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.
- Check if your health product is a non-prescription medicinePageMake sure your supplement, vitamin or complementary medicine is regulated as a non-prescription medicine
- Types of non-prescription medicines and application processPageOverview of the application processes for the different types of non-prescription medicines.
- Non-prescription medicine requirements and standardsPageFind out what standards and requirements you must comply with to legally sell or supply your medicine in Australia.
- Apply to sell or supply a non-prescription medicinePageHow to get your non-prescription medicine onto the Australian Register of Therapeutic Goods for sale or supply in Australia
- TGA evaluation of non-prescription medicinesPageLearn about conditions of listing, post-market reviews and registered medicine evaluation.
- Managing your non-prescription medicine and TGA accountPageLearn about your on-going responsibilities once your non-prescription medicine is on the Australian Register of Therapeutic Goods.
- Reforms to the regulation of non-prescription medicinesPageReforms for non-prescription medicines.
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
Resources
- Serious Scarcity Substitution Instruments (SSSIs)GuidanceSerious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
- Seasonal influenza vaccines - quality moduleGuidanceExplanatory guide on the quality modules to be submitted for influenza vaccine registration, for manufacturers and sponsors.
- Pre-clearance application for animal-derived ingredientsFormsThis form is to assist users of the Electronic Lodgement Facility (ELF) seeking preclearance for animal derived ingredients by detailing what the TGA is looking for and what supporting documents need to be provided.
Latest alerts
- GlucaGen HypoKit shortage extended by one monthMedicine shortage alertsGlucaGen HypoKit (glucagon) shortage will be extended by one month to 31 October 2023
- Product Defect Correction: Permobil Push-tracker/Smart DriveProduct recallsFind out about a software problem with the SmartDrive MX2+ App, for the PushTracker E2 and E3 wearable watches, causing safety issues for operating manual wheelchairs.
- Substitution approved for vigabatrin (Sabril) shortageMedicine shortage alertsTo help manage the shortage of the tablet form of vigabatrin (Sabril), we have made a Serious Scarcity Substitution Instrument that allows a pharmacist to provide the oral sachets.
Latest articles
- COVID-19 vaccine safety report - 21-09-2023COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- Product Information safety updates - September 2023Safety updatesMedicines Safety Update - Information for health professionals
- COVID-19 vaccine safety report - 07-09-2023COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
Latest publications
- ACM meeting statement, Meeting 39, 1-2 June 2023Meeting statementsAdvisory Committee on Medicines meeting statement
- ACM meeting statement, Meeting 37, 3 February 2023Meeting statementsAdvisory Committee on Medicines meeting statement
- ACM meeting statement, Meeting 38, 30-31 March 2023Meeting statementsAdvisory Committee on Medicines meeting statement
Latest consultations
- Consultation: 2023-2024 Proposed changes to the Permissible Ingredients Determination – Low-negligible riskClosed onConsultationThe TGA is conducting a public consultation and seeking feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
- Consultation: Guidelines for the Quality of Listed Probiotic MedicinesClosed onConsultationWe are seeking feedback on the proposed new ‘Guidelines for the Quality of Listed Probiotic Medicines’.
- Consultation: Clarification and updates to the regulation of sunscreensClosed onConsultationThe TGA is seeking feedback on proposed clarification and updates to the regulation of sunscreens. Closing date: 31 May 2023