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The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice of $13,320 to Perth-based company Kardwi Pharmaceuticals Pty Ltd (Kardwi) for alleged contraventions of the Therapeutic Goods Act 1989 in relation to pharmacovigilance (activities monitoring the safety of medicines).
The infringement notice relates to the alleged failure to provide information on a contact person responsible for medicine safety.
Once a product enters the market, a pharmacovigilance system established by the responsible company (known as 'medicine sponsor') 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 requirement under the Therapeutic Goods Act 1989 and is an integral 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 medicines uphold quality and safety standards.
The regulatory scheme is critical to the safety of Australian patients 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