The therapeutic goods regulatory framework allows sponsors to supply low risk listed medicines to consumers without pre-market approval, provided certain regulatory requirements specified in the Therapeutic Goods Act 1989 (Cth) (the Act) are met.
Under the Act, sponsors of listed medicines must provide the required information in the specified form and timeframe, and must ensure that the information they provide is not false or misleading. This allows the TGA toconduct post-market investigations and compliance reviews of listed medicines to ensure ongoing compliance. As such, timely responses allow sponsors to demonstrate they meet their legal obligations and align with the TGA’s post-market compliance activities.
Sponsors must understand their legal obligations prior toincluding 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 and the compliance activities undertaken by the TGA.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
