Resources and guidance

Access regulatory guidance for industry, alongside tailored information for consumers and health professionals.

On this page:

For consumers

Learn how to safely access and use different health products in Australia.

Travelling with medicines and medical devices

If you're travelling to or from Australia, bring your medicines or medical devices with you.
Vapes: information for individuals and patients

Find out about therapeutic vapes for smoking cessation and the management of nicotine dependence, how they are regulated, and how they can be accessed.
Medicine shortages information for consumers

Understand medicine shortages and what to do if your medicine is affected.

Understand your obligations and access resources to support your work.

Guidance

Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
Australian Regulatory Guidelines (ARGs)

The ARGs group together resources about regulatory requirements for biologicals, medical devices and medicines.
What's new

Find all our recently published information in one place.

Access product information and safety updates to support your practice.

Vapes: information for prescribers

Learn about the regulatory framework for prescribing therapeutic vapes for smoking cessation or the management of nicotine dependence.
Safety updates

Refer to our articles for health professionals about health products and emerging safety issues.
Medicine shortages information for health professionals

General medicine shortage information and what to do if your patient’s medicine is in shortage.

Safety alerts

Refer to the latest safety alerts for medicines or medical devices with possible risks.
Medicine shortage alerts

Find alerts about a medicine shortage.
Market actions

Find significant or consumer level recalls, product alerts and product corrections

Report a medicine or vaccine defect

Use this form to report defects that you think have arisen during manufacture, storage or handling of a medicine or vaccine.
Reporting adverse events for consumers

How to report a side effect, reaction or other problem with a therapeutic good. Your report can help keep others safe.
Reporting medical device incidents for sponsors and manufacturers

Industry portal - Log in to report medical device incidents via the Medical Device Incident Reporting (MDIR) system.
Report a perceived breach or questionable practices

Use this form to report a perceived breach of the Therapeutic Goods Act, counterfeit products or questionable practices in relation to therapeutic products.
Report non-compliant advertising

Use this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.

Legislation

Find listed information for the legislation that is referred to in our Guidance content.
Guidance

Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
Resources

Search our resources for checklists, user guides, international scientific guidelines, compositional guidelines and forms.
Explore by topic

Topics of interest for consumers and health professions.
Datasets

Search the Australian Register of Therapeutic Goods (ARTG), and safety alerts, product shortages, approvals, and regulatory actions.
Decision trees

Use decision trees to check rules for therapeutic goods in Australia, including classification, reporting obligations, advertising requirements and supply pathways.
Transactions

See a list of transactions which provide overview information about applications and submissions.