Updated June 2025
Understanding smoking cessation product legislation changes
Quick summary
From 1 July 2025, pharmacies can only stock and supply therapeutic smoking cessation products that meet updated standards as outlined in TGO 110 (2024) and MDSO (2024). These final-phase changes complete the Australian government’s regulatory reforms aimed at improving product safety and consistency.
Key changes from 1 July 2025:
- Stricter limits on ingredients and packaging
- Max therapeutic ingredient: 50mg/mL; menthol: 20mg/mL
- Max container sizes: 60mL (bottles); 5mL (pods)
- Plain packaging, restricted naming and mandatory patient info leaflets
- New compliance standards for all devices and accessories
- Devices must meet quality management, safety and design standards
- Plain packaging and clear instructions now mandatory
- Only compliant products can be stocked or sold
- Non-compliant products must be removed from pharmacy shelves by 1 July 2025
Canview is working with suppliers to ensure all listed products meet these new requirements, giving pharmacies confidence and continuity.
Summary of past changes
October 2024: Initial changes
- Personal importation of smoking cessation products prohibited
- All therapeutic smoking cessation products can only be accessed from an Australian pharmacy with a prescription
March 2025: Further product restrictions
- Additional restrictions on flavors and packaging
- Updated transitional standards for devices
- Only closed-system products permitted
- Suppliers and pharmacists allowed to transition toward updated 2025 standards
Overview of the TGA’s enhanced product standards
The Therapeutic Goods Administration (TGA) introduced strengthened product standards for unapproved therapeutic smoking cessation products in 2024. These standards apply to:
- Therapeutic substances, including prefilled pods and e-Liquids, under Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Instrument 2024, also referred to as TGO 110 (2024)
- Therapeutic devices and accessories, such as refillable pods, under Therapeutic Goods (Medical Device Standard – Therapeutic Vaping Devices) Order (MDSO) 2024, also referred to as MDSO (2024)
The changes have been rolled out in phases, with the final phase affecting pharmacies from 1 July 2025. From this date, only products that comply with TGO 110 (2024) and MDSO (2024) may be lawfully supplied by pharmacies.
Key legislation changes from 1 July 2025
TGO 110 (2024) – Vaping substances
From 1 July 2025, all therapeutic smoking cessation products sold by pharmacies must comply with the following:
- Nicotine limit: Maximum 50 mg/mL (base form or equivalent)
- Menthol limit: Maximum 20 mg/mL
- Container size: Maximum of 60 mL for bottles and 5 mL for pod capacity
- Ingredient restrictions: Only specific pharmaceutical-grade ingredients permitted
- Plain packaging requirements: Standardised pack design, inclusion of a patient information leaflet and restrictions on product naming
These requirements aim to improve consistency, safety and clarity for patients using NVPs to support smoking cessation.
MDSO (2024) – Devices and Accessories
The updated MDSO (2024) introduces stringent requirements for all therapeutic devices and accessories, including:
- Design and packaging: Devices and accessories must feature a plain design with plain packaging and user-friendly instructions for use
- Technical compliance: Devices must meet enhanced standards including:
- Medical device quality management systems
- Risk management protocols
- Electrical and battery safety standards
- Specific design and construction criteria
- Toxicological risk assessment: Required to ensure safety of materials and components
This regulatory shift means most devices currently in use will no longer be compliant from 1 July 2025.
Transition period: March to June 2025
Until 1 July 2025, pharmacies may continue supplying products that meet either the 2024 or 2025 standards. This transition window allows time for manufacturers to adjust product formulations and devices, and for pharmacies to prepare their stock. However, from 1 July 2025, only fully compliant products may be stocked or sold.
What this means for pharmacies
These changes have introduced some uncertainty, particularly around device compliance. But pharmacies don’t have to navigate this shift alone.
At Canview, we remain in close communication with all suppliers to ensure compliance and uninterrupted supply for our pharmacy partners. We are actively working to support pharmacists by:
- Ensuring our platform only offers products that meet TGO 110 (2024) and MDSO (2024)
- Working with suppliers to finalise compliant inventory ahead of July deadlines
- Keeping our partners informed with updated guidance and resources
Ongoing responsibilities for pharmacists
Although the regulations introduce several technical standards, pharmacies are only responsible for the products they choose to stock and supply. Key areas of focus include:
- Product verification: Ensuring smoking cessation substances and devices are compliant with TGO 110 (2024) and MDSO (2024)
- Supply protocols: Therapeutic products must be stored behind the counter and supplied only when clinically appropriate
- Patient interaction: Patients must provide valid identification and informed consent, and pharmacists should offer usage guidance
- Notification and record keeping: When supplying Schedule 3 products, pharmacists must submit notifications to the TGA via the Special Access Scheme – Category C (SAS-C) and maintain appropriate supply records
Supporting patients through change
These strengthened standards aim to ensure safer, more effective options for patients using these products as a smoking cessation tool. Pharmacists play an important role in supporting this outcome by:
- Guiding patients to appropriate and compliant options
- Ensuring product safety and supply compliance
- Building trust through clear, supportive advice
With a trusted trade partner like Canview, pharmacies can feel confident knowing they have access to compliant, ready-to-supply products as the market evolves.
Helpful resources
Understanding product standards for unapproved therapeutic vapes in Australia (TGA overview)
TGO 110 (2024) summary – Vaping substances
MDSO (2024) summary – Vaping devices and accessories
Source
Therapeutic Goods Administration (TGA). “Enhanced product standards for therapeutic vapes in 2025.” https://www.tga.gov.au/news/media-releases/enhanced-product-standards-therapeutic-vapes-2025. (retrieved on 6 December 2024)