Official version of legislation
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.
Guidance referring to this legislation
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GuidanceGuidance to help sponsors determine if their therapeutic goods are medicines, biologicals, or medical devices.
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GuidanceGuidance to help you understand which therapeutic goods will be regulated as a biological.
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GuidanceAustralian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
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