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You must comply with regulatory requirements when manufacturing 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.
We regulate these activities to protect public health and ensure biologicals remain safe and effective.
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.