Since 2016 medicinal cannabis has been legal, however the process involved when applying for an ODC medicinal cannabis licence is lengthy and confusing.
To help alleviate some of this confusion, this blog will address a couple of the most common questions I get asked as a cannabis consultant, namely:
- What is the process involved when applying for an ODC cannabis licence?
- What are the pitfalls?
Thus the main core of this blog covers what you can expect when applying for an ODC cannabis licence, what you need to have in place, and what to watch out for (and is an accurate summary as of May 2020, of the knowledge I’ve gained so far).
1. What is the process involved when applying for an ODC cannabis licence?
The overarching process involved when applying for an ODC medicinal cannabis licence is outlined below:
- Raise your ODC application – include your standard operating procedures, informed consent forms and letters of intent from vendors and service providers.
- Submit your application (a whole other topic).
- Receive an invoice – usually sent a week after submission by the ODC .
- Receive an initial 14J – approximately 2+ weeks after submission, the ODC will send you an initial 14J in which they will ask questions to clarify their understanding of your application.
- Wait and respond – after the initial 14J, the waiting period is ~1 year+ during which the ODC will send out more 14Js and request more information.
- Licence(s) issued – if they are happy, the ODC will issue your licence(s). Note that this does not actually let you grow anything.
- Construct your site (if not already constructed).
- Perform a formal security risk assessment – this is performed by an independent security consultant who has registration or licensing in security in at least one State/Territory. They will help you prepare a Security Risk Management Plan in compliance with AS/NZS ISO 31000:2009.
- Apply for a poisons licence (or equivalent)- this requirement varies depending on your State/Territory department of health, and whether or not you are planning on importing seed (see item 12). If this relevant, you will need to provide a Security Risk Management Plan as a part of the application.
- Get audited by your State/Territory health authorities – if no problems are detected, they will issue you a poisons licence.
- Get audited by the ODC – if there are no issues, you can put in applications for cultivation permit(s). At this stage you need to:
- identify exact strains and quantities you intend on generating onsite for: commercial production, and ongoing stock plants (e.g. mothers or tissue cultures) – these are two separate permits
- you also need to have contracts and commercial agreements in place with your vendors and customers as evidence of the established supply chain.
- Receive Cultivation permits – if you’re sourcing seeds locally, you are good to grow, but, if importing – you need to apply to:
2. Additional licensing and regulatory considerations
2.1 Poisons licencing
To complicate the process involved when applying for an ODC medicinal cannabis licence, you also have to consider your state poisons requirements.
The ODC guidelines do stipulate some security requirements for secure storage and waste handling, however you also have to consider State/Territory regulations as well – some have deferred to the ODC, while others require that you comply with both Federal and State/Territory legislation:
|NSW||Poisons and Therapeutic Goods Act 1966
More information on state requirements here.
|VIC||The Drugs, Poisons and Controlled Substances Act 1981
More information on state requirements more info for the Victorian medicinal cannabis industry.
|WA||Medicines and Poisons Act 2014
More information on state requirements here.
|QLD||Health Act 1937
Note that these are to be superseded by new legislation due to commence on 27 September 2020 (unless proclaimed earlier).
|TAS||Poisons Act 1971
|NT||Medicines, Poisons and Therapeutic Goods Act 2012
While these state poisons regulations are strongly influenced by the TGA Poisons Standard, there are slight regulatory nuances per state that could trip you up later down the track if you don’t factor them in early.
Within the TGA Poisons Standard, Schedule 8 is the generally accepted category for cannabis plant material however, while cannabis waste falls under “any part of the plant”, waste cannot be deemed “cannabis prepared for medicinal use” and thus it technically falls into Schedule 9!
Thankfully, however, most have been interpreting cannabis waste as Schedule 8 as it is generated under the legal scheme. Unfortunately, this adds another complication as many State/Territory requirements often specify that Schedule 8 materials must undergo controlled destruction either by, or witnessed by, an authorised person or medical professional. This is obviously impractical from an operational perspective.
Unfortunately, State/Territory requirements for storage are better suited to hospital or pharmacy settings, leaving the guidance for cultivators and manufacturers hazy at best.
Just to complicate matters, some states assess security requirements for a poison on a case-by-case basis depending on:
- the schedule of material
- the quantity of material
- the level of risk posed by that material.
Therefore, once you get an idea of your site capacity and your strains, you may need to contact the state prior to construction to make sure you have the right plans for storage in place (either before you submit the application at step 1, or prior to starting construction at step 7).
2.4 Good Wholesaling Practices
Another thing that will greatly impact the process for applying for an ODC medicinal cannabis licence, is that State/Territory storage and waste handling requirements are also directly influenced by the TGA standard for Good Wholesaling Practices.
So, unless specified otherwise, S8 controlled drugs will require the following to be in place:
Even as a cultivator you may need to have good wholesaling practices in place because you are storing a medicinal product (or precursor).
3. The pitfalls in summary…
- Don’t underestimate the time it takes for a licence application.
- Make sure you check where the boundaries lie between the Federal and State/Territory licences (and which ones you need)
- If applicable, check your medicinal cannabis storage and destruction plans are compliant with your state poisons requirements.
- Consider whether or not you will need to have a Quality system in place to comply with Good Wholesaling practices. Obviously if you are manufacturing a finished product, you will have to comply with GMP.
4. Future plans
A critical piece of information to bear in mind is that the TGA are currently reviewing two different proposals for amending the Poisons Standard that will mean:
- low-THC plant material is down-scheduled to Schedule 4 and no longer categorised with the high-THC strains in Schedule 8, and
- low doses of CBD will be down-scheduled, potentially to S3 (over-the-counter complementary medicines).
This will dramatically increase the product range available for manufacture, increase the availability of access to those product, and, if you are focussed on low-THC strains, is likely to reduce your initial starting costs given the lower security requirements. (Just a few things you may be interested factoring in to your business plan prior to applying for an ODC medicinal cannabis licence!)
However despite this downscheduling, CBD cosmetics are still off the table due to the Therapeutic Goods (Excluded Goods Determination 2018). This regulation specifies that chemicals in S2, 3, 4 and 8 are not permitted to be included in cosmetics. I covered this in detail in a previous blog.
The medicinal cannabis licensing application process is lengthy and complex, but we are happy to help guide you through it.
If you liked this content and want to read more, the following blogs might be of interest:
- CBD oil and Hemp oil; the controversies and clarifications
- What is the difference between GMP and GACP?
- Cultivation of medicinal cannabis vs hemp