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About OTC medicines
Over-the-counter (OTC) medicines are non-prescription products such as pain relievers, cold remedies, and allergy treatments. Some are available in supermarkets; others are only available in pharmacies and others require a consultation with a pharmacist.
Most OTC medicines are registered on the Australian Register of Therapeutic Goods (ARTG). You must provide a dossier with evidence of safety, quality and efficacy before supply.
We carefully assess these medicines before they reach the market and monitor safety after supply. You are responsible for following legislative requirements for their legal supply.
Some low-risk OTC medicines may be listed on the ARTG, e.g. throat lozenges. They are regulated in the same way as any other listed medicine.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to over-the-counter medicines. You may also have to meet obligations that apply to all medicines and all products.
