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The TGA has issued 2 infringement notices totalling $7,512 to a Victoria-based nurse for allegedly importing unapproved prescription-only and cosmetic injectable products.
These included botulinum toxin type A vials and pre-filled syringes containing hyaluronic acid. The medicines and medical devices have been seized at the border and will not be released.
The individual did not have approval or authority to import these products, and these products are not on the Australian Register of Therapeutic Goods (ARTG). This means that they are not approved for supply in Australia, have not been reviewed for safety or quality, and pose an unacceptable risk to consumer health. Unapproved cosmetic injectable products come with an increased risk of side effects.
In the past 12 months the TGA has issued infringement notices totalling more than $50,000 to 5 health practitioners and a company who attempted to import unapproved prescription-only products outside lawful access pathways for medicines and medical devices.
The TGA continues to work with Australian Border Force to prevent the illegal importation of these products.
All prescription-only products on the ARTG have been assessed by the TGA to ensure they meet quality standards, including that they are sterile, contain only the labelled ingredients, and were manufactured in a suitable facility. Unapproved products do not come with these assurances.
Businesses must understand their legal obligations prior to importing, advertising, or supplying therapeutic goods. Consequences for non-compliance with relevant laws may include not only financial penalties, but also civil or criminal proceedings.
Consumers and patients can read our information on cosmetic injections and use our cosmetic injections checklist before engaging with a business. Consumers should ensure the business they engage with:
- has appropriate credentials to provide the service
- only supplies prescription products after a consultation with a suitably qualified health practitioner who has assessed whether the products are right for each patient
- only supplies products that are approved for supply and use in Australia (are on the ARTG).
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
Contact for members of the media:
- Email: news@health.gov.au
- Phone: 02 6289 7400