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The Therapeutic Goods Administration (TGA) has issued an infringement notice for $13,320 to WA-based company World Environmental Technologies Pty Ltd for alleged unlawful importation of ivermectin, a prescription-only medicine.
It is alleged that the company imported ivermectin tablets for human use into Australia which were not included in the Australian Register of Therapeutic Goods (ARTG). Prescription medicines require evaluation by the TGA and inclusion in the ARTG prior to supply to the Australian public before they can be lawfully imported unless an exemption applies.
There was no exemption provided in this case. Unregistered medicines have not been assessed for quality, safety or efficacy and pose a risk to consumers. Unregistered products could also be counterfeit.
To date no major regulator has approved ivermectin for the treatment of SARS-Cov 2 infection. The TGA's Advisory Committee for Medicines Scheduling has placed restrictions on the prescribing of ivermectin by general practitioners outside of approved indications. The TGA has also published advice on the risks of importing ivermectin for treatment of COVID-19 and on the new restrictions on prescribing ivermectin for COVID-19.
The TGA warns those considering importing unregistered therapeutic goods into Australia that they should comply with the applicable regulatory scheme. Importers who don't follow the requirements risk penalties including seizure of the products, fines and legal action.
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