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About human cell and tissue products
Human cell and tissue products are a type of biological made from donated human cells or tissues. Examples include human cells, skin grafts, corneas, and bone grafts.
These products must be included in the Australian Register of Therapeutic Goods (ARTG) before supply. You are responsible for ensuring they meet quality, safety, and effectiveness standards.
We assess applications, monitor safety, and enforce regulations to protect public health in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and specific to biologicals. You may also have to meet obligations that apply to all biologicals and all products.
