The Therapeutic Goods Administration (TGA) has issued five infringement notices in the amount of $82,500 to the New South Wales based company Caruso’s Natural Health Pty Ltd, for an alleged failure to hold information or evidence to support five therapeutic uses in relation to three medicines.
The therapeutic goods regulatory framework allows sponsors to supply certain low risk listed medicines to consumers without pre-market assessment of efficacy, quality and safety by the TGA. This is dependent on meeting certain regulatory requirements specified in the Therapeutic Goods Act 1989 (Cth) (the Act).
Under the Act, sponsors of those listed medicines must, at all times, hold information or evidence that supports each therapeutic use for their medicine. In the absence of premarket scrutiny, this ensures that consumers can obtain timely access to listed medicines that are efficacious. Failure to hold information or evidence that supports the therapeutic uses for a listed medicine undermines the regulatory framework, potentially exposing consumers to avoidable risk.
Sponsors must understand their legal obligations prior to including listed medicines in the Australian Register of Therapeutic Goods (ARTG), and must ensure that their listed medicines comply with the applicable legislative requirements at all times. Consequences for non-compliance with relevant laws may include not only cancellation from the ARTG and financial penalties, but also civil or criminal proceedings.
The Compliance and enforcement hub includes further information about the compliance actions that are available to the TGA to address non-compliance, as well as the compliance activities undertaken by the TGA. Further information about how the TGA conducts reviews of listed medicine compliance can be found at Listed medicine compliance reviews.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
