Exportation of Medical Cannabis
The ability to export medicinal cannabis was legalised in February 2018. There are certain requirements that must be complied with and only certain types of medicinal cannabis products can be exported. An export licence and permit must also be held by the exporter.
In order to export medicinal cannabis, there are specific requirements to comply with. These exports must:
- conform to the Narcotic Drugs Act 1967 (Cth) to ensure the exporter complies with Australia’s obligations under the Single Convention on Narcotic Drugs 1961 (‘the Convention’);
- ensure that the export is made to countries that are a party to the Convention;
- hold a licence and permit from the Office of Drug Control pursuant to the Customs (Prohibited Exports) Regulations 1958 (Cth) and comply with the conditions imposed on that licence and permit; and
- register or list the medicinal cannabis product on the Australian Register of Therapeutic Goods (ARTG).
Types of Medicinal Cannabis Products which can be exported
There are limitations on which products of medicinal cannabis can be exported out of Australia. The medicinal cannabis products that can be exported are:
- medicinal cannabis that was manufactured in Australia under a Good Manufacturing Practice (‘GMP’) licence;
- medicinal cannabis that is listed as an export-only product or registered in the ARTG; and
- extracts of medicinal cannabis that are not in FDF form and were manufactured under a Narcotic Drugs Act 1967 (Cth) licence.
Cannabis flowers, leaves or resin cannot be exported from Australia.
Application Process for Expert Licence
If the medicinal cannabis product meets these above requirements, the exporter can apply for a licence. The application process consists of entering the finished product into the ARTG and either varying an ODC licence if it was issued before February 2018 or applying for a new export licence and permit. Medicinal cannabis is both a narcotic drug and a therapeutic good, and therefore, the application for its export is split between Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC).
Entry into the ARTG
Medicinal Cannabis that is intended to be exported for commercial purposes must be entered into the ARTG under the name of a product sponsor, who is the person that is responsible for the exportation of the product and holds both an export licence and permit.
An entry into the ARTG can either be through registration or as a listing as an export-only product.
If the product is registered, this allows for the export of the medicinal cannabis product as well as the supply of the product within Australia. In the case of an export-only product, the medicinal cannabis product cannot be supplied but only exported.
Requirements for an ODC Export Licence
There are additional requirements when applying for an export licence. Essentially, the applicant must ensure that:
- they hold a licence that allows them to possess, supply and wholesale medicinal cannabis; and
- they can demonstrate steps they have taken to adequately supply medicinal cannabis to Australian patients.
The ODC licence will have a condition that requires the licence holder to maintain supply to domestic patients. To comply with this condition, it needs to be shown that the exporter will be able to supply the medicinal cannabis:
- under the Special Access Scheme;
- to authorised subscribers; or
- for clinical trials.
Compliance to this condition will be ongoingly monitored by the ODC.
Requirements for an ODC Export Permit
In addition to a licence, an exporter of medicinal cannabis must also hold a permit. The applicant must ensure that:
- the medicinal cannabis product is entered on the ARTG and no conditions exist that prevent the product from being exported;
- the medicinal cannabis product is authorised to be manufactured under the Narcotic Drugs Act 1967 (Cth); and
- the applicant has received an authorisation from the importing country.
If you are interested in obtaining a cannabis expert licence, 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.