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Cannabis Research Licence
The research licence allows an entity to conduct research on cannabis and cannabis products. Some of the authorized activities include:
- Sensory and palatability studies
- Participant studies researching touch smell, and taste
- Colour, viscosity, and opacity of cannabis or cannabis products for slate research
- Various other research activities
Before applying for a research licence, it’s important to determine if this licence is needed, as the applicant may already be authorized to conduct research activities under the terms of an existing licence.
The ability for cultivators and processors to test their own products is of immense value, especially when these can be samples prior to the sales of these products through the medical and recreational streams.
Cannabis Research could apply to any material studied that contains:
- Any part of a cannabis plant, including the phytocannabinoids produced by, or found in, such a plant, regardless of whether that part has been processed or not, other than a part of the plant referred to in Schedule 2.
- Any substance or mixture of substances that contains or has on it any part of such a plant.
- Any substance that is identical to any phytocannabinoid produced by, or found in, such a plant, regardless of how the substance was obtained.
The term ‘cannabis’ does not apply to:
- A non-viable seed of a cannabis plant.
- A mature stalk, without any leaf, flower, seed or branch, of such a plant.
- Fibre derived from a mature stalk.
- The root or any part of the root of such a plant.
If the research being proposed involves the cultivation of industrial hemp plants only (i.e. cannabis plants containing less than 0.3% THC), you may only require an industrial hemp licence to conduct your research.
Key Personnel
There are a number of key personnel that need to be included in the research licence application, including:
- Proposed licence holder
- Responsible Person
Both persons must set up accounts in the Cannabis Tracking and Licensing System (CTLS) and obtain IDs. The licence holder will have overall responsibility for the licence.
The responsible person is the point of contact with Health Canada and is responsible for submitting the licence application. They are also responsible for the Licence Holder’s activities.
The Licence Holder may designate one or more individuals as the Resonsible Person. These persons must be identified in the application with their credentials. If the applicant is a corporation, its Directors and Officers must also obtain account IDs. Note that a single person may hold one or multiple roles within the company assuming they meet all the requirements.
Site Personnel
With a research licence there must be a Head of Laboratory and any designated alternate heads.
The Head must possess a degree in science related to the work being conducted, awarded by a Canadian university or by a foreign university recognized by a Canadian professional association. Confirmation that the Head will perform their duties at the site must also be submitted.
Cannabis Destruction
Destruction of cannabis lot or batch samples must be carried out in a manner that fulfills the requirements of section 43 of the Cannabis Regulations. Analytical testing licensees must destroy lot and batch samples and all cannabis obtained from those samples within 90 days of testing. If testing is not initiated within 120 days, the Licence Holder must either destroy the sample or distribute it to another analytical testing licence holder.
Physical Security Plan (PSP)
The PSP accompanying the application will feature a site description (including delineation of perimeter and storage areas); a description of how storage areas are designed to prevent unauthorized access to cannabis; as well as site and floor plans. If there are areas on site (including buildings) that will not be used exclusively by the applicant, these must be outside the proposed site perimeter.
Record-Keeping
There are a number of regulatory requirements surrounding record-keeping. The applicant will provide a copy of government-issued identification in order to verify the identities of the Licence Holder, Responsible Person, and Head of Laboratory. They must also include a signed and completed attestation form (found on Health Canada’s website) attesting to the manner of record retention regarding inventories; distribution, sale and export; destruction; and R&D activities. All information and documents must be retained at the site of the Licence Holder, with the attestation signed by the Responsible Person.
| Requirement | Required details to include |
|---|---|
| Complete site address | Primary site at which the research is proposed to occur. |
| Research grant identification | The grant number (if applicable). |
| Information on cultivation | Where cannabis is proposed to be cultivated, propagated or harvested (is applicable). |
| Identify whether cannabis will be synthesized | Will cannabis (i.e. cannabinoids, or chemical derivatives) will be synthesized or altered, whether using commercially available starting materials, bio-mass from cannabis or a combination or active ingredients isolated from cannabis that are unique to the plant that have been altered to form chemical derivatives (i.e. CBD-OAC, THC-OAC, etc.). |
| Description of research | A brief summary of the types of research activities to be conducted at the site(s). Please include whether studies will involve human subjects (e.g., clinical trials, palatability studies, etc.) and for in vivo research, please be sure to include a list of model organism(s). |
| Intent to sell | Indicate if there is intent to sell the physical product of the research (e.g., cannabis plants and/or cannabis plant seeds to a licensed cultivator, researcher, or cannabis drug licence). |
| Research type | Indicate the type(s) of research (e.g., in vitro, in vivo (animal), clinical trial, plant genetics, cannabis product development, non-cannabis product development, other) that is proposed to be conducted with cannabis or a combination of these. |
| For an in vivo (animal) study: obtain FDA authorization, if applicable | For those conducting research in animals, an Experimental Studies Certificate (ESC) may be required. |
| For a clinical trial: Obtain No-Objection letter for a clinical trial | Clinical trials conducted with cannabis using human subjects must first have a clinical trial application filed with Health Canada. A copy of the No-Objection Letter must be uploaded as part of the licence application if it is known at the time of application that a No-Objection Letter is required. |
| Research protocol | For the purposes of a licence application, a research protocol is a summary of the proposed research to be conducted and the amount of cannabis required for the research. Providing a clear summary document will facilitate the timely review of a research licence application. |
A Site Evidence Package and video attestation is not required for the submission of an application to become a licence holder for Cannabis Research.
Why Work with CannDelta?
CannDelta offers comprehensive support for preparing, submitting, and monitoring your federal cannabis license application, ensuring compliance and competitiveness. Our team includes experts with past experience at Health Canada, providing unparalleled insight into the regulatory landscape.
Business Plan Development
Build a solid foundation for your cannabis venture with business plans that meet Health Canada’s regulatory requirements and promote long-term growth.
Security Plan
Protect your assets and ensure compliance with thorough security plans that adhere to Canadian federal regulations.
Site Audits and Inspections
Stay proactive with detailed site audits. We identify potential issues and offer practical solutions to maintain compliance and efficiency, ensuring smooth operations.
Standard Operating Procedures (SOPs)
Enhance daily operations with tailored, compliant SOPs designed to facilitate smooth business processes and boost efficiency.
Marketing Plan
Make your brand stand out! We help you build your brand and create outreach strategies to establish your presence in Canada’s cannabis market.
Employee Staffing and Training Plan
Prepare your team for success with our recruitment strategies and customized training programs, ensuring your staff is well-equipped to excel in the cannabis industry.
