacturers have to do?
Sponsors of existing HCT products will be required to submit a single notification for included biologicals to confirm their ongoing compliance after these TGOs are remade. This will be in the form of a Notification, Code PT. Sponsors will be required to provide a document that indicates how compliance to each of the new Standards is being met. Further information regarding the application process can be found in the guidance documents Applying for inclusion of a Class 2, 3 or 4 biological on the ARTG or Varying biological entries on the ARTG.
Transition period
To assist industry the Orders provide a transition period of 12 months from 30 September 2021 to 30 September 2022. Here the former Orders may be conformed with despite their repeal as an alternative to the standards for human cell and tissue (HCT) products, blood and blood components constituted by the respective Orders.
The exception to this are donors whose ocular tissue will be released for supply solely for the purpose of corneal transplantation ('cornea only donors') as TGO 108 now mandates additional testing for these donors. An extended transition timeframe of 3 years for 'cornea only donors' from additional donor testing requirements in TGO 108 will be applied to allow adequate time to access appropriate testing facilities in some states and territories.
How can you get further specific advice?
If you would like further advice from us, the following options are available:
- Download and complete a Request for advice - Biologicals form, and send to bloodandtissues@tga.gov.au
- Request a pre-submission meeting
Please forward this information to other interested parties or providers those are likely to be affected by these changes.
We encourage you to commence action to address the upcoming changes to the new regulatory requirements sooner rather than later.