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This user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription over-the-counter (OTC) medicine.
The following pages:
- identify the regulatory process you need to follow
- navigate you through the process, step by step
- hyperlink to relevant guidance and forms.
Steps in the process
- Verifying your change requires prior approval from the TGA
- Determining your application level and change codes
- Checking relevant guidelines and requirements
- Obtaining an ID number for new proprietary ingredients
- Skip this step if you are not including a new proprietary flavour, fragrance, ink or colour in the medicine
- Ensuring GMP evidence is valid
- Compiling data for your application
- Changing more than one medicine
- Skip this step if you only want to change one medicine
- Completing and submitting your application
- Paying your fees
- Screening your application
- Evaluating and requesting information
- Making the decision
- Finalising your application