How we regulate

Find out how a company, sponsor or applicant can legally sell or supply a therapeutic good in Australia.  We have different processes for prescription and non-prescription medicines, biologicals, medical devices and other therapeutic goods. As part of the process you should set up a TGA Business Services account.

There are strict rules around manufacturing, ingredient use and names, what you need on your label and what you can and cannot advertise. You must meet our standards and requirements for therapeutic goods supplied in Australia.

Visit our compliance hub to find out about fines and prosecutions, and when we might cancel a therapeutic good from the Australian Therapeutic Goods Register. If your product has a safety issue or shortage there are steps you must take.