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Therapeutic vapes

Guidance

Final guidance on nicotine vaping products and vaping devices - Therapeutic Goods Order 110 (TGO 110) Order and related matters.

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The purpose of this guidance is to help health practitioners, consumers, importers and other sponsors, wholesalers and manufacturers to understand the minimum safety and quality requirements that apply to unregistered products under the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021. It also explains our role in regulating vaping devices.

  • Glossary
  • About this guidance
    • What this guidance does not cover
    • Advertising and promotion of therapeutic vapes
  • Product standard TGO 110
    • Commencement
    • Objectives
    • Application
    • Overview
      • Summary of TGO 110 requirements
  • Record-keeping obligations for sponsors
    • Who is an Australian sponsor?
    • Types of records that must be kept
    • Updates and record retention
  • Labelling of therapeutic vapes
    • Ingredient list
    • Nicotine concentration
    • Warnings statements
  • Product packaging and closures
    • Child-resistant packaging (CRP)
      • Child-resistant packaging requirements in TGO 95
    • Non-mandatory container requirements
      • Tamper-evident packaging
    • Container volumes
  • Ingredients in therapeutic vaping substances
    • Active ingredients
      • Nicotine is the only permitted active ingredient
      • Actual vs labelled nicotine concentration and content
      • Limits on nicotine concentration
    • Excipient ingredients and flavours
      • Prohibited ingredients
      • Permitted flavours in therapeutic vaping substances
  • Contaminants and product quality
    • Default standards
    • Microbiological standards
    • Contaminants
  • Report side effects and problems
  • Therapeutic vaping devices and therapeutic vaping device accessories
    • Changes to requirements
    • Essential Principles
    • MDSO (Medical Devices Standard Order)
      • Quality management certification
      • Comparable regulatory approval
      • Consumer e-cigarette authorisation or notification
    • Regulation of vaping devices and vaping device accessories
      • Disposable vapes
      • Refillable, reusable vaping devices and vaping device accessories
  • Appendix A: References

Supporting documents

Topics

This webpage on the TGA website was printed on 12 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/therapeutic-vapes

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