The Impact of the Upcoming Changes to Smoking Cessation Product Legislation on Australian Pharmacists
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Effective 1 July 2025, Australian pharmacies will face significant changes to the way they stock and supply smoking cessation products, particularly nicotine vaping products (NVPs). These changes, part of a broader effort to strengthen public health and product safety, will require pharmacists to align with new regulatory standards aimed at improving both product quality and patient outcomes. Let's dive into these important changes and their impact on Australian pharmacists.
What Are the Key Legislative Changes?
The Australian Government has been progressively updating regulations for therapeutic nicotine vaping products (NVPs) to ensure that vaping is used safely and effectively as a smoking cessation tool. The changes have been rolled out in phases, with the final stage set to begin on 1 July 2025. From this date onwards, all vaping products sold by Australian pharmacies must comply with two crucial sets of standards:
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TGO 110 (2024) – Vaping Substances.
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MDSO (2024) – Devices and Accessories.
These standards will govern everything from nicotine content to packaging design, and are set to reshape the market for nicotine vaping products.
Summary of Previous Changes
To understand the significance of the July 2025 reforms, let’s quickly review the previous phases of change:
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October 2024:
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Personal Importation of NVPs Prohibited: Australians can no longer import their own nicotine vaping products. All therapeutic NVPs must be obtained from Australian pharmacies with a valid prescription.
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March 2025:
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Additional Restrictions: New restrictions on flavors and packaging come into effect, alongside updated transitional standards for vaping devices.
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Closed-System Vaping Products Only: Pharmacies will be allowed to stock only closed-system products, which are generally considered safer and more standardized than open-system devices.
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Key Changes Effective 1 July 2025
The final phase of the regulatory changes will impose more stringent rules for both the substances and devices sold in pharmacies:
TGO 110 (2024) – Vaping Substances
From 1 July 2025, any therapeutic NVPs stocked by pharmacies must adhere to the following standards:
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Nicotine Limit: The nicotine content of vaping substances will be capped at 50 mg/mL (base form or equivalent).
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Menthol Limit: A maximum of 20 mg/mL for menthol flavors.
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Container Size:
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Maximum size for bottles is 60 mL.
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Pod capacity is restricted to 5 mL.
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Ingredient Restrictions: Only specific pharmaceutical-grade ingredients will be allowed.
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Plain Packaging: Products must have a standardized design, include a patient information leaflet, and comply with restrictions on product naming and marketing.
These changes aim to improve consistency, safety, and clarity for patients, ensuring that therapeutic vaping products are used appropriately and in a controlled manner.
MDSO (2024) – Devices and Accessories
Changes to the MDSO (2024) will affect all vaping devices and accessories, including:
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Plain Design & Packaging: Devices and accessories must feature simple, non-branded packaging with clear, user-friendly instructions.
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Enhanced Technical Compliance: Devices must meet medical device quality standards, including:
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Risk management protocols.
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Electrical and battery safety standards.
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Specific design and construction criteria.
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Toxicological Risk Assessments: Vaping devices will undergo detailed assessments to ensure the safety of materials and components used in their construction.
Most devices currently available will no longer meet these stricter standards, meaning pharmacies will need to update their inventory.
Transition Period: March to June 2025
Between March and June 2025, pharmacies will have a transition period during which they can continue supplying products that comply with either the 2024 or the 2025 standards. This gives manufacturers time to adapt their products and ensure that the updated formulations and devices are ready for sale.
However, after 1 July 2025, only fully compliant products will be allowed to be stocked and sold in pharmacies.
What Does This Mean for Pharmacists?
The impending changes will undoubtedly have a significant impact on Australian pharmacies, particularly in terms of compliance and supply management. Here’s what pharmacists need to keep in mind:
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Product Compliance:
Pharmacists will need to ensure that all nicotine vaping products they stock meet the updated standards outlined in TGO 110 (2024) and MDSO (2024). This includes checking the nicotine content, packaging, and ingredients of substances, as well as the technical specifications of devices. -
Supply Protocols:
Therapeutic NVPs must be stored behind the counter and only supplied to patients when clinically appropriate. Pharmacies will also need to confirm that patients provide valid identification and informed consent before dispensing NVPs. -
Record Keeping:
When dispensing Schedule 3 NVPs, pharmacies must maintain detailed records and submit notifications to the Therapeutic Goods Administration (TGA) through the Special Access Scheme – Category C (SAS-C). -
Guiding Patients:
Pharmacists will play a crucial role in educating patients about the new standards, ensuring they understand the changes to product formulations, packaging, and safety information.
How Can Pharmacists Navigate These Changes?
With the deadline of 1 July 2025 rapidly approaching, it’s essential for pharmacies to prepare in advance. Fortunately, there are a number of resources and partnerships available to assist with this transition:
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Canview’s Support: As a trusted partner, Canview is working closely with suppliers to ensure compliance and maintain uninterrupted supply for our pharmacy partners. We are dedicated to offering only products that meet TGO 110 (2024) and MDSO (2024).
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Regular Updates: Stay informed with ongoing updates, guidance, and resources to ensure your pharmacy is fully prepared for the upcoming changes.
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Compliance Assurance: Our platform ensures that all listed products are fully compliant with the new regulations, allowing pharmacies to rest easy knowing their stock meets the latest standards.
The Role of Pharmacists in Supporting Patient Health
The updated legislation is ultimately designed to provide patients with safer, more effective smoking cessation options. Pharmacists have a vital role in ensuring that patients are provided with the right information and guidance to make informed decisions about their smoking cessation journey.
By offering clear, supportive advice and ensuring that only compliant, high-quality products are available, pharmacists can build trust with their patients and contribute to a healthier Australia.
Resources for Pharmacists:
Conclusion
As the Australian Government continues to refine its approach to nicotine vaping products, the upcoming changes to legislation are set to have a major impact on pharmacies. While the new rules may pose challenges, they also present an opportunity for pharmacists to improve the safety, efficacy, and quality of smoking cessation products. By staying informed and prepared, pharmacists can continue to provide valuable support to patients while navigating the evolving regulatory landscape.
References:
https://www.tga.gov.au/news/media-releases/enhanced-product-standards-therapeutic-vapes-2025