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Supply and distribution for human cell and tissue products

Understand how to legally supply, distribute, import, and export products 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.

Supply

Understand your obligations to manage the ongoing supply of products.

Import and export

Access requirements for import and export of therapeutic goods.

  • Export

    Page
    Information on the legal requirements for exporting medicines, medical devices and human substances from Australia.

  • Exporting human substances

    Guidance
    Guidance about how to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.

  • Import

    Page
    Information on the legal requirements for importing therapeutic goods into Australia, including 'unapproved' therapeutic goods and controlled substances.

  • Overseas manufacturers

    Page
    Sponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.
Product types