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An overview of medicines

Start here for an overview of how your medicine is regulated and the steps involved to bring it to market. 

If you're planning to bring a medicine to market in Australia, this is your starting point.   
 

You need to understand how we regulate these products and your obligations at each stage. This includes choosing the right pathway, preparing evidence and meeting product standards.  
 

Being well prepared helps ensure your product meets Australian requirements and avoids delays getting it to market.  
 

Start by learning your responsibilities and planning each stage of your product’s lifecycle.  
 

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

 

Product types