7 July 2017

Export

To ensure that sufficient product is available to address the needs of Australian patients, export of domestically grown cannabis or medicinal cannabis products will not be permitted at this time.

Import

The import and export of medicinal cannabis products between countries, including those made from low THC cannabis, is tightly controlled and subject to international drug conventions. Approval must be granted by the national governments of both the importing and exporting countries before shipment can occur.

Food grade/nutritional products derived from hemp may not meet Australian manufacturing requirements.

Per patient imports

If a medical practitioner considers a medicinal cannabis product to be suitable for a particular patient, they can either:

  • If, in their medical opinion, the patient fits the definition of a Category A patient, and they wish to use Special Access Scheme (SAS) Category A (SAS A), and they have relevant approval from their state/territory health department, prescribe the product and then seek to import it. The doctor or the dispensing pharmacist must have an import licence and apply for import permission. See Licence and Permit applications forms for more information. In seeking to import, evidence must be provided of the state/territory approval to prescribe if required in that jurisdiction. It is also important to note that the product to be imported should meet relevant quality standards (see Access to Medicinal Cannabis Products on the TGA website for information and advice concerning quality standards).
  • If the patient does not meet the definition of a Category A patient, or does meet the definition of a Category A patient but the doctor does not want to use SAS A, they must seek approval from the TGA under the SAS Category B or be granted 'Authorised Prescriber' (AP) status by the TGA. The doctor must also ensure the product and treatment is approved under the law of the state or territory in which the patient resides, as well as get TGA approvals. Evidence of these approvals will be required for the import application to the Office of Drug Control.

Once the doctor obtains SAS Category B approval or is an Authorised Prescriber and can demonstrate the product and treatment is permissible under state or territory law, they (or a person on their behalf) can seek permission to import by completing relevant licence and permit application forms.

The Department of Health has recently reviewed the process of importing medicinal cannabis products for doctors to prescribe under the Special Access Scheme Category B (SAS B) and Authorised Prescriber (AP) pathways.

Note: these imports are allowed only because there is a check on their use prior to prescribing undertaken by the TGA. Products imported under the sponsored importation policy cannot be supplied under SAS Cat A.

Medicinal cannabis products are currently only available through importation while the Australian domestic cultivation scheme is being developed.

An importer may seek import approval of medicinal cannabis products before SAS B approvals and AP requests, which will allow for supplies of medicinal cannabis products to be available in a more timely fashion.  This does not change the requirements for approval through SAS B or AP, but reduces time taken from approval to supply. Supply of medicinal cannabis products will remain a controlled process and there are a number of strict conditions that will be placed on importers and suppliers around what types of medicinal cannabis products may be imported and supplied, and how.

The imported medicinal cannabis must be held under direct control of the importer until the goods are authorised for supply under SAS-B or AP.

It is envisaged that these imports will provide a temporary solution to improve the timeliness of supply while the domestic cultivation and manufacture scheme comes into effect. Therefore, the requirements around security, quality of products and compliance with appropriate Australian expectations around manufacturing practice and secure distribution are expected to be mirrored for sponsored importers.

Sponsors (importers) will be expected to be able to demonstrate compliance with a number of conditions in obtaining an import licence under this exemption. These conditions arise from a number of regulatory requirements under therapeutic goods, narcotic drugs and customs legislation and the requirements of the Single Convention on Narcotic Drugs 1961. Sponsors will need to be able to demonstrate a potential supply chain through SAS-B and AP, and meet any State or Territory Requirements.

As well as conditions standard to that for all imported drugs under Regulation 5 of the Customs (Prohibited Imports) Regulations 1956, sponsors who intend to import in advance of SAS-B and AP will have the following statutory conditions imposed under Item 1 of Schedule 5A of the Therapeutic Goods Regulations 1990:

  1. Supply of medicinal cannabis must be in accordance with the relevant notification, approval, authorisation or prescription - SAS B, AP, clinical trials or through state or territory controlled public hospital pharmacies.
  2. Storage of medicinal cannabis must be in a secure warehouse or other properly secured area under the control of the sponsor
  3. Destruction of unused medicinal cannabis products must occur 12 months after importation.
  4. Records of all activity relating to the source, supply, storage and destruction of medicinal cannabis products must be maintained and provided to the Department of Health when requested, as well as quarterly. The records will include SAS B approval and, if necessary, prescriptions. The Department of Health will review these records.

In addition the importer/supplier may be subject to audits by the Department with respect to quality of the products imported. It is expected that, when requested, sponsors will be able to demonstrate that product imported has been manufactured or prepared to an equivalent standard of quality. The Therapeutic Goods Administration, which is part of the Department of Health, has published a Guidance on manufacturing standards of medicinal cannabis for supply under 'approved Access' provisions that governs the quality of medicinal cannabis products manufactured in Australia.

The importer must also be aware that cannabis is strictly controlled under international drug treaties. Where possible the importer should check that the company/person who intends to export to Australia is licensed by the overseas government at the Federal level. The Department of Health may not be able to process applications if the export is not permitted by the overseas government.

If you have any questions concerning import, manufacture or cultivation please review the information on our website at www.odc.gov.au

For matters concerning import and manufacture email the Drug Control Section at dcs@health.gov.au. For matters concerning cannabis cultivation or production email the Medicinal Cannabis Section at mcs@health.gov.au

The following pages may be of use: