Over-the-counter medicine applications are categorised according to risk. There are five risk levels for applications for new medicines (levels N1 to N5) and five risk levels for applications to make changes to existing medicines (levels CN to C4).
Each of these risk levels corresponds to an application category and a route to evaluation or, in the case of CN applications, directly to approval. Applications in lower risk levels require less supporting information than applications in higher risk levels.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.