About market authorisation
Market authorisation is the approval companies need to supply therapeutic goods, such as medicines and medical devices, in Australia.
The market authorisation process ensures that new therapeutic goods:
- are safe
- perform as intended
- meet appropriate standards for use in Australia.
The Therapeutic Goods Administration (TGA; part of the Department of Health) is responsible for market authorisations. It evaluates, assesses and monitors therapeutic goods.
If the TGA approves a new item as safe and effective, it enters the item on the Australian Register of Therapeutic Goods (ARTG). The ARTG is an electronic register of therapeutic goods that are available for use in Australia.
Companies can then legally sell the item in Australia.
The TGA’s regulation essentials has more on how companies can meet their obligations if they are looking to import, supply, export or manufacture a therapeutic good.
Reasons to apply
If a company’s product is a therapeutic good, the company must apply for market authorisation before it can sell the product in Australia.
Products must have market authorisation before they can undergo a health technology assessment (HTA) for Australian Government subsidy.
The TGA have a series of interactive decision tools that can help companies decide if their products are regulated as a therapeutic good or medical device.
Process
See the TGA for an overview of applying for market authorisation.
For medicines, vaccines and medical devices, the market authorisation assessment can be carried out at the same time as the application for Australian Government subsidy (parallel processing).
Next steps
Once a product is registered on the ARTG, it may also be eligible for government subsidy under programs such as the Medicare Benefits Schedule or the Pharmaceutical Benefits Scheme.
See HTAs for Australian Government subsidy.
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