OTC 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 OTC application categorisation framework defines the different OTC medicine applications levels and the key application criteria. This is recommended as the first reference for an applicant for familiarisation with the risk framework and corresponding application categories that are available.
An application for a new or changed OTC medicine must be submitted at the correct risk level. In order to determine the correct risk level / application category a suite of guidance tools are available, and the following sequence of steps is recommended.
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.