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.
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PageMake sure your supplement, vitamin or complementary medicine is regulated as a non-prescription medicine
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PageOverview of the application process for the different types of non-prescription medicines.
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PageFind out what standards and requirements you must comply with to legally sell or supply your medicine in Australia.
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ServiceOutline of the process for entering your non-prescription medicine onto the Australian Register of Therapeutic Goods.
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PageLearn about your on-going responsibilities once your non-prescription medicine is on the Australian Register of Therapeutic Goods.
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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
- Requirements for OTC new medicines N2 applications (using OTC medicine monographs)
Latest alerts
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Market actionsKmart Australia Ltd is recalling their Anko Small Gel Pak and Anko Large Gel Pak because they contain ethylene glycol, a toxic substance.
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Market actionsThe company which has supplied the CellAED devices, RRR Manufacturing Pty Ltd, has gone into liquidation. The liquidators for RRR Manufacturing, are conducting a Critical Recall for all lots of the CellAED device.
Latest articles
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Conviction for unlawful supply and advertising of black salve products
Media releasesAn individual has been sentenced for unlawfully advertising and supplying black salve and bloodroot capsules, and for advertising other unapproved therapeutic goods to treat serious conditions such as anxiety. -
Product Information safety updates - January 2026
Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information. -
Product Information safety updates - December 2025
Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
Latest publications
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Meeting statementsCommunique from the 11th meeting of the Women's Health Products Working Group, 30 October 2025
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Meeting statementsAdvisory Committee on Vaccines meeting statement 54
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Meeting statementsMedical device reforms: Consumer Working Group meeting statement, Meeting 17, 22 August 2025
Resources
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FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
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FormsTemplates to help you with your communications under the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
Latest consultations
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ConsultationThis consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
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ConsultationHave your say about proposed changes to address 3 medicine safety matters needing action, before we review labelling rules more broadly.