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 October 2024 mean for my pharmacy?
- Can I continue to supply disposable smoking cessation products to patients if they were imported before 1 January 2024?
- How will the banning of non-therapeutic product imports from 1 March 2024 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?
The new regulations streamline the process for prescribing therapeutic products, eliminating the need for TGA approval.
As of 1 January 2024, GPs and nurse practitioners can now prescribe therapeutic products for smoking cessation without navigating bureaucratic hurdles.
What steps do I need to take to ensure compliance with the new pre-market requirements for therapeutic smoking cessation products?
Manufacturers of therapeutic smoking cessation products must obtain customs licenses and permits for importing them. Additionally, adherence to product standards, including flavour limitations and device specifications, is essential.
Staying informed about evolving regulations throughout 2024 is crucial for maintaining compliance.
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What do the regulation changes from 1 October 2024 mean for my pharmacy?
Starting 1 October 2024, smoking cessation products that have a concentration of 20mg/ml or less will be available from all Australian pharmacies to patients 18 years and over without a prescription where a pharmacist has assessed this to be clinically appropriate. Smoking cessation products will only be available to patients under 18 years with a prescription, if clinically appropriate, subject to any state and territory laws.
These changes will greatly impact the role of pharmacists, reinforcing their role as essential healthcare providers in smoking cessation initiatives. Moreover, they will take on additional duties, such as verifying product compliance, overseeing inventory and guiding patients on correct dosage and use.
Can I continue to supply disposable smoking cessation products to patients if they were imported before 1 January 2024
Yes, therapeutic smoking cessation products imported before 1 January 2024 can still be lawfully supplied to patients, provided they meet specific criteria outlined in the regulations. However, healthcare professionals should verify that these products comply with applicable standards and requirements.
How will the banning of non-therapeutic product imports from 1 March 2024 impact my practice as a pharmacist?
As smoking cessation products will only be available via a prescription, pharmacies will become the sole source of supply for these products for consumers. Pharmacists should adjust their inventory accordingly and communicate any changes to patients.
How will the new regulations affect my medical practice when patients seek prescriptions to ensure compliance with the updated smoking cessation laws?
Prescribers may anticipate a significant 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 aids, patients may be more likely to seek assistance from healthcare professionals for smoking cessation.
Prescribers can expect to play a more active role in prescribing these treatments as part of comprehensive smoking cessation strategies.
What resources are available to help me stay informed about ongoing regulatory changes in the smoking cessation landscape?
With product standards continuing to be strengthened into the latter part of 2024, healthcare professionals can stay informed about ongoing regulatory changes in the smoking cessation landscape by accessing resources provided by relevant regulatory bodies, 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.