Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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39 result(s) found, displaying 1 to 25
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GuidanceGuidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
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GuidanceProvides guidance on the regulatory requirements for labels and other medicine presentation.
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GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
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GuidanceTimeframes for supplying UDI compliant medical devices in Australia
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GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
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GuidanceGuidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.
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GuidanceThis guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.
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GuidanceGuidance on the regulatory requirements for assessed listed medicines.
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GuidanceGuidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.
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GuidanceGuidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
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GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
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GuidanceGuidance on how to provide the required patient information materials with all implantable and active implantable medical devices.
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GuidanceThis guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
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GuidanceGuidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
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GuidanceGuidance for sponsors on the process for including IVD medical devices in the ARTG.
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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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GuidanceGuidance on requirements for Australian market authorisation of tablets containing aspirin, for an OTC new medicine N2 application.
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GuidanceGuidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).
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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 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 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 manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.