The Narcotic Drugs Regulations 2016 was recently tweaked under the Narcotics Drugs Amendment (Cannabis) Regulations 2018 (Cth). Based on the changes, Australian producers will be able to export medicinal cannabis products to the world.

To the surprise of Australia medicinal cannabis producers, the Narcotics Drug Amendment includes two specific definitions:

1. “Cannabis”
2. “Cannabis resin”

What this means is that the newly amended Narcotic Drugs Act 1967 (Cth) will permit export of cannabis seeds and raw materials, as well as fully processed medicinal cannabis products. This news could put Australia on the map as one of the biggest exporters of medical-grade cannabis products, despite the fact a few restrictions may still apply.

The ODC will issue licenses and permits to export medicinal cannabis from Australia

The Office of Drug Control (ODC) was granted permission to issue the necessary licenses and permits for the exportation of medicinal cannabis products from Australia on February 8, 2018.

Products that have been developed under a Good Manufacturing Practice (GMP) license can be legally exported from the country, as long as they are registered in the Australian Register of Therapeutic Goods (ARTG). Medicinal cannabis products must be listed as “export-only” to be exported from Australia.

Back in April, the ODC published a paper titled “Guidance for cultivators and manufacturers of medicinal cannabis,” of which clearly states that cannabis resin, flowers, and leaves are not permitted under the latest regulations. Due to this slight confusion, additional explanation is required to determine if indeed the export of raw cannabis materials is allowed.

Medicinal cannabis exports from Australia must meet specific requirements

Australian law characterizes cannabis as a narcotic and medicinal product, therefore all medicinal cannabis products must meet requirements set forth in the Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989 before being exported.

If the following legislative requirements are adhered to, licensed producers can legally export medicinal cannabis products:

• Under the requirements of the Therapeutic Goods Administration (TGA), finished medicinal cannabis products intended for exportation must be registered with the Australian Register of Therapeutic Goods (ARTG)
• Producers of medicinal cannabis products must maintain the necessary ODC cultivation/manufacturing licenses, ODC export license, and ODC export permits.
• Exports of medicinal cannabis products must not impede Australian patients from gaining domestic access to the specific product

Exportation of medicinal cannabis products is legal in a small number of jurisdictions

The exportation of medicinal cannabis products has been legalized in a handful of other jurisdictions. They include Canada, the Netherlands, and Uruguay.

Israel is a pioneer in medical cannabis research and is anticipated to legalize global medicinal cannabis exports in the near future.

Although the aforementioned jurisdictions have permitted exports, the legislative frameworks are complicated, due to the fact the exportation of raw cannabis products (e.g., seeds) is outlawed.

With that being said, the Australian Federal government’s approach is desirable for producers in the sense that it is fairly transparent in comparison to other jurisdictions.