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
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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
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Safety alertsConsumers and health professionals should be aware that counterfeit Ozempic-labelled pens have been imported into Australia. These pens may pose a serious health risk and should not be used. There are clear inconsistencies from the original product to look out for.
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Safety alertsWe have become aware of an increasing number of cases of liver injury reported in scientific literature, by consumers who had taken products containing Garcinia gummi-gutta.
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Safety alertsRobust Extreme capsules pose a serious risk to your health and should not be taken.
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Product Information safety updates - September 2024
Safety updatesInformation for health professionals about medicines with safety related updates to their product information.
Latest publications
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PublicationsFind out about the seasonal influenza vaccines available for the 2024 southern hemisphere season.
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PublicationsMDSU provides practical advice and information about medical device safety.
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Scheduling decisions (interim)Interim decisions and invitation for further comment. Closing date: 3 March 2023
Resources
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Compositional guidelinesCompositional guideline for Akkermansia muciniphila strain ATCC BAA-835 permitted for use in listed medicines.
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Reference materialWe review the Permissible Ingredients Determination to ensure the ingredients are safe for use in low-risk medicines.
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Reference materialInformation on how to interpret Essential Principle 13B and how it applies to your device.
Latest consultations
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Closes onConsultationThe TGA is seeking feedback on proposed changes to the regulation of assistive technologies.
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Closed onConsultationThe TGA is seeking feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
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Closed onConsultationThe TGA is seeking feedback from interested parties on the proposed changes to replace the sunsetting TGO 70C with a new instrument