Certain autologous human cell and tissue products may be eligible for exemption from some regulatory requirements, but you must:
meet specific eligibility criteria
fulfil some regulatory obligations
To understand if your product is eligible and what regulatory requirements you must still comply with, refer to Exempt autologous HCTs.
We encourage supply of biologicals that are on the ARTG because they have been evaluated for quality, safety and efficacy. However, if you need to supply a biological that is not on the ARTG (an 'unapproved' biological'), the following pathways are available, depending on whether the use is:
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.