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Supply a non-prescription medicine
Information on how to supply a non-prescription medicine.
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
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Latest publications
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Meeting statementsAdvisory Committee on Complementary Medicines meeting statement for 14 March 2024
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Scheduling decisions (final)This web publication constitutes a notice for the purposes of regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations).
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Meeting statementsAdvisory Committee on Medicines meeting statement
Resources
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/410/01 Rev. 3
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/QWP/158/01 Revision, EMEA/CVMP/115/01 Revision
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ConsultationWe are seeking feedback on whether 19 international scientific guidelines should be adopted.
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ConsultationWe are seeking feedback on proposed improvements to TGA’s regulatory framework for medicine shortages and discontinuations in Australia.
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ConsultationThe TGA sought feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.