The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Therapeutic Goods (Biologicals—Specified Things) Instrument 2021
This Instrument specifies whether certain things are or are not biologicals for the purposes of the Therapeutic Goods Act 1989.
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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 figure out 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.