Importing cannabis into Australia (SAS only) 

 

Cannabis, cannabis resin and cannabinoids are classified as controlled susbtances under Regulation 5 of the Customs (Prohibited Imports) Regulations 1956 (the PI Regulations). Under certain circumstances, medical practitioners and pharmacists can apply to the Drug Control Section of the Therapeutic Goods Administration to import "unapproved" cannabis medicines into Australia issued in accordance with provisions of Category A or Category B of the Special Access Scheme (SAS).  

 

As the importer, you must satisfy yourself that you are complying with all relevant Commonwealth and state/territory legislation. The issuance of an import licence/permit does not absolve the holder from his or her obligations to comply with the provisions of any law relating to the import and/or possession and supply of the goods under Commonwealth and state or territory laws. ​

 

• Licenses and permits are not granted to individuals to obtain unapproved medications for their own use. In this case, you should first consult your doctor.​

 

How to apply: Licence and permit application forms*

 

The import licence and permit forms are available on the TGA website in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

 

The links below will take you direct to the forms on the TGA website.

 

For a licence and permit to import an "unapproved" medicine containing cannabis, cannabis resin or cannabinoids use:

 

• Application for a licence/ permit to import drug substances (Special Access Scheme only) (pdf,130kb)

 

 

 

• Application for a licence/permit to import drug substances (Special Access Scheme only) (Microsoft Word,143kb)

 

 

 

Please Note:

 

The first page of the form is for the licence application.

 

The second page is for the permit application.

 

* You must apply for a permit for each consignment of goods.​

 

What to include with your application

All applications for a licence/permit to import a cannabis medicine in accordance with the SAS must attach the following supporting documentation:

 

• Category A - Notification Form Only: If the use of the cannabis you intend to import is in accordance with Category A of the SAS you are  required to attach the completed Category A notification form.  Please note doctors must also notify the Experimental Products Section of the TGA using a copy of the Category A notification form.   

 

• Category B - TGA Approval Letter Required: If the use of the cannabis you intend to import is in accordance with Category B of the SAS, the doctor must first obtain TGA treatment approval. Either the doctor or a pharmacist (the importer) can then apply for an import licence and permit.  The importer must attach the Category B treatment approval letter confirming that the cannabis treatment has been approved.

 

• State/Territory approval:  If the use of the cannabis you intend to import is a Schedule 8 or 9 cannabis you may first be required to obtain state/territory approval, and must attach the state/territory approval letter confirming that the use of the cannabis is permitted under state or terriotory law.

​

• Note: State approval should not be required for Schedule 4 cannabis products.

 

Submitting an application

Completed application forms, and any other required documentation should be forwarded to the Drug Control Section of the TGA by one of the following methods:

 

Email: DCS@tga.gov.au (link sends e-mail) (DCS prefered method)

Mail: Drug Control Section, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 Australia

Fax:

• Within Australia: 02 6203 1740

• Outside Australia: +61 2 6203 1740

 

Processing times

The DCS state that they endeavour to process applications within 5 working days from the date of receipt. However, while a very high proportion of applications are processed within this timeframe, there will be times where high demand may result in slightly longer processing times. The DCS of the TGA will send the doctor or pharmacist, their import licence and a permit for each consignment.

 

Note: Application that contain large numbers of substances, are incomplete, or contain incorrect information will be returned for amendment, resulting in delays in processing.

 

Tips on completing the import and permit forms

The information below has been obtained from the TGA website and will assist you in identifying the required information for completing and submitting the licence and permit application forms. Import licence and permits are valid only for the importer named on the application and may be revoked for non compliance with specific conditions.​

 

Ensure that you complete ALL fields, indicating 'nil' or 'not applicable' if required.

 

Licence application form (page one)

 

1. Applicant (Importer) details

Full Name of Medical Practitioner or Registered Pharmacist

Select your profession

Medicare Provider number - Provide your Medicare provider number or pharmacist registration number.

* Licenses and permits are not granted to patients to obtain unapproved cannabis medications for their own use. In this case, you should first consult your doctor.​

 

2. Business information

Company name: Full name of the company/business/practice that will be the licence holder. 

Street address: Provide the street address at which activities associated with your profession are carried out.

Postal address: Where you would like the licence to be sent.

 

Note: The DCS send Licences and permits by normal mail unless an express post envelope accompanies the application.

 

3. Declaration and consent

The form must be signed by the importer.* Ensure you:

 

• read and understand the declaration and consent

• sign the application form  

• complete the contact details of the person signing the form

 

*To authorise another person under a licence, the licence holder must use the form: Application to add/remove authorised person (import/export)

 

Permit application form (page 2)

 

Note: An import permit is required for each consignment of cannabis product proposed to be imported. ie a separate permit is required for each cannabis product.

 

1. Importer information

Licence holder's name: Full name

Company name: Full name of the company, business, or Practice that employs the importer.

Company address: Ensure this is the physical address of the company/business/Practice that employs the importer.

This will be displayed on the import permit.

Postal address: Where you would like the permit/s sent.

Import establishment ID No: Insert if known. The DCS assigns a unique identifier to each establishment which holds a licence to import.

Importer licence number (if applicable): Insert if known.

Point of entry: The planned entry point for import into Australia - Specify port, airport, city, and state.

Approximate date of import: Indicate the expected import date for the consignment if the import permit is issued.  If the exact date is not known, provide the approximate time period.

Expected import date:

 

Note: Permits will be sent by normal mail unless an express post envelope accompanies the application.

 

2. Exporter information

Overseas exporter's full name: Full company name as shown on the SAS Category Form or Category B approval letter.  

Overseas exporter's address: Physical address of the overseas exporter. This will be displayed on the import permit.

Export establishment ID No: Insert if known. The DCS assigns a unique identifier to each overseas exporter.

Mode of transport: Specify how the shipment will be transported to Australia (sea or air).

 

3. Patient details

Patient's initials: Please provide patient initials only.

Patient's date of birth

Type of application: Category A - to attach medical practitioners certification or Category B - to attach TGA approval letter  

 

4. Substance details

Description of goods: Include the controlled substance name of the goods to be imported, for example:  4:1 Cannabis oil, indica dried cannabis bud.

Concentration/Strength: Indicate the concentration/strength of the THC and/or CBD cannabis in the medicine, for example X mg THC/mL & y mg CBD/ml for liquids, or XX mg CBD/ml, or y grams dried cannabis plant material.

Note: The concentration should be in metric units.

Form of substance: Indicate the form of the finished cannabis goods, for example:

• cannabis oil - bottles

• cannabis oil - liquid capsules 

• cannabis plant material - dried bud

• cannabis tablets

Pack type and size: Provide details on the pack type and the size, for example:

• 100 mL bottle

• 24 liquid capsules plastic container

• 50 grams plastic bag

• 50 tablets blister pack

Total number of packs in shipment: Specify the total number of packs (as defined above) in the proposed shipment, for example:

• 5 x 100 mL bottles

• 5 containers of 24 liquid capsules

• 5 bags of 50 grams dried cannabis bud 

• 5 packs of 50 tablets

Total amount: proposed for import should be consistent with the treatment regime that has been:

• determined by the prescriber (Category A notification)

• approved by the TGA (Category B approval).

Drug code: Insert if known. This is an identifier the DCS assign to specific substances and preparations.

 

5. Declaration and consent

 

Ensure the form is signed by the importer/licence holder.

Ensure you:

• read and understand the declaration and consent

• sign the application form

• complete the contact details of the person signing the form

 

Giving false or misleading information is a serious offence under Division 136 and 137 of the Criminal Code 1995 (CTH).

 

Importer's responsibilities

 

It is illegal to import cannabis, cannabis resin and cannabinoids into Australia unless you hold a valid import licence, and permit for each connsignment.  The issuance of an import licence/permit does not absolve the holder from his or her obligations to comply with the provisions of any law relating to the import and/or possession and supply of the goods. 

 

As the importer, it is your responsibility to:

 

• satisfy yourself that you are complying with all relevant Commonwealth and State legislation.

• ensure that the original permit/s is forwarded to the Exporter for presentation to the Competant Authority in the country of export. 

• at the time of importation into Australia, ensure that the triplicate copy of the permit is endorsed by the Australian Customs and Border Protection Service.

• Return the endorsed triplicate copy to the Drug Control Section of the TGA no later than 14 days after the importation has occurred.

 

Failure to comply with these, or any other conditions, could result in the cancellation of import licences.

 

Applying for a TGA Import Licence (SAS)

 

•  A copy of the import licence and permit is forwarded to the overseas supplier, with payment of goods if requested.

• If the overseas company already holds an export licence, the goods can be sent by air express to Australia.  Note: Some companies for example in Canada already hold export licences and should only need to apply for an export permit. 

•  If the company does not hold an export licence they will need to apply for one through their relevant health and/or customs authority.

 

Please note​

• Overseas medical cannabis companies are under no obligation to supply cannabis to Australian patients. There are some countries that do not permit the export of their cannabis. Please ensure that the overseas medical cannabis company (Exporter) holds an export licence issued from the Competant Authority in the country of export, and is prepared to export the proposed consignment of cannabis to Australia.

• This information is issued as guidance only, and it is not intended as legal advice.