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Important information
Import requirements for devices that are used to vape cannabis are changing.
The changes relate to:
- reusable vaporisers
- parts of reusable vaporisers
- stand-alone items for use in vaping such as 510 batteries for use with medicinal cannabis cartridges
- empty vape cartridges that are designed to be filled with medicinal cannabis.
From 1 March 2024, importers of these goods MUST HAVE an import licence and permit.
If these vaping devices are not included in the Australian Register of Therapeutic Goods, you will need to give the TGA a completed Notice to import cannabis vaping devices.
A notice must be given so you can be eligible for an import permit.
Further information relating to import licences and permits can be found here.
If the vaping device you import is not represented (via labelling, Product Information or other informational material) to be used only to contain or administer medicinal cannabis, it is not eligible for a permit for a cannabis vaping device.
From 1 March 2024, the only other vaping devices that can lawfully be imported are those that are to be used only to contain or administer substances that are only for smoking cessation or the management of nicotine dependence. See here for further information relating to the licence and permit requirements for all vaping devices.
Introduction
A reference in this guidance to medicinal cannabis is a reference to both medicinal cannabis products and medicines containing synthetic cannabis.
The importation of medicinal cannabis is subject to strict regulation. Importers of these goods must hold an import licence and permit in relation to the goods from the Office of Drug Control (ODC).
Under the Therapeutic Goods Act 1989, all therapeutic goods, including medicinal cannabis and devices used to vape medicinal cannabis, must either be included in the Australian Register of Therapeutic Goods or otherwise be exempt, approved or authorised, principally under the special access scheme (SAS) or the authorised prescriber (AP) scheme, before they are imported, manufactured or supplied.
New amendments to the Customs (Prohibited Imports) Regulations 1956 and Therapeutic Goods (Medical Devices) Regulations 2002 commenced on 1 January 2024 and apply to vaping goods imported from 1 March 2024. These amendments will affect importers of reusable cannabis vaping devices, parts of reusable cannabis vaping devices, and refillable cannabis vaping device accessories, that do not contain medicinal cannabis but are intended to be used with medicinal cannabis.
A reference in this guidance to an importer is a reference to any person seeking to import medicinal cannabis, cannabis vaping devices or cannabis vaping device accessories. This includes health professionals importing such goods under the SAS and AP pathways and sponsors who use the ‘direct control exemption’ provided in the regulations made under the Therapeutic Goods Act 1989 (the Act).
Cannabis vaping devices and cannabis vaping device accessories
The new reforms apply to reusable vaping devices intended only to administer medicinal cannabis (a cannabis vaping device) and unfilled and refillable cartridges, pods etc that are intended only to be filled with medicinal cannabis and to be used with a cannabis vaping device (a cannabis vaping device accessory).
A cannabis vaping device can include a vaporiser, as well as parts of a vaporiser such as a tank or mouthpiece. It can also include stand-alone items that are designed to be assembled with other stand-alone items, such as a 510 battery that is designed to be attached to a cartridge containing medicinal cannabis and allows for the administration of that medicine.
From 1 March 2024, there will be a ban on the importation of all vapes unless importers hold an import licence and permit from the ODCODCODC. In relation to importers of cannabis vaping devices and cannabis vaping device accessories, only those importers who import goods that are intended to be used exclusively with medicinal cannabis will be eligible for an import licence and permit i.e. devices and device accessories that are therapeutic goods. The importation of cannabis vaping devices and cannabis vaping device accessories that are intended for multiple purposes, including recreational purposes, will be prohibited.
From 1 March 2024 the only vapes that can lawfully be imported will need to either be exclusively for the administration of medicinal cannabis OR the administration of substances that are for smoking cessation or the management of nicotine dependence. The importation of multipurpose vapes and recreational vapes will be prohibited.
Importing vaping goods that are or contain medicinal cannabis
All existing importation requirements continue to apply to medicinal cannabis. Find further information relating to the importation of medicinal cannabis here.
This means, despite the reforms, an importer of any vaping substance (i.e. cannabis oil), disposable cannabis vape or cannabis vaping accessory (a filled pod, cartridge etc used with a cannabis vaping device) that is, or contains, medicinal cannabis, need only hold an import licence and permit in line with the existing requirements.
The new reforms, however, will impact importers who intend to import reusable cannabis vaping devices that contain, or are supplied with medicinal cannabis from 1 March 2024. New requirements will apply irrespective of how the medicinal cannabis is supplied i.e. whether the medicinal cannabis is contained in a tank of a reusable cannabis vaping device, a cartridge or a dripper bottle. Importers who intend to import a cannabis vaping device accessory that will be supplied with medicinal cannabis will be similarly affected. Please see below for further information.
Importing reusable cannabis vaping devices included in the Register
From 1 March 2024, importers of cannabis vaping devices and cannabis vaping device accessories included in the Register will be required to hold an import licence and permit in relation to the goods from the ODC.
Information about how to obtain import licences and permits, including application forms and instructions, is available on the ODC website here.
Importing reusable cannabis vaping devices not included in the Register
From 1 March 2024, importers of cannabis vaping devices and cannabis vaping device accessories that are not included in the Register will be required to hold an import licence and permit in relation to the goods, issued by the ODC.
To be eligible to obtain an import permit for a cannabis vaping device that is not included in the Register, an importer must provide a pre-market notification to the TGA, prior to the importation of the goods, stating that the goods comply with the essential principles or are to be imported with the consent of the Secretary under section 41MA or 41MAA of the Therapeutic Goods Act 1989.
Importers should be aware that consent is only granted in exceptional circumstances and for a limited period.
The notice that must be given to the TGA, can be found here – Notice to import cannabis vaping devices.
Information about how to obtain import licences and permits, including application forms and instructions, is available on the ODC website here.
Importing reusable cannabis vaping devices together with medicinal cannabis
All existing importation requirements continue to apply to medicinal cannabis. Find further information relating to the importation of medicinal cannabis here.
From 1 March 2024, importers who intend to import a reusable cannabis vaping device that contains, or will be supplied with, medicinal cannabis OR a cannabis vaping device accessory that will be supplied with medicinal cannabis, will need an import licence and permit relating to the medicinal cannabis AND a separate import licence and permit relating to the cannabis vaping device or cannabis vaping device accessory. If the device or device accessory is not included in the Register, the importer will need to provide a pre-market notice to the TGA declaring their device or device accessory complies with the essential principles, prior to the importation of their goods.
The notice, that must be given to the TGA, can be found here – Notice to import cannabis vaping devices
The notice is a precondition for applying to the ODC for an import permit in relation to the vaping goods.
Information about how to obtain import licences and permits, including application forms and instructions, is available on the ODC website here.
Further help
- You should seek the services of a regulatory affairs consultant familiar with relevant regulatory requirements for specific advice and assistance in relation to product development and regulatory requirements.
- Enquiries related to cultivation, production, the manufacture of medicines or the import or export of medicines, should be directed to the Office of Drug Control.
- SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), start-ups and researchers who are developing new medicines and medical devices understand their regulatory and legislative obligations.
Additional information and resources
- Medicinal cannabis reforms: Frequently asked questions
- Reminder: supply and advertising controls on medicinal cannabis
- Supply and wholesaling of medicinal cannabis products (MCP)
- Conforming with TGO93
- Access to medicinal cannabis: Frequently asked questions
- Medicinal cannabis reforms: Frequently asked questions
- Regulation basics
- Office of Drug Control