Frequently Asked Questions

The Therapeutic Goods Administration's website has the 'Medicinal cannabis hub' which contains a lot of information for both patients and industry. The Office of Drug Control's website has information about medicinal cannabis licences. If you want to understand more about the industry side of medicinal cannabis in Australia, Mar Verde recommends looking at the websites of the main two industry bodies, the Australian Medicinal Cannabis Association & the Medicinal Cannabis Industry Association, or attending one of their annual conferences.

There are over 70 different companies currently supplying medicinal cannabis to Australian patients. As an unregistered therapeutic good, there are strict limitations on advertising medicinal cannabis, so this should be factored into your planning. To import medicinal cannabis, you usually need to have a licence to possess and distribute medicinal cannabis in the state your business operates before applying for an import licence. Mar Verde is not providing support on state licences at this time.

GMP is short for Good Manufacturing Practice and it is an internationally recognised system for ensuring that products are consistently produced. All medicinal cannabis products sold in Australia must be produced under this system. In Australia this is regulated by the TGA. Mar Verde does not provide support for GMP.

Everyone that Mar Verde knows in the Australian medicinal cannabis industry welcomes the idea of new entrants but they are honestly flat out. It is a growing industry that is highly regulated. Businesses are busy with their day-to-day as well as keeping up with regulations and compliance and staying on top of the Australian market and international trends. Do your research before you contact someone in industry. Both TGA and ODC are contactable via phone and email. There's a lot of information on the web as cannabis/medicinal cannabis is legal in other markets. Once you have this understanding, you'll be able to make better choices about who can help you. A word of advice, make sure that the person promising to help you actually has experience in the right area. The regulatory scheme for medicinal cannabis in Australia is quite complex, as is cultivating/manufacturing a medicine and, depending on what you want to do, you will need to rely on people with the right expertise.

Yes, noting there will be a fee depending on what you require. Please email us with your business history, a broad idea of your plans, and your availability.

A medicinal cannabis licence under the Narcotic Drugs Act 1967 is required for cultivating cannabis in Australia (and for manufacturing extract or extracting cannabinoids from plants or extract). The licence allows for supply of medicinal cannabis for scientific and medical purposes (but not directly to patients).

The ODC has a draft licence on its website from 2022. It's not exactly the same as licences that are currently being granted, but it will give you the general idea.

The cultivation of medicinal cannabis is highly regulated in Australia. There are significant costs involved which would make the pursuit of a medicinal cannabis licence more expensive than seeking a prescription from your GP. Additionally, medicinal cannabis licences and permits can only be granted for particular supply pathways - supply for personal use is not one of these.

You need to hold medicinal cannabis licence under the Narcotic Drugs Act 1967 before you can apply for a medicinal cannabis permit that would authorise cultivation, production or manufacture. In addition to having a licence, your facility will need to be close to completion before you apply for your first permit.

To actually begin operations, you'll need to be granted both a medicinal cannabis licence and the relevant permit (cultivation & production or manufacture). You can only apply for a permit once you hold a medicinal cannabis licence.

Once you've paid for a medicinal cannabis licence application, ODC states that it can take up to 195 working days a decision to be made. The decision may be to grant or refuse to grant a licence. Working days do not include weekends, ACT public holidays or the Christmas/New Year shut down period. This means a decision should be made on your application around 10 months after you apply, but this can depend on the time of year the application is submitted, the quality of the information provided and whether the ODC identifies any mandatory grounds of refusal.

After a licence is granted (and provided that all pre-requisite conditions are met), a licence holder can apply for their first permit. There is no timeframe provided by ODC for initial (first) permit applications, however they generally take at least 60 working days to process from the date the application is paid for, sometimes longer.

No. The decision maker must be satisfied about the suitability of the proposed location, the location is also tied into the facility and security designs. You must know where you will conduct operations and be able to prove to the ODC that you have access (or will have access at time of licence grant) to that location. This could be either through ownership or a lease.

There are no 'ODC approved plans'. The ODC grants a medicinal cannabis licence based on many factors, including the proposed operations, the location, the facility and security design, and the people involved. Plans are not approved in isolation, instead the licence application is considered as a whole.

The short answer is 'no', but this isn't a complete answer. The Office of Drug Control will look at whether an applicant is a fit and proper person, and an element of this is the applicant's financial background and financial circumstances. This doesn't have a fixed dollar amount attached to it - it relates to your overall plans and your company structure. There are also fees and charges associated with having a licence which you should be aware of. Mar Verde can go over these elements with you in more detail.

In the past, licence applicants were required to submit detailed procedures outlining their intended operations. This has changed so that at licence application stage you will need to provide some high-level policies and provide lower level procedures at the time of your initial permit application.

These documents should be personalised and tailored to the processes you are undertaking at your facility. Mar Verde finds that generic policies and SOPs that could apply to any facility are not particularly useful documents for licence holders.

Technically no, but you should have one. There are several questions in the licence application that relate to business operations and a well-thought-out business plan will assist in developing a solid licence application as well as being of use to you when developing your business. Mar Verde's experience is that those applicants with comprehensive business plans do better during the application process and initial start-up period than those without business plans, or with minimal plans.

Business plans should at a minimum include pricing and profit forecasts based on cultivation methods and anticipated number of plants and harvest material. You will also need to consider if the business can financially survive the first 6 months of operations and include significant expenses building fit out and security measures as well as ODC's fees and charges.

If you want to cultivate cannabis for industrial purposes (hemp) you will need a licence from your state or territory government. Mar Verde does not presently offer services to support such licences. Should you wish to grow low-THC crops for medicinal purposes, there are only minor differences in how the ODC considers the cultivation of low-THC and high-THC crops. These can be discussed should you choose one of our Services.

Yes, of course. The online form to apply is in plain English (and you can see it here).

Mar Verde Consulting provides a service that is tailored to you. Using our services can save you time (compared to the usual Office of Drug Control assessment process) as we can help you provide the right information, at the right time. We can help you focus your energy on the factors that will lead to a successful application. Engaging with us early can also save you money, as we can look at your circumstances and advise on common roadblocks in relation to past applications.

Mar Verde is a small business, and we carefully manage our workload to ensure that we always have time for our existing clients. That means that we sometimes say no to new work or offer more limited services if we think we'd be unable to provide our full attention.

It depends on why you'd like to talk. If you want to know more about Mar Verde and our services, we're happy to arrange a brief chat for free. If you have specific questions about medicinal cannabis licencing, the regulators' approach or your own particular circumstances then you will need to book a paid consultation session.

Most of Mar Verde's clients are existing licence holders – we provide support for their interactions with ODC, applications such as licence variations and permit applications, compliance matters, as well as being a sounding board for business plans or changes in regulation. We also work with new applicants for medicinal cannabis licences. We occasionally help with industry scanning, or reviewing proposed legislation related to cannabis.