You are here
Consultation: Remaking of standards and legislative instruments for human cell and tissue (HCT) products, blood and blood components
This consultation closed on Sunday 11 July 2021.
The Therapeutic Goods Administration (TGA) conducted a public consultation seeking feedback on a proposal to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021.
The TGOs relevant to this consultation can be broadly categorised into three groups:
- Product-specific standards:
- Labelling requirements:
- General donor selection and testing requirements:
This consultation will also consider two other legislative instruments:
- Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011
- Therapeutic Goods (Things that are Biologicals) Specification 2019
For more information on the proposals, and to participate in the consultation, please visit the consultation hub.
The consultation opened on Thursday 27 May 2021. Interested parties responded by close of business Sunday 11 July 2021.
For enquiries relating to the consultation paper or your submission please email email@example.com.