Australia: 2022 – 2023 Will Be A Big Year For Medical Cannabis Compliance Says TGA

Here’s what they posted 12 July 2022

 

Import, Advertising and Supply Compliance Priorities 2022-23

12 July 2022

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 PriorityFocus
Deter and address the unlawful import, advertising and supply of unapproved therapeutic goods associated with COVID-19In 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:

  • continue to provide information to the community and to the therapeutic goods industry, including how to comply with the regulatory requirements
  • target alleged unlawful imports, advertising and supply, collaborating with other agencies as appropriate.
Disrupt and address the unlawful import, advertising and supply of nicotine vaping productsNicotine 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:

  • gather and use intelligence to identify non-compliance
  • collaborate with other health and law enforcement agencies to target and address unlawful imports
  • target unlawful advertising of nicotine vaping products to Australians.

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:

  • continue to engage with industry about their regulatory obligations

  • gather and use intelligence to identify non-compliance

  • target unlawful advertising, as well as supply where it is not in accordance with the requirements for unapproved goods.

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 poisonsAustralians 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:

  • provide education to the community about the dangers of taking unapproved products containing schedule 4 and 8 poisons
  • gather and use intelligence to identify non-compliance
  • target unlawful import, manufacture, advertising, compounding and supply of unapproved products, collaborating with other health and law enforcement agencies as appropriate
  • target online platforms advertising unapproved products.
Deter and address the unlawful import, advertising and supply of unapproved therapeutic goods used in the beauty and cosmetic dental industryThe 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:

  • target unlawful import and advertising of unapproved medicines and medical devices
  • liaise with Ahpra in matters that involve medical practice and procedures.
Address the unlawful use of restricted and prohibited representations in advertisements that have not been approved or permitted, particularly those that target especially vulnerable consumersConsumers 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:

  • focus on unlawful advertisements which make claims about therapeutic goods (including human cell and tissue products) that relate to a serious disease or condition and are not substantiated by robust evidence.
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 curesUnapproved 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:

  • work with relevant online stores and e-commerce platforms to remove advertisements which promote the illegal supply of unapproved therapeutic goods
  • work with relevant online stores and e-commerce platforms to remove advertisements which promote therapeutic goods for purposes that are inconsistent with the Australian Register of Therapeutic Goods
  • take enforcement action where appropriate including where serious or recidivist non-compliance is identified.

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