The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued three infringement notices totalling $7,992 to a Queensland man, for the alleged unlawful importation of a medicine containing Armodafinil.
The man allegedly imported tablets that were branded ‘Waklert’ that were not included in the Australian Register of Therapeutic Goods (ARTG).
Under the Therapeutic Goods Act 1989 (the Act), therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia (unless a specific exemption, approval or authority applies).
Armodafinil, a prescription only medicine, is often referred to as a ‘nootropic’ that promotes wakefulness and alertness. The TGA strongly advises consumers to be assessed by their doctor before taking any nootropic medicine. If your doctor decides that a nootropic medicine is a safe and appropriate treatment for your medical condition you will be given a prescription that can be filled at a pharmacy. Your doctor will also explain the potential side-effects of the medicine.
Nootropic medicines are also mistakenly referred to as ‘smart drugs’ (in name only). The TGA has published a warning about the off-label use of so-called ‘smart drugs’.
The use of medicines that are not in the ARTG can be a serious health risk to consumers. The TGA’s highest priority is to protect the health and safety of the Australian public through the regulation of therapeutic goods
The TGA takes action against breaches of the Act
It is illegal to buy or import prescription only medicines without a valid doctor’s prescription. If you do not provide the required evidence that an importation is lawful your goods may be destroyed.
The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods. The range of compliance and enforcement tools available include substantial fines and criminal or civil court action.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.