As the smoking cessation landscape undergoes significant changes, prescribers, pharmacists, and other healthcare providers need clear and concise information to address patient inquiries and ensure compliance. Explore our frequently asked questions to stay informed and confidently navigate the evolving regulatory environment.
Below you will find answers to the following questions:
- How will the new regulations affect my ability to prescribe therapeutic products for smoking cessation?
- What steps do I need to take to ensure compliance with the new pre-market requirements for therapeutic smoking cessation products?
- What do the regulation changes from 1 July 2025 mean for my pharmacy?
- Can I continue to supply smoking cessation products to patients if they were imported before 1 July 2025?
- How will the banning of non-therapeutic product imports impact my practice as a pharmacist?
- How will the new regulations affect my medical practice when patients seek prescriptions to ensure compliance with the updated smoking cessation laws?
- What resources are available to help me stay informed about ongoing regulatory changes in the smoking cessation landscape?
To read the updated regulations in full, click here.
Frequently asked questions about Australia’s smoking cessation regulations
How will the new regulations affect my ability to prescribe therapeutic products for smoking cessation?
Since 1 July 2025, significant changes have been implemented in Australia’s smoking cessation landscape, particularly concerning the prescribing and supply of those products.
It is important that you adhere and comply with the new TGO 110 (2024) and MDSO (2024 amendment) regulations. Although the regulations introduce several technical standards, pharmacies are only responsible for the products you choose to stock and supply.
What steps do I need to take to ensure compliance with the new pre-market requirements for therapeutic smoking cessation products?
To ensure compliance with the new requirements for therapeutic smoking cessation products as of 1 July 2025, here are the key steps you should follow:
- Understand the new regulations:
- Familiarise yourself with the updated Therapeutic Goods Administration (TGA) standards and guidelines.
- The new standards include limits on pharmaceutical-grade ingredients, design and packaging, ingredient restrictions and other requirements.
- Confirm product approval status:
- Verify the therapeutic smoking cessation product is included in the TGA notified vape list located on the TGA’s website under Vaping Hub.
Staying informed about evolving regulations throughout 2025 is crucial for maintaining compliance.
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What do the regulation changes from 1 July 2025 mean for my pharmacy?
Since 1 July 2025, pharmacies can only stock and supply therapeutic smoking cessation products and devices that meet strict new standards under TGO 110 (2024) and MDSO (2024 amendment). These include limits on pharmaceutical-grade ingredients, container sizes, plain packaging and enhanced device safety requirements.
Pharmacies must verify product compliance, follow supply protocols, obtain patient consent, keep records and notify the TGA as required.
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.
Can I continue to supply smoking cessation products to patients if they were imported before 1 July 2025?
Since 1 July 2025, all therapeutic smoking cessation products must adhere to the new standards. Any product imported before this date that does not meet these standards can no longer be prescribed or supplied.
How will the banning of non-therapeutic product imports from 1 March 2024 impact my practice as a pharmacist?
Pharmacies are the only place consumers can access regulated smoking cessation products, some of which require a prescription. Pharmacists should review their inventory and ensure patients are aware of any changes to supply or access.
How will the new regulations affect my medical practice when patients seek prescriptions to ensure compliance with the updated smoking cessation laws?
For starters, prescribers can only prescribe smoking cessation products that meet the new Therapeutic Goods Administration (TGA) standards. Products that don’t comply, even if previously supplied or imported can no longer be prescribed or dispensed.
There may be an increase in patients seeking prescriptions for therapeutic smoking cessation products. With the removal of administrative barriers and a greater emphasis on access to smoking cessation and nicotine dependence aids, patients may be more likely to seek assistance from healthcare professionals.
What resources are available to help me stay informed about ongoing regulatory changes in the smoking cessation landscape?
You can stay informed about ongoing regulatory changes in the smoking cessation landscape by accessing reliable resources such as the Therapeutic Goods Administration (TGA). Additionally, the Canview Education Hub has a wide variety of resources available in the Key Opinion Leader webinars.