Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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- (-) Labelling and packaging (27)
- (-) Prescription medicines (48)
- Advanced therapies (2)
- Advertising (33)
- Advisory bodies and committees (2)
- Artificial Intelligence (AI) (3)
- Assessed listed medicines (24)
- Australian Register of Therapeutic Goods (ARTG) (30)
- Biological medicines (22)
- Blood and blood components (10)
- Breast implant hub (1)
- Clinical trials (5)
- Complementary medicines (30)
- Cosmetics (4)
- COVID-19 (9)
- Disinfectants/Sterilants (5)
- Fees and payments (3)
- Import and export (8)
- In Vitro Diagnostic medical devices (IVDs) (41)
- Legislation (8)
- Listed medicines (25)
- Manufacturing (40)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
- Medicine safety (8)
- Metal-on-metal hip replacement implants hub (1)
- Non-prescription medicines (49)
- Over the counter (OTC) medicines (36)
- Registered complementary medicines (16)
- Regulatory compliance (27)
- Safety (15)
- Scheduling (national classification system) (5)
- Shortages (3)
- Sunscreens (2)
- TGA conformity assessment certification (7)
- Therapeutic goods regulation (32)
- Unique Device Identification (UDI) hub (2)
- Vaping hub (4)
- Weight loss products (1)
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71 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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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 to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.
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GuidanceGuidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.
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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 sponsors on the fees payable and timeframes for different types of prescription medicine applications.
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GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
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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 requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance to assist sponsors to understand the process for submitting a priority registration application.
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GuidanceGuidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
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GuidanceGuidance on when and how to provide Product Information to us.
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GuidanceGuidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.
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GuidanceGuidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
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GuidanceGuidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).
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GuidanceThis guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
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GuidanceGuidance on provisional registration process for prescription medicines with provisional determination.
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GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
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GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.
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GuidanceGuidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).