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 andall products.
An overview of over-the-counter medicines
Start here to get an overview of how your product is regulated and helpful information to support your journey.
Regulation of over-the-counter medicines
Know your obligations at each point along your product’s regulatory journey.
Application and market authorisation
Guidance and other information on the application process, including evaluation processes and fees, for over-the-counter medicines.
Supply and distribution
Find requirements for the ongoing supply, import, export, storage and handling of over-the-counter medicines.
Labelling and advertising
Information about labelling, packaging and advertising for over-the-counter medicines,
Monitoring and compliance
Manage your over-the-counter medicines after registration, including updates, reporting, and safety monitoring.
Latest alerts
- Market actionsSeveral vitamin and perinatal (including preconception) products are being recalled due to a lack of or excessive levels of potassium iodine.
- Safety alertsThe oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be given to children under 6 years of age.
- Safety alertsThe TGA has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna).
Articles
- BlogIn many cases, pharmacists and prescribers are able to provide or prescribe another approved medicine that is on the Australian Register of Therapeutic Goods (ARTG) or they can give a different strength or dosage of the same medicine.
- BlogLike all goods available in Australia, therapeutic goods can sometimes experience problems. When this happens, we decide if a ‘market action’ is needed. A market action aims to correct the problem. There are four types of market actions you should be aware of.
- BlogWe know that paracetamol is safe and effective for most people when taken at the recommended dose.
Latest publications
- Scheduling decisions (final)On 3 May 2023, the TGA announced the final decision to amend the scheduling of paracetamol in the Poisons Standard.
- Meeting statementsAdvisory Committee on Medicines meeting statement, Meeting 31, 3-4 February 2022
- Meeting statementsAdvisory Committee on Medicines, meeting statement now available