You will need this licence if you intend to market therapeutic goods or biologicals as an individual or organisation under your own name or brand. This covers any drug or device used for the prevention, diagnosis or treatment of diseases or other bodily functions. Registrable products include prescription or non-prescription medicines, and implantable medical devices, such as active implantables, and devices of animal origin.
Listable goods include:
- herbal medicines
- most medical devices.
Therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. The ARTG is a database of information about therapeutic goods for human use approved for supply in, or exported from, Australia. Information held on the database includes the product name and formulation details and sponsor and manufacturer details.
Application for registration or listing of an item may include additional information to be accompanied by the application. Please refer to relevant guidelines or legislative instruments.