Guidance

Guidance to help you understand requirements for disease information and advertising.

Guidance on the regulatory requirements for assessed listed medicines.

Guidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.

Guidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.

This guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.

Guidance on complying with therapeutic goods advertising requirements.

Guidance about how to advertise therapeutic goods exclusively to health professionals.

This guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.

This 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.

Information for manufacturers, sponsors and health professionals on the definition of a custom-made medical device and how we regulate them.

This guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.

This guidance explains parts 2 and 3 of the Code, which requires advertising about therapeutic goods to be accurate, balanced, safe and not misleading.

This guidance explains part 7 of the Code, which outlines rules for using samples and incentives when advertising therapeutic goods.

This Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.

This 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.

Guidance about the regulation of sport supplements in Australia for importers and sellers.

Guidance for the requirements applicable to medical devices containing poisons.

This guidance helps providers of digital mental health services or products to understand their regulatory obligations.

How to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.

Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of 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 relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.

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

Guidance on advertising services that involve therapeutic goods.