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.
More information
- Mandatory requirements for an effective over-the-counter medicines application
- Australian regulatory guidelines for OTC medicines (ARGOM)
- OTC new medicines registration process
- OTC generic and originator medicines
- OTC application route for umbrella branded medicines
- OTC application categorisation framework
- Determining the correct application level required for OTC medicines submissions
- OTC new medicine N1 applications
- OTC N2 applications and OTC medicine monographs
- OTC dossier documents matrix