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Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021
This Instrument contains the Therapeutic Goods Advertising Code. The Code specifies a range of requirements to protect the Australian public from the personal and public health risks associated with unethical, inaccurate or misleading advertising practices relating to the advertising of therapeutic goods.
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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GuidanceThis guidance aims to help advertisers understand the legislative requirements for advertising therapeutic goods on social media platforms.
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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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GuidanceGuidance on the regulatory requirements for assessed listed medicines.
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GuidanceGuidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
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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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GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
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GuidanceInformation to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.
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GuidanceGuidance on complying with therapeutic goods advertising requirements.
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GuidanceGuidance applies to self-tests and point-of-care combo test kits.
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GuidanceGuidance to explain what we need for software and apps that work with COVID-19 rapid antigen tests.
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GuidanceThis guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.
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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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GuidanceThis Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.
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GuidanceThis guidance explains part 7 of the Code, which outlines rules for using samples and incentives when advertising therapeutic goods.
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GuidanceThis guidance explains parts 2 and 3 of the Code, which requires advertising about therapeutic goods to be accurate, balanced, safe and not misleading.
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GuidanceThis Guidance explains part 9 of the Code, which has requirements about advertising the price of prescription medicines and certain pharmacist-only medicines to the public.
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GuidanceGuidance on clinical performance requirements and risk mitigation strategies.
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GuidanceThis guidance helps providers of digital mental health services or products to understand their regulatory obligations.
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GuidanceGuidance on our expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for chlamydia, gonorrhoea and syphilis.
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GuidanceGuidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.
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GuidanceHow to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.
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GuidanceGuidance for sponsors of COVID-19 IVDs about their ongoing obligations
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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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GuidanceGuidance to determine the level of regulation of PRP, PRF or conditioned serum products for therapeutic use.
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GuidanceGuidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).
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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 how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceGuidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
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GuidanceIf your business is involved with medicinal cannabis products or health services involving medicinal cannabis, this guidance will help ensure you do not unlawfully advertise medicinal cannabis to consumers. This includes through the promotion of your business or services.
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GuidanceGuidance about how to promote your business and service, without advertising biologicals to the public.
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GuidanceThis guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements in Australia.
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GuidanceGuidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
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GuidanceGuidance about how we define and regulate listed disinfectants, including how to submit a product application and the supporting data and other information required.
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GuidanceThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
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GuidanceThis guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.
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GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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GuidanceGuidance on the use of permitted indications in Listed complementary medicines.
Product types
- Biologicals
- Medical devices
- Medicines
- Unapproved therapeutic goods
- Faecal microbiota transplant products
- Human cell and tissue products
- Assessed listed medicines
- Listed medicines
- Over-the-counter medicines
- Prescription medicines
- Registered complementary medicines
- Therapeutic sunscreens
- Disinfectants and sterilants
- Tampons and menstrual cups