The Therapeutic Goods Administration (TGA) has issued two infringement notices totalling $26,640 to Queensland based company TMF Cosmeceuticals Pty Ltd (TMF Cosmeceuticals) for alleged unlawful importation of ivermectin, a prescription-only medicine.
It is alleged that on two occasions TMF Cosmeceuticals imported oral ivermectin tablets for human use into Australia which were not included on the Australian Register of Therapeutic Goods (ARTG) at the time of importation. Therapeutic goods must be entered in the ARTG before they can be lawfully imported unless an exemption applies.
Unregistered medicines have not been assessed for quality, safety or efficacy and pose a risk to consumers. Unregistered products could also be counterfeit.
While clinical trials are being conducted globally, to date there has been minimal evidence to support the use of ivermectin for the treatment of COVID-19. The TGA’s Advisory Committee for Medicines Scheduling placed restrictions on the use of ivermectin outside of the indications on the ARTG. This was in response to:
- the inappropriate use of ivermectin for COVID-19 causing a shortage of the product for those patients who need it for its approved indications,
- misinformation about ivermectin often recommending high doses which pose health risks to consumers. High doses can be associated with serious adverse effects including severe nausea, vomiting, dizziness, and neurological effects such as seizures and coma.
The TGA has 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 be aware of and comply with the applicable regulatory scheme. Importers who don’t follow the requirements risk financial penalties including seizure of the products, fines and other legal action as appropriate.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.