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The Therapeutic Goods Administration (TGA) has issued 6 infringement notices totalling $82,632 to Ovira Pty Ltd and an individual for the alleged unlawful advertising of an analgesic TENS system.
Ovira Pty Ltd allegedly advertised their analgesic TENS system for the treatment of several serious diseases, including endometriosis, without approval or permission from the TGA. References to serious forms of diseases in therapeutic goods advertising are restricted representations and prohibited under the Therapeutic Goods Act 1989 unless approved by the TGA.
The advertisements also allegedly claimed the analgesic TENS system is safe and suggested that competing therapeutic goods are harmful or ineffectual. This is alleged to be in contravention of the Therapeutic Goods Advertising Code.
Further information on the advertising of therapeutic goods can be found on the How to advertise section of the TGA website.
If you suspect non-compliance in relation to therapeutic goods or their advertising, you can report it to the TGA at any time.
Contact for members of the media:
- Email: news@health.gov.au
- Phone: 02 6289 7400