Here’s what they posted 12 July 2022
Import, Advertising and Supply Compliance Priorities 2022-23
The table below sets out the TGA’s priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 1 July 2022 to 30 June 2023.
They should be read in conjunction 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 the priority areas, the TGA manages many individual compliance activities and investigations.
Further compliance priority areas may arise during the year and be added to this list.
There are a number of other compliance programs across the TGA that are not covered by this list, such as compliance activities associated with complementary medicine listings, monitoring and vigilance of medical device inclusions, the pharmacovigilance and good clinical practice inspection programs, and the GMP compliance program.
Import, Advertising and Supply Compliance Priorities 2022-23
| Compliance Priority | Focus |
|---|---|
| Deter and address the unlawful import, advertising and supply of unapproved therapeutic goods associated with COVID-19 | In the context of the COVID-19 pandemic it is important that therapeutic goods associated with the prevention, diagnosis and treatment of COVID‑19 infections have been appropriately approved for supply in Australia, and that the illicit import, advertising and supply of unapproved goods is addressed.
We will:
|
| Disrupt and address the unlawful import, advertising and supply of nicotine vaping products | Nicotine vaping products may be lawfully prescribed for smoking cessation purposes, however these products are also being illegally imported and advertised in Australia leading to inappropriate access to the products.
All Australians are vulnerable to the risks associated with using these products without health professional oversight, with young Australians particularly at risk of vaping becoming a gateway to smoking. We will:
|
Ensure compliance with the requirements of the Therapeutic Goods Act 1989 across the medicinal cannabis industry |
The public promotion of medicinal cannabis, as a prescription medicine, to Australian consumers is illegal. The public promotion of prescription medicines can inappropriately influence demand and disrupt the doctor/patient relationship.We will:
|
| Disrupt and address the unlawful import, manufacture, advertising and supply of unapproved performance and image enhancing therapeutic goods, including sports supplements, with a focus on products containing schedule 4 and 8 poisons | Australians seeking to enhance their physical performance and body shape may be vulnerable to those seeking to take advantage of them through the supply of unlawful performance and image enhancing products.
Consumers may be inappropriately driven to health harming products containing scheduled and/or prohibited ingredients. We will:
|
| Deter and address the unlawful import, advertising and supply of unapproved therapeutic goods used in the beauty and cosmetic dental industry | The demand for therapeutic goods used in the beauty industry is not expected to decline. Consumers expect that the therapeutic goods used in beauty and cosmetic procedures have been subject to Australian regulatory controls.
We will:
|
| Address the unlawful use of restricted and prohibited representations in advertisements that have not been approved or permitted, particularly those that target especially vulnerable consumers | Consumers that have or are facing a serious disease or condition that may have limited treatment options can be particularly vulnerable to advertising claims.
We will:
|
| Deter and address the unlawful advertising of unapproved therapeutic goods on e-commerce platforms; including for pregnancy and prenatal goods, weight loss products and hangover cures | Unapproved complementary medicines are being advertised and sold through online stores and ecommerce platforms, some of which use unlawful testimonials and unsubstantiated claims to advertise the products.
We will:
|
