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I think I have an over-the-counter (OTC) medicine
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Based on the answers you have given your product may be an over-the-counter (OTC) medicine and a regulated therapeutic good. You can find out more about OTC medicines on the over-the-counter medicine webpage or on the OTC regulation page.
Overview
Over-the-counter medicines (OTC) are medicines that are not prescription medicines and are not complementary medicines. OTC medicines can be supplied as:
- pharmacy medicines (included in Schedule 2 to the Poisons Standard)
- pharmacist-only medicines (included in Schedule 3 to the Poisons Standard)
- general sales medicines that are not included in any of the schedules to the Poisons Standard.
Useful links
If you are new to therapeutic goods regulation you should also familiarise yourself with:
- Overview of supplying therapeutic goods in Australia
- A summary of supplying therapeutic goods in Australia (video)
- Excluded therapeutic goods
- Responsibilities of becoming a sponsor in Australia
- Fees and charges
- Advertising and labelling and packaging requirements
Next steps
Once you have familiarised yourself with the information at the above links, you may wish to apply to have your over-the-counter medicine to be entered in the Australian Register of Therapeutic Goods (ARTG). If so, you should:
- Consider engaging a regulatory affairs consultant
- Create a TBS account
- Gather the documents you will need to support your application to enter your medicine on the ARTG.