OTC new medicines registration process
This guidance is intended to assist applicants to register a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).
The following webpages:
- identify the regulatory process you need to follow
- navigate you through the process step-by-step
- link to relevant guidance and forms.
Steps in the OTC registration process
- Verifying your OTC medicine and access to Business services
Skip this step if you have already determined that you have:
- an OTC medicine that requires registration
- access to Business services.
- Checking for new medicine ingredients
- Determining your application level
- Checking guidelines and mandatory requirements
- Ensuring valid GMP evidence
- Compiling data for your application
- Completing and submitting your application
- Paying your fees
- Screening your application
- Evaluating and requesting information
- Making the OTC registration decision
- Finalising your OTC registration