Evidence needed for indications

Sponsors must hold evidence to support any indications and claims they make about their product. 

You need to have this information at the time you apply to list or register your medicine in the ARTG and for the whole time it is entered in the ARTG. 

Indications: 

• are statements that specify the therapeutic use of the goods 

• must be included in the ARTG entry for the medicine 

• must be supported by evidence

Claims:

• do not convey a specific therapeutic benefit (for example, ‘25% more’ or ‘new formula’)

• do not need to be included in the ARTG; but 

• must be supported by evidence 

Different indications require different types of evidence.