To supply disinfectants and sterilants in Australia, you must meet regulatory requirements. These include safety, quality and performance standards.
Products that are exempt, from Australian Register of Therapeutic Goods inclusion, still need to meet standards to be safe, effective and consistent.
If you import or export, you must comply with all legal requirements. This includes correctly classifying your product and documentation requirements.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to other therapeutic goods (OTG). You may also have to meet obligations that apply to all OTG and all products.
Supply
Understand your obligations to manage the ongoing supply of products.
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GuidanceGuidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
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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).
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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GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.