The Therapeutic Goods Administration (TGA), which is a part of the Australian Government Department of Health and Ageing, administers the following legislation:
This legislation regulates the manufacture, supply and advertising of therapeutic goods (health products) in Australia to ensure they are safe and fit for their intended purpose.
Therapeutic goods include medicines (whether prescribed by a doctor, recommended by a pharmacist or bought at a supermarket) and medical devices.
Most therapeutic goods must be entered on the Australian Register of Therapeutic Goods before they can be supplied in Australia. However, there are some goods which are exempt altogether from being entered on the register, some which may be listed only and others which must be registered.
Listed goods are considered to be lower risk and are not evaluated; they are presumed to be safe and sponsors can make any claims about their use and effect as long as they do not breach the Therapeutic Goods Advertising Code 2007 (Cth). Sponsors must certify that they hold evidence to support any claims they make in relation to the goods and that those claims are substantiated. Registered goods, by contrast, are evaluated for safety and effectiveness by independent expert advisory committees of the TGA.
Most therapeutic goods must be accompanied by consumer information stating what the goods are used for and how they work, contraindications, precautions and possible side-effects, guidelines for proper use and storage and unwanted effects or overdose and what to do in such situations.
The TGA may require a sponsor to recall goods if faults are detected. Faults may include that the goods do not conform to standards or that they do not meet licensing, listing or registration requirements. Alternatively the TGA may require a sponsor to inform the public that a fault has been detected or publish specific information about the product.
The Australian and New Zealand Governments signed an Agreement for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products on 10 December 2003 and on 20 June 2011 the respective Prime Ministers signed a statement of intent to implement the agreement over a period of up to five years.
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