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' (UTVD)

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.

For those with a discerning taste in devices, PAX Plus is a two-in-one device that lets you dabble in the dry herb and concentrates without any harsh smoke. With four experience modes, a swift heat-up time, and a run time of 2.5 hours, you can enjoy 8-10 smooth sessions without running out of juice.

Packed with a host of accessories like a concentrate insert, magnetic oven lid, two types of mouthpieces, and multipurpose dab tool, this pocket-sized device is discreet and efficient.

The PAX Plus is flexible and customizable, with four experience modes that cater to your mood. You can control your sessions by pushing a button, switching between Stealth, Efficiency, Flavor, and Boost. Each mode heats gently, so you never have to worry about harsh smoke. Say goodbye to the over-scorched herb or concentrates and hello to flavorful hits and dense clouds.

You’ll instantly switch from dry herbs to concentrates with the included concentrate insert. Thanks to the included oven lids, you can tweak the size of your bowl and reduce your dose if you’re looking for a shorter session.

The PAX Plus vaporizer kit comes with a slew of accessories plus a reliable 3300mAh battery with a run time of 2.5 hours. The kit comes with new and improved 3D oven screens and two kinds of mouthpieces. It includes a redesigned multi-tool and a brush that makes oven cleaning quick, simple, and hassle-free.

BOX INCLUSIONS:

• 1x PAX Plus Vaporizer
• 1x Flat Mouthpiece
• 1x Raised Mouthpiece
• 1x Oven Lid
• 1x Half-Pack Oven Lid
• 1x Concentrate Insert
• 3x 3D Oven Screens
• 1x Multi-Tool
• 1x Wire Brush
• 1x USB Charger