Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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61 result(s) found, displaying 26 to 50
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GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.
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GuidanceGuidance about the process of applying for a priority determination, which is the first step of the priority review registration pathway.
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GuidanceGuidance for the deletion of commercially confidential and personal information in an Australian Public Assessment Report (AusPAR).
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GuidanceGuidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.
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GuidanceGuidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.
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GuidanceGuidance about the regulation of sport supplements in Australia for importers and sellers.
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GuidanceGuidance on how to request early scientific advice on a biowaiver justification.
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GuidanceGuidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.
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GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
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GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
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GuidanceGuidance on the quality and labelling requirements of Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024.
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GuidanceGuidance to help you understand which therapeutic goods will be regulated as a biological.
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GuidanceGuidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.
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GuidanceGuidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.
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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 for the requirements applicable to medical devices containing poisons.
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GuidanceHow to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.
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GuidanceGuidance on mandatory warning statements for labels of medicines containing neuromuscular blocking agents.
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GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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GuidanceGuidance for sponsors on how and when to use a boxed warning in PI or a CMI.
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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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GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.
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GuidanceGuidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses.
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GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.