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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 on the regulatory requirements for assessed listed medicines.
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GuidanceGuidance providing an overview of listed medicines and listed assessed medicines pathways and legislative requirements.
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GuidanceGuidance on when and how to provide Product Information to us.
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GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
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GuidanceThis guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.
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GuidanceThis guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
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GuidanceGuidance for the requirements applicable to medical devices containing poisons.
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GuidanceGuidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.
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GuidanceThis guidance provides for a nationally uniform approach to retail storage of Schedule 6 and Schedule 7 poisons.
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GuidanceGuidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.
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GuidanceGuidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.
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GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybin from 1 July 2023.
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GuidanceGuidance on advertising services that involve therapeutic goods.
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GuidanceGuidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.
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GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
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GuidanceInformation required to establish quality for listed medicines