You must comply with regulatory requirements when manufacturing, supplying, or distributing biological products.
Biological products must be manufactured in compliance with recognised Good Manufacturing Practice (GMP) and product standards to ensure their quality, safety and efficacy. These standards govern all aspects of production, testing, and release, with additional controls for biological variability and contamination risks.
You are responsible for quality during production. You must handle supply, transport and distribution carefully to avoid contamination or damage.
We regulate these activities to protect public health and ensure biologicals remain safe and effective.
If you import or export biologicals, you need to comply with Australian laws.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about biologicals, and specific types of biologicals. You may also have to meet obligations that apply to all products.
Supply
Understand your obligations to manage the ongoing supply of products.
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PageHow to supply a therapeutic good and get started. Find out how to confirm your product is a therapeutic good, how it's regulated and if it needs to be entered in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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GuidanceRelease on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.
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GuidanceGuidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.
Import and export
Access requirements for import and export of therapeutic goods.
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PageInformation on the legal requirements for exporting medicines, medical devices and human substances from Australia.
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PageInformation on the legal requirements for importing therapeutic goods into Australia, including 'unapproved' therapeutic goods and controlled substances.
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PageSponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.