Supply and distribution for human cell and tissue products

You must comply with regulatory requirements when supplying or distributing human cell and tissue products. 

You are responsible for maintaining quality during production, supply, transport, and distribution. 

We regulate these activities to protect public health and ensure human cell and tissue products remain safe and effective. 

If you import or export human cell and tissue products, you must comply with Australian laws. 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to biologicals. You may also have to meet obligations that apply to all biologicals and all products.