Australia: Import, Advertising and Supply Compliance Priorities 2022-23

Medication tablets

The TGA has published a list of import, advertising, and supply compliance priorities from I July 2022 to 30 June 2023:

  1. Deter and address the unlawful import, advertising, and supply of unapproved therapeutic goods associated with COVID-19.
  2. Disrupt and address the unlawful import, advertising, and supply of nicotine vaping products.
  3. Ensure compliance with the requirements of the Therapeutic Goods Act 1989 across the medicinal cannabis industry
  4. 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.
  5. Deter and address the unlawful import, advertising, and supply of unapproved therapeutic goods used in the beauty and cosmetic dental industry.
  6. Address the unlawful use of restricted and prohibited representations in advertisements that have not been approved or permitted, particularly those that target especially vulnerable consumer
  7. 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.

In relation to item 4, the TGA proposes to focus on the import, manufacture, advertising, compounding, and supply of unapproved products. This will be accompanied by consumer education and targeting of online platforms advertising unapproved sports supplements.

In relation to item 6, the TGA will focus on unlawful advertisements that relate to serious diseases or conditions where the Sponsor does not hold suitable evidence for the indication and has not entered the indication on the Australian Register of Therapeutic Goods.

In relation to item 7, the TGA has identified unapproved Complementary Medicines being advertised and sold through online platforms and those which include unlawful testimonials and unsubstantiated indications. The compliance activities will include monitoring for unapproved therapeutic goods, approved therapeutic goods with unapproved indications and claims, and unlawful testimonials which do not comply with the Therapeutic Goods Advertising Code. Focus areas are pregnancy, prenatal care, weight loss, and hangover cures.

Further compliance priority areas may arise during the year and be added to the list. These priorities are in addition to the regular TGA compliance programs for Complementary Medicine listings (post-market reviews), monitoring and vigilance of medical device inclusions, pharmacovigilance and good clinical practice inspection programs, and the GMP compliance program.

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