Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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Topic
- Advanced therapies (1)
- Advertising (26)
- Assessed listed medicines (7)
- Australian Register of Therapeutic Goods (ARTG) (10)
- Biological medicines (9)
- Blood and blood components (6)
- Clinical trials (3)
- Complementary medicines (10)
- Cosmetics (2)
- COVID-19 (7)
- Disinfectants/Sterilants (3)
- Fees and payments (1)
- Import and export (5)
- In Vitro Diagnostic medical devices (IVDs) (19)
- Labelling and packaging (17)
- Legislation (6)
- Listed medicines (12)
- Manufacturing (20)
- Medical devices safety (14)
- Medicinal cannabis hub (2)
- Medicines safety (6)
- Non-prescription medicines (10)
- Over the counter (OTC) medicines (8)
- Prescription medicines (14)
- Registered complementary medicines (3)
- Regulatory compliance (15)
- Safety (9)
- Scheduling (national classification system) (3)
- Shortages (1)
- TGA conformity assessment certification (5)
- Therapeutic goods regulation (19)
- Vaping hub (3)
- Weight loss products (1)
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112 result(s) found, displaying 1 to 25
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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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GuidanceThis guidance is to assist health practitioners understand their requirements when prescribing ‘unapproved’ therapeutic goods for an individual patient using the Special Access Scheme (SAS).
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GuidanceThis guidance helps sponsors and manufacturers of ‘unapproved’ therapeutic vapes understand quality and safety requirements, under the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices) Amendment Order 2024.
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GuidanceGuidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.
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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 for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.
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GuidanceGuidance on the evidence requirements and application categories to list products with low-risk ingredients in the Australia Register of Therapeutic Goods (ARTG), with a focus on the L(A)3 application category.
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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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GuidanceGuidance on software based medical devices, that incorporate software or are software.
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GuidanceGuidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.
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GuidanceGuidance on how medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.
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GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybin from 1 July 2023.
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GuidanceGuidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
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GuidanceHow to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.
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GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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GuidanceThis guidance outlines ARTG and conformity assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know.
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GuidanceGuidance on understanding the rules for advertising therapeutic goods to consumers
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GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
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GuidanceGuidance on how to meet regulatory requirements for the manufacture and supply of tampons in Australia.
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GuidanceThis guidance will help ensure you do not unlawfully advertise medicinal cannabis to consumers, if you give out information about medicinal cannabis or advertise health services.
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GuidanceGuidance on advertising services that involve therapeutic goods.