The Therapeutic Goods Administration (TGA) has issued 2 infringement notices totalling $26,640 to Queensland based company Nius Development Pty Ltd for the alleged unlawful import of unapproved cosmetic injectable products.
It is alleged that the company attempted to import medical devices containing prescription only substances, without approval or authority. The cosmetic injectable products contained hyaluronic acid and lidocaine. Equivalent products are readily available in Australia.
Injection with unapproved cosmetic injectable products comes with an increased risk of adverse events. These allegedly illegally imported products were not on the Australian Register of Therapeutic Goods (ARTG), are not approved for supply in Australia, have not been reviewed for safety or quality, and therefore pose an unacceptable risk to consumers.
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. Unregistered products do not come with these assurances.
Businesses must understand their legal obligations prior to importing therapeutic goods. Consequences for non-compliance with relevant laws include not only financial penalties, but also civil or criminal proceedings being brought against you.
Consumers and patients can read our information on cosmetic injections and use our cosmetic injections checklist before engaging with a business. They should ensure the business they engage:
- have appropriate credentials to provide the service
- only supply prescription products after a consultation with a suitably qualified health practitioner who has assessed whether the products are right for each patient
- only supply 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 or suspected non-compliant advertising online to the TGA.
Contact for members of the media:
- Email: [email protected]
- Phone: 02 6289 7400
