Medicinal cannabis vaping devices: Information for importers, exporters and manufacturers

Medicinal cannabis vaping devices

This page provides an overview of what businesses involved in the importation, manufacture or supply of medicinal cannabis vaping devices need to know about the regulatory requirements.

The information on this page applies to:

• unfilled devices that are intended to be used to vape medicinal cannabis (e.g. vaporisers)
• parts of devices that are intended to be used to vape medicinal cannabis (e.g. parts of vaporisers such as tanks and mouthpieces; replacement parts and consumables such as seal rings and grinders; and stand-alone items exclusively for use in vaping such as 510 batteries)
• unfilled cartridges, pods, and capsules that are intended to be filled with medicinal cannabis and used with a vaping device.

Items that contain medicinal cannabis, such as filled cartridges, pods and disposable vapes, are not regulated as vaping devices and are regulated in the same way as medicinal cannabis substances.

Important information

Generally, medicinal cannabis vaping devices must be registered on the Australian Register of Therapeutic Goods (ARTG) to be imported, manufactured or supplied in Australia.

The TGA encourages the use of products that have met rigorous safety, quality, efficacy, and/or performance requirements. There are already medicinal cannabis vaping devices included on the ARTG. These products should generally be used where the prescribing health practitioner considers that inhalation is the preferred route of administration for medicinal cannabis.

There are pathways that allow ‘unapproved’ medicinal cannabis vaping devices to be imported into and supplied in Australia for use where registered products are not clinically appropriate. However, sponsors who import unapproved vaping devices should be aware there is no guarantee that an unapproved vaping device will be approved for subsequent supply after it has been imported.

Devices must be only for use with medicinal cannabis

A medicinal cannabis vaping device must be represented (via labelling, product information or other informational material) to be used only to administer medicinal cannabis. A medicinal cannabis vaping device cannot be represented to be used to administer general dry herbs.

Safety and performance requirements for medicinal cannabis vaping devices

Medical devices, including medicinal cannabis vaping devices, must comply with the essential principles.

Further information about complying with the essential principles is available on our website: Essential Principles checklist.

Importing medicinal cannabis vaping devices included in the ARTG

The importation of all medicinal cannabis vaping devices is prohibited unless importers hold an import licence and permit from the Office of Drug Control (ODC).

For a medicinal cannabis vaping device that is not included in the ARTG, an import permit cannot be granted unless the sponsor gives a notice to the TGA stating that the device complies with the essential principles. However, a notice is not required to obtain an import permit for a medicinal cannabis vaping device that is included in the ARTG. This is because the device is taken to comply with the essential principles when included in the ARTG.

Information about how to obtain import licences and permits, including application forms and instructions, is available on the ODC website.

Importing medicinal cannabis vaping devices not included in the ARTG

Importers of medicinal cannabis vaping devices are required to hold an import licence and permit issued by the ODC.

To obtain an import permit for a medicinal cannabis vaping device that is not included in the ARTG, you must first:

• obtain an import licence, and
• provide a notice to the TGA in accordance with the approved form.

The notice requires the importer to state that the goods comply with safety and performance requirements that apply to medical devices under the Therapeutic Goods Act 1989. These are known as the essential principles. The sponsor notice that must be provided to the TGA can be found at: Notice to import cannabis vaping devices.

If the medicinal cannabis vaping device is not intended for supply as a finished product and is instead intended to be used by a licenced manufacturer in the manufacture of a vaping device, a notice to that effect can be provided instead of a notice stating that it complies with the essential principles.

Importers intending to apply for an import licence and permit should be aware that providing information that is false or misleading in an application for an import permit, or a notice stating that goods comply with the essential principles in circumstances where the goods do not comply with the essential principles, is a serious offence subject to criminal penalties under section 137.1 of the Commonwealth Criminal Code.

Further information relating to import licences and permits for medicinal cannabis vaping devices can be found on the ODC website.

See the ODC website for further information relating to the licence and permit requirements for all vaping devices imported into Australia.

Additional importation requirements under the Therapeutic Goods Act

Apart from an import licence and permit being required under customs legislation, the importation of unapproved medicinal cannabis vaping devices must comply with the Therapeutic Goods Act 1989.

Medicinal cannabis vaping devices not included on the ARTG can be imported under the Therapeutic Goods Act 1989 in some circumstances.

An exemption allows sponsors to import unapproved medicinal cannabis vaping devices for the purpose of supply under the SAS and AP pathways. Goods that are imported under this exemption must be stored in a warehouse or properly secured area under the importer’s direct control until the goods are approved for supply to a patient under the SAS or AP schemes.

However, importers should be aware that there are medicinal cannabis vaping devices included on the ARTG. Approvals under the SAS and AP schemes to supply unapproved vaping devices are only given where the ARTG included goods are clinically unsuitable for a patient, and there is no guarantee that goods imported in anticipation of supply under the SAS and AP schemes will be approved.

Importing medicinal cannabis vaping devices with medicinal cannabis

If you are importing both medicinal cannabis and medicinal cannabis vaping devices, you generally will be required to obtain separate import licences and permits under regulations 5 and 5A of the Customs (Prohibited Imports) Regulations 1956.

However, if you are importing a disposable vape or a pre-filled cartridge, pod or capsule that contains medicinal cannabis, you must obtain a permit under regulation 5 of the Customs (Prohibited Imports) Regulations 1956 for the substance and a separate permit under regulation 5A is not required. You also need to generally comply with the regulatory requirements outlined here Medicinal Cannabis: Information for importers, exporters and manufacturers.

Information about how to obtain import licences and permits, including application forms and instructions, is available on the ODC website.

Manufacturing unregistered medicinal cannabis vaping devices in Australia

All medical devices included in the ARTG must comply with the Essential Principles and their manufacturers must apply conformity assessment procedures (or requirements comparable to conformity assessment procedures) that are appropriate to the kind of device (see Manufacturing medical devices: where to start).

Medicinal cannabis vaping devices which are intended to be manufactured in Australia must also be included on the ARTG prior to manufacture, unless an exception to ARTG inclusion applies. In contrast to medicinal cannabis substances, there is no exemption that allows an unregistered medicinal cannabis vaping device to be manufactured in Australia for potential supply under the SAS and AP schemes.

Reporting requirements

Sponsors of therapeutic goods supplied under the SAS and AP schemes must provide six-monthly reports to the TGA.

Regulation 47B of the Therapeutic Goods Regulations 1990 outlines the requirement for sponsors to submit six-monthly supply reports to the TGA listing the product (brand name) details and quantities supplied in Australia during the relevant period.

The TGA uses sponsor six-monthly reporting data to publish details of medicinal cannabis by active ingredient category.

Reporting periods are:

• 1 January - 30 June (inclusive)
• 1 July - 31 December (inclusive).

Reports must be submitted within 1 month of the end of the relevant reporting period.

Please refer to the step-by-step guide for help completing the Sponsor 6 monthly reporting form.

Email your report to medicinal.cannabis@health.gov.au.

Reporting side effects

Sponsors are encouraged to report any side effects (adverse events) from cannabis vaping goods.

The TGA has an important role in monitoring the safety of therapeutic goods, including 'unapproved' goods. Reporting side effects and problems helps us to understand the safety of a product. The TGA investigates significant safety concerns as part of ensuring product safety in the community.

There are multiple ways to report adverse events and defects.

Labelling requirements

Medicinal cannabis vaping devices must meet the relevant Essential Principles for safety and performance to ensure the device is safe and performs as intended.

See: Medical devices labelling and information.

Advertising

Advertising of vaping goods, including all vaping devices, is prohibited unless authorised by the TGA.

See Vapes: advertising and promotion.

Further help

• You should seek the services of a regulatory affairs consultant familiar with current regulatory requirements for importing and supplying vaping goods containing medicinal cannabis or vaping devices for administering those goods.
• Enquiries relating 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 to 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