Guidance: Applying for permission to import medicinal cannabis and cannabis-related substances

Guidance for completing an application for permission to import medicinal cannabis and cannabis-related substances.

Resource type

Guidance

Introduction

The importation of medicinal cannabis substances subject to regulation 5 of the Customs (Prohibited Imports) Regulations 1956 is prohibited unless the importer holds a licence and permit issued by the Narcotics Control Section (NCS). A permit is required for each consignment that is imported whereas licenses are issued annually. A licence to import must be obtained before a permit can be granted. Information on obtaining a licence is available separately from the Office of Drug Control (ODC) website.

Permits are not granted to individuals for the purpose of obtaining medications for personal use. If you are an individual wanting to access medications that are prohibited imports you should consult your doctor and refer to the Special Access Scheme on the TGA website.

Permitted purposes for importing medicinal cannabis

An application may be made to import medicinal cannabis products for the following purposes:

Authorised Prescriber (AP) Scheme
Special Access Scheme (SAS)
Clinical Trials
Animal Studies
Laboratory or analytical testing
Cultivation under an ODC Medicinal Cannabis Permit.

Application requirements

Medicinal cannabis and its products (such as cannabis oil, extracts and tinctures) are regulated as medicines in Australia and are prescription only substances. Only delta-9-tetrahydrocannabinol is permitted for importation into Australia. All other associated isomers of tetrahydrocannabinol (THC) are not permitted for import for use in Australia.

Importers must specify the form of THC being imported when completing import permits and are now required to specify whether the cannabinoids are of natural or synthetic origin.

To apply for a permit to import controlled substances the application form titled ‘Application for permission to import cannabis and cannabis-related substances’ must be submitted to NCS. The guidance provided here will assist you in completing and submitting the application form.

Completing the application form

The table below identifies the required information for completing the permit application form:

Part of application form	Explanation of required information
1. Importer information
Licence holder’s name	Provide name of the registered Licence Holder.
Import licence number	Provide Import Licence number.
Licence expiry date	Provide the expiry date for the Import Licence.
Company name	Provide the name of the company that has been licenced to import.
Approximate date of import	Indicate the expected import date for the consignment if the import permit is issued.
Company address	Provide the physical address of the company that holds the Licence. The address must match the address that is listed on the Licence.
Postal address	Provide the postal address to which you would like the import permit sent. Permits will be sent by standard mail unless a self-addressed express post envelope accompanies the application.
2. Exporter Information
Overseas exporter’s full name	State the full name of the overseas exporting entity.
Overseas exporter’s address	State the physical address of the overseas exporter to be displayed on the import permit (the exporting address cannot be a PO Box).
3. Use of Medicinal Cannabis
Purpose of import	Select one box only Sponsored Special Access Scheme (SAS) Select this option if the product is in finished dosage form (e.g. 30ml bottle or 15g pack) that will be supplied under the Special Access Scheme. Authorised Prescriber (AP)– Select this option if the product is in finished dosage form (e.g. 30ml bottle or 15g pack) that will be supplied under the Authorised Prescriber Scheme. CTN/CTX or ARTG – Product is in finished dosage form for supply to a clinical trial under a CTN/CTX or a finished product with an ARTG number. Cultivation – Seed or plant material for use under your cultivation permit. Manufacture (or Compounding) – API material that requires additional manufacture or compounding into final dosage form before supply under SAS, AP CTN/CTX occurs. Laboratory or Scientific Research – Material that will be used for laboratory or research purposes only.
4. Trade Name and Overseas Purchase Order
Trade name	Provide the trade name of the goods, if applicable.
Purchase Order Number	Insert overseas purchase order number Attach copy of purchase order with application
5. Cannabis Flower/flos – Only complete if importing cannabis in flower or bud form
Examples: Cannabis Flos (or Flower) for supply under SAS/AP

Cannabis Flower for manufacture or compounding into a finished product

6. Cannabis related substances (e.g. extract, oil, THC, Delta-9-THC, CBD)
Raw Material API or Finished Goods	Refer to point 5 for the definitions of API and Finished Goods.
Origin of cannabinoids	Indicate whether the cannabinoids are of Natural or Synthetic origin.
Concentration/Strength	Indicate the concentration/strength of the major cannabinoids For raw material: Express each cannabinoid as a percentage (%) For finished goods: Express each cannabinoid in milligrams per millilitre (mg/ml) Wafer/sublingual film: Express each cannabinoid in milligrams (mg)
Form of substance	Indicate the form of the finished goods, for example capsule, cartridge, oil, seed etc.
Pack type and size	Provide details on the pack type and the size in metric units only API material: for example 1kg pack Finished goods (single units): for example 30ml bottle or 15g pack Finished goods (multiple units): for example 10mg wafer, pack of 50 Cannabis seeds: for example 10 packs of 50 seeds
Number of Packs	Specify the total number of packs/bottles (as defined above) that make up the proposed shipment. For example: 20 if you are seeking 20 x 1kg packs 500 if you are seeking 500 x 30ml bottles 1,500 if you are seeking 1,500 x 15g packs 100 if you are seeking 100 x packs of 50 wafers (5,000 wafers total) Net weight of seeds.
Examples:
THC/CBD for supply under SAS/AP
CBD for manufacture or compounding into a finished product
Samples for laboratory use
Seed for cultivation

7. Declaration and Consent
Make sure you read and understand the declaration and consent. Sign the application form. Complete the contact details of the person signing the form. The form must be signed by the licence holder or a person that the licence holder has authorised in writing to make applications under the licence.

Submitting your application

You can submit your application in the following ways:

Mail	Narcotics Control Section Office of Drug Control GPO Box 9848 Canberra ACT 2601
Email	NCS@health.gov.au

The NCS endeavours to process applications for permits within 20 business days from the date of receipt of a viable application form and the required supporting documentation.

While a very high proportion of applications are processed within 10 days, there will be times where high demand for permits may result in slightly longer processing times. Application forms that contain incomplete or incorrect information will be returned to you for amendment, resulting in delays in processing.

It is the responsibility of the importer to ensure that the triplicate copy of the permit is completed at the time of importation and the hardcopy returned to NCS.

It is responsibility of the importer to return the endorsed triplicate copy to NCS no later than 14 working days after the importation has occurred. Failure to comply with this condition may result in cancellation of import licenses.

Unused or expired permits must be returned within 14 days.

Supporting documents

Guidance: Applying for permission to import medicinal cannabis and cannabis-related substances [PDF, 284.13 KB]

Topics

Medicinal cannabis

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