Supply and distribution for biologicals

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.