Based on the answers you have given your product may be a generic prescription medicine and a regulated therapeutic good. Generic prescription medicines follow a similar process to other prescription medicines. You can find out more on the Australian Regulatory Guidelines for Prescription Medicines webpage or on the generic prescription medicines fact sheet.
Overview
A generic medicine is an additional brand of an existing prescription medicine. It contains the same active ingredient as the existing medicine and must be bioequivalent. Examples include contraceptive pills, antibiotics and strong painkillers.
Useful links
If you are new to therapeutic goods regulation you should also familiarise yourself with:
- Prescription medicines medical products regulation
- Generic prescription medicines fact sheet
- 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 enter your generic prescription medicine on 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.