Non-prescription medicines are comprised of complementary medicines and over-the-counter medicines, including sunscreens.
There are the following types of non-prescription medicines:
- listed medicines
- assessed listed medicines
- registered complementary medicines
- over-the-counter (OTC) medicines.
These are categorised on the ingredients they contain and therapeutic indications (claimed health benefits) they use.
-
PageMake sure your supplement, vitamin or complementary medicine is regulated as a non-prescription medicine
-
PageOverview of the application process for the different types of non-prescription medicines.
-
PageFind out what standards and requirements you must comply with to legally sell or supply your medicine in Australia.
-
ServiceOutline of the process for entering your non-prescription medicine onto the Australian Register of Therapeutic Goods.
-
PageLearn about your on-going responsibilities once your non-prescription medicine is on the Australian Register of Therapeutic Goods.
-
PageReforms for non-prescription medicines.
Discuss your application with us
If you need further guidance before submitting your non-prescription medicine application, a pre-submission meeting may help address issues you're unclear about.
Read more about pre-submission meetings with TGA.
More information
- An overview of the regulation of complementary medicines in Australia
- Pathways to evaluating your medicine
- Changes to nappy rash products
- Submitting data in the eCTD format
- Submitting data in the NeeS format
- Pathways for complementary medicine products
Sunscreens
Inhalation and nasal sprays
Listed and registered medicines
- Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines
- Notifications process: registered medicines
- Listed complementary medicines
- What do I require to have a listed medicine in the ARTG?
- Information on our proposed updated evidence guidelines for listed medicines
- Information on our proposed updated evidence guidelines for listed medicines - 28 March
- Webinar presentation: Information session on the revised evidence guidelines for listed medicines, 23 March 2022
- Mandatory requirements for an effective registered complementary medicine application
- Overview of the regulation of listed medicines and registered complementary medicines
- Other resources for sponsors of listed medicines and registered complementary medicines
Assessed listed medicines
- Assessed listed medicines
- Assessed listed medicines pathway for complementary medicines
- Assessed listed medicines pathway: frequently asked questions
Over-the-counter medicines
- Australian Regulatory Guidelines for OTC medicines (ARGOM)
- OTC new medicines registration process
- Process to change a registered OTC medicine
- Approved manner of making an application under section 23 of the Therapeutic Goods Act 1989 for a registered OTC medicine
- ARGOM Appendix 2: Guidelines on quality aspects of OTC applications
- Requirements for OTC new medicines N2 applications (using OTC medicine monographs)
- Mandatory requirements for an effective over-the-counter medicines application
Latest alerts
-
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 alertsAfrican Vigorous Max Strength poses a serious risk to your health and should not be taken.
-
Safety alertsWe have tested a further 6 imported, unregistered ivermectin products and found they are counterfeit under the Therapeutic Goods Act 1989.
Latest articles
-
Product Information safety updates - November 2024
Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information. -
Promethazine hydrochloride (Phenergan) not to be used in children under 6
Safety updatesHealth professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age. -
Shingrix vaccine and very rare risk of Guillain-Barré Syndrome
Safety updatesWe have received Australian reports of Guillain-Barré Syndrome (GBS) following Shingrix vaccination.
Latest publications
-
Meeting statementsAdvisory Committee on Medicines meeting statement
-
PublicationsWe commissioned the Health Design Lab to conduct market research to better understand the individual consumer, pharmacist and prescriber experiences of shortages and discontinuations.
-
Meeting statementsAdvisory Committee on Medicines meeting statement
Resources
-
Reference materialThe TGA has investigated potential safety issues with complementary medicines with soft gel capsule dosage forms
-
-
Reference materialUpdated frequently asked questions to inform sponsors about discontinuing the pre-market evaluation of HCNs.
Latest consultations
-
ConsultationWe are seeking feedback on proposed improvements to TGA’s regulatory framework for medicine shortages and discontinuations in Australia.
-
ConsultationThe TGA is seeking feedback on proposed changes to the regulation of assistive technologies.
-
ConsultationThe TGA is seeking feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.