Post sponsored by NewzEngine.com

Source: Australian Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued eight infringement notices totalling $100,800 to Sydney-based company Shen Neng Herbal Medicines Group Pty Ltd (Shen Neng) for alleged contraventions of the Therapeutic Goods Act 1989 in relation to supply, labelling and pharmacovigilance (activities to ensure the safety of medicines).

The infringement notices relate to the alleged:

  • supply of goods that did not conform with a medicine labelling standard
  • supply of goods outside expiry date
  • failure to provide information on a contact person responsible for medicine safety
  • making a false or misleading statement to the TGA in relation to an application to include a therapeutic good in the Australian Register of Therapeutic Goods (ARTG).

“Shen Neng’s alleged non-compliance with the pharmacovigilance, supply and labelling requirements could pose a serious risk to consumer safety,” Adjunct Professor John Skerritt, Deputy Secretary of the Department of Health, said.

“The TGA has taken timely and decisive action to address these concerns and continues to work with Shen Neng to address issues relating to compliance with the therapeutic goods legislation.”

For listed medicines, the safety and effectiveness of a product is reliant on the responsible company (known as a ‘sponsor’) making accurate statements to the TGA about the ingredients in its product and correctly labelling the product.

The failure to include specific warning labels on particular products may mislead consumers and pose a risk to safety. Also, the supply of goods after the expiry date may mean a therapeutic good is not as effective as it should be, and at worst, might be harmful to a consumer.

Once a product enters the market, a pharmacovigilance system is necessary to detect, assess, understand and prevent adverse effects and other medicine-related problems. Notifying the TGA of a sponsor’s pharmacovigilance contact person is a key part of an effective and robust medicines safety system.

The TGA conducts checks and takes action against breaches of the Act

The TGA applies a risk management approach to ensure that medicines included on the ARTG meet acceptable standards. The TGA’s Pharmacovigilance Inspection Program was implemented as an initiative to help sponsors of medicines meet their pharmacovigilance obligations. Regular compliance reviews are also conducted to ensure that listed medicines uphold quality and safety standards.

The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.

If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.

Media enquiries: news@health.gov.au

MIL OSI News