The research licence is needed for individuals and corporations who wish to possess cannabis and to conduct activities in relation to research involving cannabis. Before applying, 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 (e.g., in-house testing for THC and CBD, formulation, sensory studies/palatability, etc..).
A cannabis research licence activities may include but is not limited to sensory studies such as registering participants, conducting sensory and palatability studies, and having participants report on touch, smell, taste, colour/viscosity/opacity of cannabis or cannabis products slate for research use.
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; or
- 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; or
- 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 to be noted in the licence application are the proposed Licence Holder (if the applicant is an individual) and the 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, while the Responsible Person has the authority to bind the Licence Holder (often the CEO or Director of the organization, or someone delegated by that person). The Responsible Person is also 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 Alternate Heads of Laboratory if they are qualified to replace the Head of Laboratory. 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 (e.g., be both the Licence Holder and the Responsible Person), assuming they meet all the requirements.
Creating a corporate profile is an important part of the application and can be prepared for an individual or a corporation. Corporations must ensure that a profile for the organization has been created in the CTLS. To create a corporate profile, Directors and Officers of the corporation must create user accounts with Account IDs linked to the corporate profile.
Creating a corporate profile has additional requirements:
· The full legal name(s) of the organization.
· Its incorporation number with the certificate of incorporation.
· The business address of the corporation and contact details
· Controlling organizations (i.e., the “Parent Corporation”), if applicable.
· An organization chart, and personnel. Names and titles of senior management positions and any controlling entities or individuals, as well as relationships between these roles must be indicated.
Note that any controlling organization will be required to create a corporate profile. The Corporation ID of each controlling organization is also required. Once the appropriate Access IDs to the CTLS and corporate profile is completed, the main part of the application must be submitted.
Confirming licence ownership is about disclosing the proposed Licence Holder and Responsible Person, as previously discussed. The mailing address must be a Canadian address where the application will receive official mailed correspondence. Site and testing details identify the primary Canadian site at which the testing activities are proposed to occur. Testing processes are also disclosed for different forms of testing which may include testing for chemical contaminants (e.g., heavy metals); microbial contaminants such as yeasts, moulds and bacteria; cannabinoid content and potency; purity; pesticides; stability analysis (including expiry date), seed viability and other testing types.
The Site personnel section focuses on the qualifications of the Head of Laboratory and any designated Alternate Heads as these relate to the duties of their positions. 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.
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.
The physical security plan (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.
A number of regulatory requirements for record-keeping must be observed. 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 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.|