Question to ask

Why is this important?

How Liber addresses the question

Has the manufacturer sought/secured distribution from a national wholesaler?

Distribution is critical to ensure that your patients have ready access to the NVP that you prescribe. 

If the manufacturer has sought such arrangements, why have they not succeeded?

Liber has distribution arrangements with Symbion, API and Sigma.

Nicovape® Q is the only NVP distributed at a banner group level by Chemist Warehouse, Terry White Chemmart, Priceline and a number of other banner groups.

In which other markets does the manufacturer sell its products as non-medicines/consumer goods?

NVPs sold outside of Australia are sold as consumer products, and will have been marketed as such.

Understanding the overseas strategy of products that you are being asked to prescribe as medicines allows you to consider the reputational risk associated with prescribing them.

Liber has never sold its Nicovape® Q products as consumer products or in markets outside of Australia.

Liber complies with all Commonwealth and State legislation pertaining to the manufacture, importation, distribution and sale of NVPs.

Is the manufacturer an Australian sponsor?

If the sponsor is Australian, they are subject to the TGA’s regulations.

Certain manufacturers appear Australian, but are actually an offshore entity outside of the scope of Australian enforcement.

Liber is Australian incorporated and is the sponsor of Nicovape® Q.

Does the manufacturer have a consumer e-commerce store or social media presence?

While many brands claim to be legitimate medical products, does their online history support that or are they simply pivoting from being a recreational product to drive sales?

Consider how that may reflect on you if you prescribe the brand in question.

Liber and the Nicovape® Q have online presences appropriate for the pharmaceutical channel and adhere to the TGA’s advertising restrictions on NVPs as unlicensed Schedule 4 medicines.

Does the manufacturer have a commercial relationship with any prescribing doctors?

If the brand that you are prescribing has commercial relationships with other prescribing doctors to prescribe their products, are these properly disclosed to prevent conflicts?

Liber has no contractual relationship with any telehealth platform or prescribing doctors for Nicovape® Q.

Does the manufacturer have a declaration of conformity with TGO 110, product liability insurance, adverse event reporting, and product recall infrastructure?

While other brands may meet TGO 110 requirements, the standard doesn’t cover all factors for pharmacy distribution suitability. Overseas brands aren’t subject to compliance audits.

Addressing insurance and domestic infrastructure questions helps assess appropriateness.

Liber has all of the aforementioned in relation to its Nicovape® Q product offering.

Indeed, without these, it would not consider itself appropriate to be distributed as a medicine through the pharmacy channel.

What are the manufacturer’s plans for medical licencing, if any? Do they view TGO 110 as the end-point, or an interim step towards ARTG registration?

The TGA and other regulators like the UK’s MHRA have encouraged NVP manufacturers to seek medical registration since 2017. Medical licensing aligns with the public health goal of reducing nicotine & smoking addiction. 

ARTG registration transfers prescribing / dispensing risks from doctors and pharmacists to the TGA.

Liber designed its product to meet the requirements of medical registration, and first met the TGA in 2020 about licensing the Nicovape® Q, and the MHRA earlier this year.

Liber remains committed to seeking medical registration in both markets and continues to work with regulators to agree the requirements to file licensing applications.

Does the manufacturer make claims or recommend treatment regimes, such as nicotine “step down” protocols, that are not supported by scientific evidence?

It is critical that doctors can trust manufacturers to give science-based advice and, where there are unanswered questions, to trust doctors to make the right decisions for their patients.

Liber provides doctors with the most up-to-date scientific information and trusts doctors to develop the best practices for NVP-based smoking cessation therapy.