Would you like to open a psilocybin business in Canada? Our Canada Dealer License Consultants put together this how-to guide providing you actionable steps. At this time, the license allows your business to produce and distribute psychedelics through medical channels, such as for clinical trials, R&D, and for pharmaceutical and therapeutical purposes.
Given the current climate regarding psychedelics worldwide, high likelihood exists for the market to expand further into adult consumption for recreational purposes. Read further on how to obtain a Controlled Drugs and Substances Dealer’s License in Canada.
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Laws and Regulations
To fully understand the Health Canada program for psilocybin and other psychedelic controlled substances, familiarize yourself with the following acts and regulations:
- Controlled Drugs and Substances Act (CDSA)
- Food and Drug Regulations (FDR), Part G (Controlled Drugs) and Part J (activities with restricted drugs for clinical trials or research purposes)
In addition, Health Canada’s Office of Controlled Substances (OCS) will govern the program. Now that you know where to find the laws, let’s take a look at the timeline.
First, the program is open, with no deadline. You can apply at any time. Why wait?
The OCS reviews your complete license application, and if it is satisfactory, it will then conduct a facility inspection to ensure compliance with the Directive, CDSA and all associated regulations. The OCS states that it will issue its decision on new dealer license applications within 270 days from the date of receipt of a completed application.
Next, let’s look at the types of activities and substances that a dealer license authorizes.
Types of Licenses
First of all, the Dealer License authorizes you to conduct otherwise-prohibited activities such as the production, packaging, sale, sending, transportation and delivery of controlled psychedelic substances such as psilocybin, MDMA, LSD, and DMT. Import and export of these controlled substances is also allowed, but first you must have the Dealer’s License to apply for the import/export permit from Health Canada.
Your type of license is determined by your list of controlled substances and their associated activities in your application. In other words, you determine the extent of your substances and activities and once authorized, your license allows you to conduct such.
Finally, keep in mind that since psilocybin and psilocin are controlled under Schedule III of the CDSA, activities such as possession, sale and production are only allowed per the stipulations within Part J of the FDR.
Simply put, in order to win a license to operate a psilocybin business in Canada, you must submit the following SOPs and documentations:
- Physical Security Plan (floor plan, security template, security proposal) – Adherence to the requirements of the Directive on Physical Security Requirements for Controlled Substances (“Security Directive”)
- Identification, Documents in support of, and Criminal Record or Police Check of the Senior Person in Charge (SPIC), Qualified Person in Charge (QPIC) and any alternates (A/QPIC)
- Corporate documentation proof such as Certificate of Incorporation or patent
- Record Keeping Plan (Methods and samples of the proposed record keeping templates)
- Production Activities
- Packaging of Pharmaceutical Products
- Notice of Compliance (NOC), if applicable
- Drug Identification Number (DIN), if applicable
- Sample label for each package size of the new product to be marketed, and indication whether your licensed entity will be packaging its own product, for itself or for another company, or if it will be packaged by another company, which must be named.
Next, let’s take a look at the application and renewal fees, if awarded a license.
Fees are based on the substances that need to be listed on the license. In other words, if the controlled drugs and narcotics are intended for veterinary use only, the fee is $1,750. However, for manufacturing and production for human consumption, clinical trials and research purposes for psychedelics, the fee is $5,184 due upon renewal of your license. This Dealer’s License fee will increase annually by 2% on April 1.
However, if you are a new company, the Dealer License fee is deferred until the end of your first full calendar year of activities authorized under the license, or within 90 days after the day on which that first calendar year ends.
Tips for Winning Licenses (Steps 1-10)
Step 1: Read the Laws and Regulations
The first step to winning a Dealer License in Canada is to read the Laws and Rules. By doing so, you’ll understand the playing field and how to win a license for authorized activities with psilocybin and other psychedelics. It’ll also give you an idea of how the market is structured and how you may transfer and transport product, whether you want to do so domestically or internationally.
Step 2: Choose a license type
Secondly, you will need to choose which type of controlled drugs you will be dealing. Following that, you also need to choose the extent of your intended activities at your proposed site. Depending upon your choices, your Dealer License may authorize all or some of the following activities:
- Production of pharmaceutical products
- Production of base substance materials
- Packaging of pharmaceutical products
- Distribution and sale
- Sending, transportation and/or delivery
In addition, the Dealer License application requires you to disclose Other Activities with your named controlled substances. These may include:
- Laboratory analysis
- Research and Development
- Clinical Studies
- Distribution under SAP only
- Import and Export
- Other activities (which must be specified)
If you need help deciding upon the extent of your controlled substances activities, move to the next step and engage our Canada Dealer License consultants.
Step 3: Engage our Canada Dealer License consultants
Thirdly, our team has won several Health Canada ACMPR licenses for our clients. We are prepared to do the same for business entrepreneurs seeking a Dealer’s License for psilocybin and other Schedule III psychedelics. We can make your life easier! Let us do the heavy lifting for you.
Step 4: Form a business entity
If you haven’t already done so, now is a good time to form your business entity to apply for the Canada Dealer’s License. Your OCS application requires proof of your individual applicant status, as well as corporate documentation. Make sure you have this in order well in advance of your application submission.
Proof can be in the form of a copy of certificate of incorporation or a patent letter. In addition, you must provide documentation that you have registered with the province under your corporate name or any other name under which you intend to carry out the activities specified in your license.
Step 5: Build a team
The first step to build your team for your psilocybin dealer business is to ensure that your team displays expertise in psilocybin cultivation and manufacturing, and all activities for which you are applying for authorization. It is mandatory that your PIC, QPIC, and A/QPIC demonstrate this experience.
In addition, your team should demonstrate experience in business management, highly regulated industries, finance, microbiology, analytical chemistry, good manufacturing practices, and more. Also, your proposed QPIC must be a pharmacist or practitioner of medicine, dentistry or veterinary medicine. They must be registered with the provincial professional licensing authority, OR have a degree in an applicable science.
Do you have a team in mind? If not, contact our psilocybin consulting firm to learn more about our talent acquisition services.
Step 6: Develop a business plan with the help of our Canada Dealer License consultants
Once you’ve formed your entity and consolidated your team, you should begin developing your psilocybin and psychedelics business plan. A strong business plan will help you analyze the market for your distribution and plan your costs accordingly.
Use our clear and comprehensive psilocybin business plans to present to investors, build local support, and get a head start on your license application. A great business plan details your team’s expertise and long-term strategies. It will help you raise the necessary capital for your Canada psilocybin and controlled substances business.
Step 7: Raise Capital
It’s never too early to begin raising capital for your Canadian psilocybin business. Having crafted a business plan demonstrating your long term strategies, you are well on your way. However, raising capital takes time, networking, and a lot of energy.
Also, keep in mind that the Canadian program for controlled substances licensing will likely open from patient, hospital and research practitioners to recreational use for adults. You may want to raise capital in anticipation of expanding your licensed operations to supply such a market.
Step 8: Choose a location for your controlled drugs and substances dealer activities
As you’re raising capital, research locations for your prospective psilocybin activities. Keep in mind, a Controlled Drugs and Substances License (CDS License) is site-specific. You will need to obtain a separate license for each individual site that you intend to conduct the activities with controlled substances.
Furthermore, the application process divides location into three geographical regions. In addition, physical security is divided into 11 security levels. Each security level has a different requirement based on the applicant’s geographical location and the total value of controlled drugs and substances to be stored onsite at any given time.
Therefore, your choice of location affects the costs of your application fees as well as renewal fees, and ease of delivery to other licensed entities. If you are not sure where to best locate your controlled substances business, we can help you with site location.
Step 9: Garner local support
After you’ve identified property for your proposed psilocybin and other controlled substances business activities, you can begin building support at the local level and within your province. Additionally, start building relationships with local organizations indicating your intention to positively impact the community and other local businesses.
Along the same lines, letters of support from these organizations is beneficial in the eyes of Health Canada. The OCS will look for support and attestation you have received from provincial, municipal authorities, as well as any science, research and medical professionals.
Step 10: Write and submit an application with the help of our Canada Dealer License consultants
At last, it’s time to write and submit your application to the OCS. The Dealer License application form itself is straightforward. However, it does require several Standard Operating Procedures. We can help you write these, as well as handle all parts of the application process for you:
- facility design,
- team recruitment,
- local approval,
- construction management,
- equipment selection,
- training employees,
- packaging, branding, and more.
Engage our psilocybin business consultants to assist you with all that you need to launch your psilocybin business in Canada.
Conclusions from our Canada Dealer License Consultants
Lastly, if you’re ready to venture into the psilocybin and psychedelics industry, our psilocybin business consultants have the solution for you! From business planning to talent acquisition and application writing, we can help you prepare an application to win a dealer license, or several.
Our psilocybin and cannabis consulting firm has over a decade of winning cannabis licenses in the most competitive markets around the world. Reach out to us to discuss a winning strategy for your psilocybin and controlled substances business in Canada.
APPENDIX | Additional Information
Basically, the Dealer’s License authorizes licensees to conduct regulated activities with the psychedelic substance(s). In addition, it authorizes the licensee to supply product for the Section 56 exemption program, Special Access Program (SAP), and clinical trials conducted by qualified investigators.
Related resources from our Canada Dealer License consultants
Requests to the Special Access Program (SAP) – Psychedelic-assisted psychotherapy