Guidance

Guidance for industry on how to apply for consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.

Guidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.

This guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.

Guidance on the requirements that specifically apply to active medical devices.

Guidance 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).

Guidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).

Guidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.

Guidance for new sponsors on how to supply, import, and export disinfectant products.

Guidance on reporting adverse events for sponsors of medical devices.

This guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements in Australia.

Guidance for importation, supply and wholesale requirements for medicinal cannabis.

Guidance about how to promote your business and service, without advertising biologicals to the public.

Guidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses.

Guidance clarifying the interaction between our requirements and AHPRA advertising guidelines.

Guidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.

Guidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.

Guidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance on equivalence of herbal extracts in complementary medicines.

Guidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG.

If 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.

Guidance on advertising services that involve therapeutic goods.

Guidance for sponsors of certain medical devices who are required to submit annual reports.

Guidance on when software is classified as an in vitro medical device and how it is regulated.

From 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.