Part 2: Want to sell Cannabis (legally of course) – Everything you need to know

If you are interested in becoming a licenced producer or seller of cannabis, here’s everything you need to know about the changes to Australia’s narcotic drug licencing.

Cannabidiol (CBD) similar to tetrahydrocannabinol (THC) is derived from a cannabis plant however unlike THC, CBD is not psychoactive and contains medicinal properties.  From 2021 the Therapeutic Goods Administration (TGA) has permitted the sale of low-dose CBD (a maximum of 150mg per day) to be supplied over-the counter by a pharmacist without a prescription. However, there is a catch. No product containing CBD has been approved by the Australian Register of Therapeutic Goods (ARTG) for pharmacist sale. So, whilst CBD can be sold over the counter currently no drug has been approved for this kind of sale. This decision came to fruition following a safety review of CBD by the TGA where they assessed current clinical literature to investigate the effects of low doses of CBD and as a result down-scheduled the substance from Schedule 4 (Prescription medicine) to a Schedule 3 (pharmacist-only medicine).

 

How to get a licence to cultivate or manufacture medicinal cannabis?

The Narcotic Drugs Amendment (Medicinal Cannabis) Act 2021 (the Act) commenced on 24 December 2021, detailing the changes for licences for medical cannabis regulation. The primary change under the Act was for licences to adopt a single licence model, consolidated from the previous structure of three separate licences – cannabis research licence, medical cannabis licence and manufacturer licence, into one. This licence will be granted for an unlimited period however, can be subject to suspension or revocation in accordance with the Act.

A licence will contain the certification and registration requirements by the business whereby a medicinal cannabis licence can only be granted for medicinal or scientific purposes. A medicinal cannabis licence will authorise the licence holder to cultivate cannabis, remove flowers or fruiting tops from the plant or to transform cannabis into a drug or extract. An applicant can apply for a licence at any time, however once you receive a licence, you must apply for a permit. You are unable to commence business activities until you have secured both a licence and the relevant permits. In addition, there is a statutory obligation for all licence holders to pay an annual licence charge whereby non-payment can result in revocation of the licence. This annual charge is subject to indexation resulting in minor increase applied at the beginning of each financial year.

In order to ascertain a licence applicant must:

• Be a fit and proper person
• Provide that there is a producer or a manufacturer who will buy any raw materials you produce
• Provide details of your business and proposed cultivation site
• Complete the required form and pay the prescribed fees.

You can apply for a licence either as an individual or for a body corporate but please note that application assessment can take up to nine months to provide a decision on the outcome of your licence during which the application fee is non-refundable. The approval of your licence is granted by the Australian Government, Office of Drug Control in conjunction with the TGA.

If your licence is approved, you will then be required to obtain the relevant permit indicative if you wish to produce or manufacture cannabis.

 

Gummies

The legal status of cannabis gummies differs across different Australian jurisdictions. For example, in most Australian states cannabis products for medical use are permitted if accompanied by a proper prescription issued by a Doctor or medical practitioner. However, in the Australian Capital Territory possession of small amounts of cannabis for personal use has been decriminalised unlike in other jurisdictions, however the sale and purchase of cannabis is illegal in all Australian states and territories.

Australia has seen an increase in consumption of cannabis gummies which are a chewable treat however, there are guidelines surrounding purchase and consumption of these cannabis infused products which are as follows:

• You must have a valid prescription from a Doctor or an authorised prescriber.
• You can only obtain gummies from pharmacists or authorised suppliers.
• You should only consume cannabis gummies in a private place such as your home.

 

Oils

CBD oil is a popular natural remedy for many ailments including relaxation and pain relief. The TGA places cannabis oil into two categories: hemp oil and hemp seed oil. CBD oil is classified as a hemp oil and is defined by the TGA as extracted from a cannabis plant and containing both CBD and THC. In contrast, hemp seed oil does not contain CBD or TCH.

Currently, CBD oil falls under the umbrella of medical cannabis and cannot be sold over the counter but instead requires a healthcare professional’s prescription. The Office of Drug Control regulates the importation of hemp products whereby in order to import CBD oils from overseas, you are permitted to have a licence and a permit prior to importing.

Ultimately as cannabis laws differ between jurisdictions, is important to be aware of the laws which impact you. If you need legal advice or guidance, please contact us here at Chamberlains to assist you in gaining a cannabis licence if you wish to become a producer or manufacturer.

 

* This article was prepared with the assistance of Zara Smith