Therapeutic goods compliance with the TGA
Medicines, medical devices, biologicals and other therapeutic goods supplied in Australia must be entered in the Australian Register of Therapeutic Goods (ARTG) unless exempt. Sponsors and manufacturers have ongoing obligations under the Therapeutic Goods Act 1989 (Cth). This guide covers the 10 core TGA compliance obligations.
Coverage
Australian sponsors, manufacturers, importers, wholesalers and retailers of therapeutic goods, including online pharmacies, cosmeceutical companies with therapeutic claims and medical device distributors.
Legal basis
Therapeutic Goods Act 1989 (Cth) and Therapeutic Goods Regulations 1990. Therapeutic Goods (Medical Devices) Regulations 2002. Therapeutic Goods Advertising Code 2021. Uniform Recall Procedure for Therapeutic Goods (URPTG).
The obligations
Include goods in the ARTG
Include the therapeutic goods in the ARTG under the correct pathway (listed, assessed listed, registered or included) before supply in Australia, unless an exemption applies.
Meet manufacturing and GMP requirements
Manufacture goods in facilities that hold a TGA manufacturing licence (or acceptable overseas certification) and comply with Good Manufacturing Practice.
Comply with the Essential Principles for devices
Medical devices must meet the Essential Principles for safety and performance, with appropriate conformity assessment evidence for their class.
Follow the Therapeutic Goods Advertising Code
Advertising to consumers must comply with the Advertising Code, avoid prohibited representations and not promote Schedule 4 or 8 medicines.
Report adverse events
Sponsors must report serious adverse events and problems within the mandated timeframes, including via the Database of Adverse Event Notifications.
Comply with labelling and packaging rules
Label and package goods in accordance with TGO 91, TGO 92 and device labelling requirements, including active ingredients, warnings and storage conditions.
Honour post-market surveillance obligations
Implement post-market surveillance plans, periodic reviews and unique device identifier expectations where the device class or TGA conditions require it.
Manage recalls under URPTG
Notify the TGA and coordinate recalls, hazard alerts and safety advisory notices under the Uniform Recall Procedure for Therapeutic Goods.
Keep records and respond to TGA inspections
Keep batch, distribution, complaint and advertising records, and allow TGA inspections and information-gathering notices under the Act.
Use the TGA Business Services portal
Use the TBS portal for ARTG entries, annual charges, variations and cancellations, and pay annual and low-value turnover charges when required.
What happens if you do not comply
The Therapeutic Goods Act 1989 (Cth) provides for civil penalties up to approximately $1.565 million per contravention for individuals and $15.65 million for corporations, plus criminal offences for unlawful supply, advertising and non-compliance with recalls.
Reporting requirements
Sponsors and manufacturers must submit adverse event reports, annual entry maintenance, variation notifications, recall notifications, and periodic safety updates required by TGA conditions.
What firms should do today
- Maintain a product-by-product ARTG and conformity assessment dossier
- Run a quarterly advertising compliance check aligned with the Advertising Code
- Keep adverse event reporting SLAs aligned with statutory timeframes
- Rehearse URPTG recalls with distributors at least annually
- Monitor TGA safety signals and guidance updates monthly
Compliance with Quillio
Quillio reviews supply, distribution and advertising agreements to align sponsor obligations, indemnities and recall triggers with the Therapeutic Goods Act and Advertising Code. See /resources/security.
This guide is general information about therapeutic goods compliance in Australia — not legal or regulatory advice. Sponsors should work with a specialist regulatory lawyer and TGA consultant.
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