The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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- Advertising (32)
- Advisory bodies and committees (1)
- Assessed listed medicines (3)
- Australian Register of Therapeutic Goods (ARTG) (5)
- Biological medicines (3)
- Clinical trials (2)
- Complementary medicines (7)
- Cosmetics (2)
- COVID-19 (2)
- Fees and payments (1)
- In Vitro Diagnostic medical devices (IVDs) (3)
- Labelling and packaging (10)
- Legislation (1)
- Listed medicines (1)
- Manufacturing (5)
- Medical devices safety (3)
- Medicinal cannabis hub (1)
- Medicine safety (1)
- Non-prescription medicines (3)
- Over the counter (OTC) medicines (1)
- Prescription medicines (2)
- Registered complementary medicines (2)
- Regulatory compliance (4)
- Safety (2)
- Shortages (1)
- TGA conformity assessment certification (2)
- Therapeutic goods regulation (8)
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43 result(s) found, displaying 1 to 25
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GuidanceGuidance to help you understand requirements for disease information and advertising.
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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 for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
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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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GuidanceGuidance on our approved terminology for medicines.
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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 complying with therapeutic goods advertising requirements.
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GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
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GuidanceGuidance for sponsors or suppliers of biologicals in Australia on their ongoing responsibilities after a product is included on the Australian Register. of Therapeutic Goods (ARTG).
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GuidanceGuidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.
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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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GuidanceMandatory labelling requirements for biologicals and human cell and tissue materials.
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GuidanceInformation for manufacturers, sponsors and health professionals on the definition of a custom-made medical device and how we regulate them.
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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 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 7 of the Code, which outlines rules for using samples and incentives when advertising 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 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 about the regulation of sport supplements in Australia for importers and sellers.
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GuidanceGuidance for the requirements applicable to medical devices containing poisons.
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GuidanceThis guidance helps providers of digital mental health services or products to understand their regulatory obligations.
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GuidanceHow to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.