Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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309 result(s) found, displaying 26 to 50
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GuidanceHow to confirm that your OTC application is an N1 application and how to compile the information and assurances for N1 applications.
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GuidanceGuidance about how Clinical Decision Support System (CDSS) software is regulated. Find out when this software is exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).
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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 for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
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GuidanceGuidance to help sponsors determine if their therapeutic goods are medicines, biologicals, or medical devices.
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GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
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GuidanceGuidance on how medical devices must comply with the Essential Principles.
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GuidanceGuidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.
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GuidanceThis guidance aims to help advertisers understand the legislative requirements for advertising therapeutic goods on social media platforms.
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GuidanceThis guidance outlines pharmacists’ regulatory responsibilities when supplying therapeutic vapes to support patients in quitting smoking or managing nicotine dependence.
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GuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
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GuidanceGuidance providing an overview of listed medicines and assessed listed medicines pathways and legislative requirements.
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GuidanceGuidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceThis guidance is for sponsors of applications for inclusion of medical devices, including in vitro diagnostic (IVD) devices, in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceThis guidance explains good manufacturing practice (GMP) requirements for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens.
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GuidanceGuidance for manufacturers to help you manage risks and meet regulatory requirements.
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GuidanceThis guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.
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GuidanceGuidance to help sponsors comply with changes to the Permissible Ingredients Determination.
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GuidanceGuidance on how to meet regulatory requirements for the manufacture and supply of tampons in Australia.
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GuidanceGuidance for what to do if the sponsor of a therapeutic good changes.
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GuidanceGuidance on GCP inspections for clinical trial sites of investigational biologicals, medicines and medical devices regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.
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GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
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GuidanceGuidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing.
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GuidanceGuidance for manufacturers and sponsors (including health professionals) on how we define and regulate custom-made medical devices (CMMDs).
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GuidanceGuidance for manufacturers and sponsors of personalised medical devices, including health professionals. Learn what we mean by ‘specified articles’ and the difference between exempt vs excluded products.