SYDNEY VAPORIZERS NO LONGER IMPORTS OR SELLS THIS VAPORIZER

If this vaporizer has been legally imported into Australia through a licensed business; using permits issued by the ODC, then this vaporizer is an: 'Unapproved Therapeutic Vaping Device'

Unapproved Therapeutic Cannabis Vaping Devices

The Therapeutic Goods Administration (TGA) has established a regulatory pathway that permits an Australian-licensed entity to import certain cannabis vaporizers into Australia.

Under this pathway, the licensed importer must execute a declaration confirming that the device complies with the Australian Essential Principles Guidelines (AEPG) applicable to medical devices and submit this declaration to the TGA. Where the TGA is satisfied that the declaration demonstrates compliance, it will issue an item number specific to that vaporizer. The importer must then apply to the Office of Drug Control (ODC) for an import permit, referencing the issued item number. Upon approval, the ODC will grant a permit authorising the importation of the device, which is valid for a period of 12 months.

Approximately one third of the AEPG requirements relate to product labelling and instructions for use. Accordingly, the vaporizer and its accompanying user manual must clearly and unequivocally state that the device is for use only with medicinal cannabis flower. Vaporizers described or labelled as “dry herb vaporizers,” or as being intended for aromatherapy or non-medicinal purposes, do not meet the AEPG requirements and are therefore unlawful to import, distribute, or supply in a retail or pharmacy setting within Australia. Only devices expressly intended for use with medicinal cannabis flower are capable of complying with the Australian Essential Principles.

Once imported into Australia by a licensed entity pursuant to an ODC permit, vaporizers that are not included on the Australian Register of Therapeutic Goods (ARTG) are classified as Unapproved Therapeutic Vaping Devices (UTVDs). The sole lawful mechanism by which a UTVD may be supplied to a patient in Australia is pursuant to a Special Access Scheme Category B (SAS-B) approval issued by the TGA.

All UTVDs that have been lawfully imported must remain secured within the licensed importer’s approved warehouse until a valid SAS-B approval has been granted for the specific device. Licensed importers are required to submit six-monthly reports to the ODC detailing the location of all UTVD stock. Where a device is not held within the importer’s secure warehouse, the importer must hold a corresponding SAS-B approval authorising the supply of that device.

Any licensed importer who knowingly contravenes these regulatory requirements may be subject to severe criminal penalties, including fines of up to AUD $1,000,000 and/or imprisonment for a term of up to seven years.

SAS-B Approvals for Unapproved Therapeutic Vaping Devices

To obtain a SAS-B approval for an Unapproved Therapeutic Vaping Device, a patient must request that an Authorised Prescriber submit an application to the TGA for that specific device and for that individual patient. The SAS-B application must include a clear clinical justification demonstrating why the patient is unable to use a vaporizer that is currently registered on the ARTG, such as the Mighty+ MEDIC or the Volcano MEDIC 2.

The TGA has expressly stated that SAS-B approvals will only be granted where there is sufficient clinical evidence supporting the patient’s inability to use an ARTG-registered device. The TGA has also reiterated to importers that all UTVDs, once legally imported, must remain within the licensed importer’s secure warehouse unless and until a SAS-B approval has been issued permitting their supply.

Sleek and stylish, the PAX Mini vaporizer features advanced convection heating that evenly heats your dry herbs for a rich vapor and more consistent flavor.

The Mini is a no-brainer choice for those who want to avoid fancy settings and prioritize flavor. The device features only one setting, LED feedback, and heats up in just 22 seconds, making it ideal for short sessions.

Available in two matte colors, Onyx and Platinum, the device is ultra-portable and perfect for vaping beginners who want to enjoy flower sessions on the go without drawing unwanted attention.

The PAX Mini features a convection heating system and a new oven design, optimized for evenly heating your materials and delivering rich vapor from the first hit to the last.

The 3D oven screen makes it easy to access every corner and allows for deep cleaning. With the included wire brush, cleaning becomes more accessible and quicker.

The oven fits 0.25g, which makes it perfect for solo sessions

Featuring a minimalistic, classy, and durable design, the PAX Mini is equipped with only one setting/button and is super easy to use, even for a complete beginner.

To operate, remove the magnetic oven lid, check that the 3D filter is in place, and pack your dry herbs. Then attach the mouthpiece of your choice and press the power button to get the party started. A LED light will indicate once the device is heated.

The PAX Mini heats up in just over 20 seconds and automatically adjusts the temperature for you.

The device features a patented temperature control that heat and never burns, preserving natural terpenes and bringing the best out of your material without harsh smoke.

When designing the Mini, PAX put flavor first, letting you take your sesh to the next level!

Not only is the PAX Mini pocket-sized, but it also offers significant battery autonomy and easy charging.

Its built-in, long-lasting battery lasts over two hours on a single charge, which makes it ideal for hits on the go. Once empty, users can quickly recharge it via a magnetic USB charging dock.

On top, the magnetic oven lid helps keep your stash secure and your pockets always clean.

BOX INCLUSIONS:

• 1x PAX Mini Vaporizer
• 1x Flat & Raised Mouthpieces
• 1x Maintenance Kit
• 1x USB Charging Cable