Determining the correct application level required for over-the-counter (OTC) medicines submissions

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.

1. All intending sponsors should be familiar with the OTC application categorisation framework already mentioned above before proceeding to step 3 or 4.
2. For umbrella branded medicines, sponsors should also consult the guidance: OTC application route for umbrella branded medicines.
3. (For those who are familiar with the risk based application category framework) use the OTC application placement flowchart.
4. (For those who are not familiar with the risk based application category framework) use the OTC application placement question and answer tool.

Other useful information and tools

• OTC new medicine registration process
• Process to change a registered OTC medicine
• Target times (expected evaluation timelines for the different application categories