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.
- PageConfirm you have a non-prescription medicineMake sure you have a non-prescription medicine and not a food, sports or cosmetic product
- PageOverview of application process for non-prescription medicinesOverview of the application processes for non-prescription medicines
- PageConfirm the type of non-prescription medicineConfirm the type of non-prescription medicine you have
- PageConfirm the application level of your non-prescription medicineFind out how to choose the right category for your non-prescription medicine application.
- PageIngredient requirements for non-prescription medicinesIngredient requirements for non-prescription medicines
- PageUsing indications for non-prescription medicinesUsing indications for non-prescription medicines
- PageManufacturing information for non-prescription medicinesManufacturing information for non-prescription medicines
- PageLabelling, packaging and promotion of non-prescription medicinesLabelling, packaging and promotion of non-prescription medicines
- PageCompile and keep evidence for your non-prescription medicineCompile and keep evidence for your non-prescription medicine
- PageSubmit an application for a non-prescription medicineSubmit an application for a non-prescription medicine.
- PageVary your ARTG entry for a non-prescription medicineVary your Australian register of therapeutic goods (ARTG) entry for your non-prescription medicine
- 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
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
- 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
- GuidanceExport of medicines from AustraliaThis guidance is to assist with exporting medicines either for commercial supply, or for non-commercial purposes.
- GuidanceNotifications process: requests to vary registered medicines where quality, safety and efficacy are not affectedOutlines types of variations that have been determined to pose a very low risk.
- Safety alertsMultani Kaminividravana Rasa (Kamini) tabletsThe TGA has recently tested the contents of Kamini, and found ingredients in Kamini that pose a serious risk if ingested.
- Medicine shortage alertsAntibiotics shortage update and new guidance for health professionalsWe have updated the information about these shortages with new details about affected products and a link to an additional resource for health professionals.
- Safety alertsEVE Allylisopropylacetylurea tabletsThe TGA is warning consumers against taking EVE branded products that contain allylisopropylacetylurea (apronal) as they pose a significant health risk and are prohibited from sale, supply or use in Australia.
- Safety updatesProduct Information safety updates - April and May 2023Medicines Safety Update - Information for health professionals
- BlogDo you read the label every time?Check the labels of all medicines and medical devices, including those you buy without a doctor’s prescription.
- Media releases2023 Seasonal Influenza VaccinesInfluenza vaccines can change from year to year as new strains of influenza virus appear. This is one reason vaccination against influenza is given every year.
Events and webinars
- Meeting statementsACM meeting statement, Out of Session Meeting, 10 November 2022Advisory Committee on Medicines meeting statement
- Meeting statementsACM meeting statement, Meeting 38, 30-31 March 2023Advisory Committee on Medicines meeting statement
- Meeting statementsACM meeting statement, Meeting 37, 3 February 2023Advisory Committee on Medicines meeting statement
- Closed onConsultationConsultation: Clarification and updates to the regulation of sunscreensThe TGA is seeking feedback on proposed clarification and updates to the regulation of sunscreens. Closing date: 31 May 2023
- Closed onConsultationPublic consultation on interim decisions to amend the Poisons Standard - ACMS #40 NOVEMBER 2022 (paracetamol)This consultation is for the interim decision in relation to paracetamol which was discussed at the November 2022 meeting of the Advisory Committee on Medicines Scheduling (ACMS).
- Closed onConsultationConsultation: International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient namesThe TGA is seeking views on ingredient names that must be displayed as both the old and new ingredient name on medicine labels.