TGA
The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice of $13,320 to Sydney-based company Arthropharm Pty Ltd (Arthropharm) for alleged contraventions of the Therapeutic Goods Act 1989 in relation to pharmacovigilance (activities monitoring the safety of medicines).
The infringement notices relate 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.