The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued four infringement notices totalling $53,280 to Sydney-based company Shen Neng Herbal Medicines Group Pty Ltd (Shen Neng) for alleged contraventions of the Therapeutic Goods Act 1989 (the Act) in relation to breaching a condition of listing and failing to provide information to the TGA when required to do so.
The listed medicines framework allows sponsors to supply low-risk complementary (listed) medicines to consumers without pre-market approval, provided certain conditions specified in the Act are met. It is alleged Shen Neng failed to comply with a condition of listing by failing to notify the TGA of the manufacturer of two of their medicines within the required timeframe. Failure to comply with a condition of listing reduces confidence that the safety, quality and efficacy of listed medicines are maintained at an appropriate standard.
Shen Neng also allegedly failed to comply with two notices from the TGA requiring it to provide information in relation to its medicines. Under the Act, sponsors of listed medicines must provide information requested within specified timeframes to allow the TGA to conduct post-market compliance reviews of their medicines.
Post-market compliance reviews are one of the key processes the TGA uses to ensure listed medicines meet safety, quality and efficacy requirements under the Act. Timely responses are therefore critical to the ongoing compliance of listed medicines.
Shen Neng was previously fined $100,800 in October 2020 for alleged breaches of the Act in relation to supply, labelling and pharmacovigilance.
The TGA takes action against breaches of the Act
The listed medicines framework is critical to providing Australian consumers with safe and effective listed medicines. Sponsors are reminded that medicines listed on the Australian Register of Therapeutic Goods (ARTG) must comply with requests for information under the Act, as well as with all other relevant provisions, including conditions of listing.
Conduct that undermines the listed medicines framework is of significant concern to the TGA, particularly where it has the potential to adversely affect consumer health and safety. In such circumstances, the TGA will consider imposing financial penalties.
If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.
