Importation of Medical Cannabis
The importation of medicinal cannabis is strictly regulated and is subject to international drug conventions. For such a product to be imported, it must be approved by both governments of the importing and exporting countries before shipment can occur.
The importer must also hold a licence and a permit from the Office of Drug Control to import and establish that they are permitted to supply the medicinal cannabis products. The importer will need to hold a Victorian licence that will allow them to obtain, possess, sell or supply the medicinal cannabis. Further, the application for a licence must be accompanied by an indication of the quantity to be imported and the reason for importation.
Only medical practitioners may obtain approval to import medicinal cannabis.
Special Access Scheme (SAS)
To utilise the SAS, the medical practitioner must consider the medicinal cannabis product to be suitable for a Category A patient, who is a patient that is seriously ill. A patient will be deemed to be seriously ill if they have a condition where death is reasonably likely to occur within a matter of months. If a medical practitioner considers a patient to fit the description of Category A, the medicinal cannabis may be prescribed and imported provided that the medical practitioner has an import licence and permit.
Medical practitioners are required to submit evidence in support of their applications. It is also important that the product to be imported should meet relevant quality standards.
If the patient does not fit into SAS Category A, or the medical practitioner does not want to use the SAS Category A, they may seek approval from the Therapeutic Goods Agency (‘the Agency’) using Category B of the SAS or be granted ‘Authorised Prescriber’ (AP) status by the Agency. Obtaining AP status allows the medical practitioner to supply those therapeutic goods for a particular condition or to a class of patients in their care. In order to gain AP status, a medical practitioner must have expertise in the condition that they propose to treat with the medicinal cannabis, ascertain the needs of the patient and monitor the outcome of the use of the medicinal cannabis.
The treatment or the product should also be approved under the laws of the relevant state or territory.
Once the medical practitioner obtains SAS Category B approval or is an Authorised Prescriber and can also demonstrate that the treatment or the product is permissible under the state or territory law, they can seek permission to import the product by completing the relevant licence and permit application forms.
An importer of the medicinal cannabis products may seek import approval before SAS and AP requests through sponsored importation. The medical practitioner is still required to gain approval from either of those pathways, however, the sponsored importation reduces the time taken for approval of supply.
The sponsor will need to comply with various obligations and conditions arising under the Therapeutic Goods Regulation 1990 (Cth). These include:
- The supply of medicinal cannabis must be in accordance with the SAS, the conditions imposed on an AP, for clinical trials or through controlled public hospital pharmacies.
- The medicinal cannabis must be stored in a secure warehouse or property controlled by the sponsor.
- The medicinal cannabis that has not been used after 12 months following importation must be destroyed.
- Records regarding the source, supply, storage and destruction of medicinal cannabis products must be kept and provided to the Department of Health quarterly as well as when requested.
- The medicinal cannabis that has been imported must have been manufactured and prepared to a high standard of quality.
Further, the sponsored importers are required to demonstrate compliance with a number of conditions arising from a number of regulatory requirements, such as Therapeutic Goods Act 1989 (Cth), Narcotic Drugs Act 1967 (Cth) (‘Narcotic Act’) and Customs Act 1901 (Cth), and the requirements of the Single Convention on Narcotic Drugs 1961 (‘Single Convention’), before obtaining an import licence.
The importers will also be required to demonstrate a potential supply chain through SAS and AP, and also meet any State and Territory requirements.
If you are interested in importing cannabis and require assistance with the licensing process, feel free to contact us for a free consultation on (02) 9262 5495 or (03) 8899 7870; visit our Website; Like our Facebook Page.
This article is written by Damin Murdock. This article is not legal advice and should not be relied upon as legal advice. All articles found on this website are intended to provide informative information, nevertheless, in many instances, legislation and case law has been simplified and/or paraphrased. If you would like personal legal advice based on your current circumstances, you should contact MurdockCheng Legal Practice for a free consultation.