An overview of unapproved therapeutic goods

If you're planning to supply an unapproved therapeutic good in Australia, you must understand how we regulate unapproved therapeutic goods and what your obligations are under the supply pathways. 

Before supplying unapproved therapeutic goods, you are responsible for ensuring that an exemption, approval, or authority is in place. 

Being well-prepared helps ensure lawful supply and avoids regulatory delays. 

Start be reviewing your responsibilities and selecting the appropriate supply pathway. 

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all products.