Overview of over-the-counter (OTC) medicine registration

Applications to register an over-the-counter (OTC) medicine are categorised into five levels based on risk, as follows:

• Lower risk levels include applications to register OTC medicines that contain well-understood active ingredients or are identical to existing OTC medicines.
• Higher risk levels include more complex applications such as medicines with new active ingredients or new indications.

The OTC application levels have defined timelines and submission requirements. Less supporting information is required and shorter target times apply to lower risk level applications.

Applications must be submitted electronically through our Business services. The application dossier must be in Common Technical Document (CTD) format.

After we receive an application to register an OTC medicine, we screen the application to determine whether it is complete and meets the requirements for an effective application. If the application is effective, it is accepted for evaluation.

During evaluation, we may make requests for information from the applicant to address issues that we have identified.

Following evaluation, the decision maker (the delegate of the secretary) decides whether to register the medicine on the Australian Register of Therapeutic Goods (ARTG).

Guidance

See our step-by-step guide on how to apply to register an OTC medicine.

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