The table below sets out our priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 1 July 2024 to 30 June 2025.
We have extended our Import, Advertising and Supply Compliance Priorities from the 2023-24 period into 2024-25.
Our continued focus on these areas aims to improve public safety, address serious breaches of the legislation and address high levels of non-compliance in these industry sectors.
They should be read along with our Regulatory Compliance Framework and How we manage advertising compliance which describe our approach to compliance, including how we encourage compliance and respond to alleged contraventions of the law.
In addition to these priority areas, we manage many individual compliance activities and investigations.
We also routinely monitor advertisements of therapeutic goods on digital platforms and social media sites. We may take compliance action on any non-compliance detected whether the matter falls within a compliance priority or not.
Further compliance priority areas may arise during the year and be added to this list.
There are a number of other compliance programs across our organisation that are not covered by this list, such as:
- compliance activities associated with complementary medicine listings
- monitoring and vigilance of medical device inclusions (medical devices post-market reviews)
- the pharmacovigilance and good clinical practice inspection programs
- the good manufacturing practice (GMP) compliance program
- software and AI medical device compliance.
Import, Advertising and Supply Compliance Priorities 2023-25
| Compliance Priority | Focus |
|---|---|
| Detect, deter and disrupt the unlawful import, advertising and supply of nicotine vaping products. | Australians are vulnerable to the risks associated with using nicotine vaping products without health professional oversight, with young Australians particularly at risk, in particular where the presence of nicotine is not declared in product advertising, labelling or packaging. We will dedicate resources to help ensure compliance with the Therapeutic Goods Act 1989 to complement proposed reforms to the regulation of vapes intended to help stamp out unsafe access to nicotine and other vaping products in 2023-25. We will:
continue to target unlawful advertising of nicotine vaping products to Australians including advertising of unapproved products on digital platforms. |
| Deter and disrupt unlawful advertising of medicinal cannabis, psilocybin and MDMA. | The public promotion of medicinal cannabis, psilocybin and MDMA to Australian consumers is illegal. The public promotion of these medicines may inappropriately influence demand, disrupt the relationship between patients and medical professionals, and bring disrepute to the industry. In addition to responding to high-risk allegations of non-compliance in the industry we will:
|
| Detect and disrupt unlawful supply and advertising of unapproved and high-risk medicines and medical devices used in the wellness and beauty industries including those intended to alter the body’s performance and appearance. | Australians seeking to enhance their physical performance or appearance may be vulnerable to advertisements promoting therapeutic goods as ‘health and beauty products’. These include sports supplements and weight loss medications, IV drips, cosmetic injectables and other medications or medical devices intended to alter the body’s appearance. In addition to responding to high-risk allegations of non-compliance regarding these products we will:
|
Detect, deter and disrupt the unlawful import and supply of substandard and falsified therapeutic goods with a particular focus on those products that declare, or otherwise are suspected to contain, higher risk substances that pose a risk to human health and/or safety.
| Australians seeking therapeutic results may be vulnerable to the sale of substandard and falsified therapeutic goods online or at physical locations by specialist retailers. Particular concerns arise where there is a lack of availability of a particular medicine, where it is perceived as a low-risk medicine, or where a medicine contains higher risk substances including Schedule 4 and Schedule 8 poisons. In addition to responding to high-risk allegations of non-compliance regarding these products we will:
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| Detect, deter and resolve the unlawful import, advertising and supply of medicines and medical devices advertised as traditional or alternative treatments, particularly those that contain substances that pose a risk to human health and/or safety. | Some Australians are vulnerable to those intent on profiting from the sale of unregistered therapeutic goods marketed as traditional or alternative treatments. This is of increased concern where the goods contain higher-risk substances including Schedule 4 and Schedule 8 poisons and heavy metals. Consumers that have or are facing a serious disease or condition with limited treatment options may be particularly vulnerable to advertising claims. In addition to responding to high-risk allegations of non-compliance regarding these products we will:
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