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Before you start applying for a cannabis research licence

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This page provides the information you should consider before applying for a licence.

1.0 Determine if you require a research licence

Before applying for a licence, you need to determine if your activities require a research licence.

Research activities with cannabis can include, but are not limited to, in vivo and in vitro studies, plant genetics, cannabis product development, research with humans such as clinical trials or non-therapeutic research on cannabis, and educational programs. If you or your organization holds another licence under the Cannabis Act, you may already be authorized to conduct research and development activities under the terms of that licence. Review your existing licence conditions or contact Health Canada for clarity.

If you wish to carry out analytical testing activities on cannabis (including cannabis products) as a service, you must apply for an analytical testing licence. If you only conduct analytical testing in support of your own research activities, only a research licence is required.

As per the Cannabis Act, cannabis (including hemp) means:

The term cannabis does not include:

If the research being proposed only involves the cultivation of industrial hemp plants (such as cannabis plants containing less than 0.3% THC), you may only require an industrial hemp licence to conduct your research. For more information, please see the Industrial Hemp Regulations and Industrial Hemp Licensing Application Guide.

Research with humans

Research with humans may require authorization under the Food and Drug Regulations and/or the Cannabis Regulations. Clinical trials with cannabis require authorization under both regulations, whereas non-therapeutic research on cannabis (NTRC) only requires authorization under the Cannabis Regulations.

Clinical trials

If you wish to conduct clinical trials with cannabis, you should obtain a No objection letter from the Office of Clinical Trials, in compliance with the Food and Drug Regulations, and apply for a cannabis research licence under the Cannabis Regulations. Refer to the Types of research with cannabis web page for additional information.

Non-therapeutic research on cannabis

If you wish to conduct activities in relation to non-therapeutic research on cannabis (NTRC), you must ensure that your research study meets the definition of non-therapeutic research on cannabis as per subsection 1(2) of the Cannabis Regulations.

If an applicant qualifies for a research licence that authorizes them to conduct activities in relation to NTRC, a No objection letter is not required to conduct the research. As such, there is no need to submit a Clinical trial application to the Office of Clinical Trials.

Note that you cannot apply for a research licence through a licence change to an existing cannabis licence, nor can a new cannabis licence (such as for cultivation or processing) be added to a research licence through a licence change. Licence holders wishing to apply for a research licence must submit a new licence application.

Existing institution-wide research licence (IRL) holders wishing to conduct activities in relation to NTRC must submit a licence change if they wish to conduct activities in relation to NTRC under their existing IRL. For information on amending your research licence, please send an email to sp-licensing-cannabis-licences-sp@hc-sc.gc.ca.

Sale of cannabis

A research licence won't automatically authorize the sale of cannabis. If you intend to sell cannabis as per paragraph 28(1)(b) of the Cannabis Regulations, you need to indicate the activity of sale when submitting your research licence application.

Important: The activity of sale is authorized in limited circumstances and is assessed on a case-by-case basis. For example, you may be authorized to sell cannabis plants and seeds for the purposes of genetic diversification as per paragraph 28(1)(b) of the Cannabis Regulations.

Refer to the Types of cannabis and industrial hemp licences web page for more information about selling or distributing cannabis with a research licence.

2.0 Determine your research licence model

To allow for greater flexibility depending on your organization and the type of research that you wish to conduct, there are three models of research licences that are available. They are divided into two categorizes as either "Project-based research licences" or "Institution-wide research licences":

Project-based research licences

Tip: Individuals affiliated with an institution should check with their institution's administration (such as the Vice President's Research Office) prior to applying for a project-based research licence, as they may already be covered for their research under an IRL.

Institution-wide research licences

Important: NTRC protocols must always be submitted to Health Canada for approval before starting a study. This also applies to IRLs.

Important: Applicants applying as individuals under the "Licence Ownership" section in the Cannabis Tracking and Licensing System (CTLS) should not choose institutional as their research licence model.

Determine what model best suits your proposed research activities prior to starting your application. The licence model selected will determine the various information requirements as you develop your application.

If your research plans do not fit cleanly within one of the above models, please contact Health Canada at sp-licensing-cannabis-licences-sp@hc-sc.gc.ca for clarity on the available research models so that you can make a decision that is most appropriate for your research model.

In practice, a university or college campus could be covered by one IRL. However, if a university has multiple campuses separated geographically, each campus would require its own licence. These licences could have the same responsible person.

Important: The Cannabis Regulations define a site as an area that is used exclusively by the licence holder and that consists of at least one building or one part of a building.

Important: In order for your application to be considered, your facility should be already built and the physical security should already be in place.

3.0 Determine your risk category (non-therapeutic research on cannabis only)

The NTRC framework is a risk-based framework. If you wish to conduct activities in relation to NTRC, you must identify the risk category of your proposed research study under the NTRC framework. NTRC studies can be classified as:

You may only select one risk category when applying for a research licence to conduct activities in relation to NTRC. If your research meets the criteria of multiple categories, you need to select the highest risk category that the study falls under. For example, if your study includes healthy adults aged 18 to 65 with no identified risk factors (normally a Category 1 or 2), but you're administering cannabis at amounts that are higher than what participants report typically using, this will render it a Category 3.

To help you determine the risk category of your proposed NTRC study, consider the following questions:

  1. Do the participants meet any one of the following factors?
    • Taking health products at study enrollment for the treatment or prevention of a pre-existing health problem that is not worsening in extent or severity (such as stable health problem)
    • Individuals who use cannabis at least once per month, but less than three times per week, for at least the past 12 months (such as occasional cannabis consumers)
    • Individuals who have experience using cannabis but have not used cannabis for at least the past 12 months (such as past cannabis consumers)

If the answer to any of the above is "yes," your proposed study may fall under Category 3. If the answer to all of the above is "no," proceed to the following set of questions:

  1. Does the amount, class or mode of consumption of cannabis meet any one of the following factors?
    • The amount administered and the frequency of administration are greater than what participants typically report using
    • The class of cannabis is different from that which participants typically report using
    • The mode of consumption is nasal, vaginal or rectal
    • The formulation of cannabis may be more harmful to participants than THC alone (for example, enhances the effects of THC)

If the answer to any of the above is "yes," your proposed study falls under Category 3. If the answer to all of the above is "no," proceed to the following set of questions:

  1. Does the study meet any one of the following factors?
    • More invasive methods of biological specimen collection (for example, indwelling catheters for continuous blood draws, biopsies) are used
    • Medical imagining (for example, CAT scan, MRI) is performed
    • Other types of medical interventions (for example, psychiatric evaluation) that a health care practitioner would normally execute are performed
    • The cannabis is co-administered separately with a substance set out in Schedule 5 of the Cannabis Act (for example, ethyl alcohol, nicotine)

If the answer to any of the above is "yes," your proposed study falls under Category 3. If the answer to all of the above is "no," proceed to the following set of questions:

  1. Does the study meet any one of the following factors?
    • The study involves the non-invasive collection of biological specimens (for example, urine, saliva, hair)
    • The study involves the use of non-invasive tools (for example, driving simulator, cognitive tests)
    • The study evaluates the physiological or psychological effects of cannabis
    • The amount of cannabis administered or distributed is more than the smallest amount needed to evaluate the organoleptic properties (such as taste, sight, smell or touch) of cannabis or the chemesthetic or sensory-emotive responses to cannabis (such as "consumer preference study")

If the answer to any of the above is "yes," your proposed study falls under Category 2. If the answer to all of the above is "no," your proposed study falls under Category 1.

For a comparison between each risk category based on factors related to the study design and characteristics of the participants, refer to Table 1. Classification into a risk category is based on a combination of factors. The factors listed in Table 1 serve as boundary limits for the categories. If at least one factor falls under a higher risk category, your study would fall under the higher risk category. To determine your risk category, it's recommended to start with the factors under Category 3. If your study does not meet any of the factors under Category 3, move on to Category 2 factors. If your study does not meet any of the factors under Category 2, your study falls under Category 1.

Important: In addition to other exclusions described in Table 1, note that NTRC does not include studies involving the participation of, or related to, young persons. A young person is an individual who is under 18 years of age. Activities conducted in relation to NTRC also remain subject to provincial and territorial laws, which may set higher age limits for cannabis possession and distribution than those indicated under the Cannabis Act.

Table 1: Comparison between each risk category based on factors related to the research design and characteristics of the participants
Factor Category 1 Category 2 Category 3
Level of risk Lower Medium Higher
Purpose of the research Only evaluate the organoleptic properties (such as taste, sight, smell or touch) of cannabis and/or the chemesthetic and/or sensory-emotive responses to cannabis (such as "consumer preference studies"). No evaluation of physiological or psychological effects. Study the physiological or psychological effects of cannabis on the brain or physiological effects on the body, including the pharmacology, pharmacokinetics, or pharmacodynamics of cannabis without any intent to evaluate or characterize any therapeutic effects.
Examples Ask participants to complete a questionnaire to describe the taste or mouthfeel of edible cannabis after a single bite or the taste and smell of dried cannabis after a single puff. Ask participants who normally consume edible cannabis to ingest an amount of edible cannabis similar to what they would typically consume, and then evaluate participants' performance in a driving simulation test. Compare the pharmacokinetics of edible cannabis with that of an inhaled cannabis extract by collecting blood samples from participants at several time points over a 24-hour period.
Eligible participants Adults who do not have any significant health problem(s) (such as healthy) between the ages of 18 and 65 (inclusive). May be any of the following:
  • Adults who do not have any significant health problem(s) (meaning healthy) older than 65 years
  • Adults older than 18 years taking health products (including prescribed medications, over-the-counter (OTC) medications and natural health products), at study enrollment, for the treatment or prevention of a pre-existing health problem that is not worsening in extent or severity (such as stable health problem)
Type(s) of cannabis Limited to cannabis that is identical or similar to cannabis class(es) that the participants usually use. The cannabis may contain cannabinoids that the participants do not usually use; however, if the cannabinoids are intoxicating, the participants must be regularly consuming delta-9 THC. Limited to cannabis that is identical or similar to cannabis class(es) that the participants usually use and that is identical or similar to cannabis products available on the legal, regulated market. The cannabis may only contain cannabinoids that the participants usually consume. Not limited to any class(es) or cannabinoid(s), on the condition that the cannabis is compliant with the Cannabis Regulations.
Mode(s) of consumption Limited to the same mode(s) of consumption typically used by the participants, excluding nasal, vaginal, and rectal use (for example, participants who only vape cannabis should not participate in research where cannabis is only smoked). Not limited to the mode(s) of consumption typically used by the participants, on the condition that the mode of consumption is compliant with the Cannabis Regulations.
Pattern of cannabis consumption Individuals who use cannabis a minimum of three times per week for at least the past 12 months (such as regular consumers). May include individuals with any history of cannabis use (such as individuals who have not consumed cannabis in more than 12 months to regular consumers).
Allowed amount and exposure
  • The amount of cannabis administered or distributed is the smallest amount needed to achieve the goals of the testing. Specifically, this means:
    • When the mode of consumption is smoking, vaping or any other form of inhalation, participants do not take more than three or four inhalations of cannabis smoke, vapour or aerosol per cannabis item.
    • For oral administration, participants do not take more than one or two bites or sips per cannabis item or activations of a cannabis accessory. Participants are not administered more than a total of 10 mg delta-9-THC per visit.
    • For topical cannabis, the applied amount does not exceed 1 g or 1 mL per cannabis item.
  • The total amount of cannabis administered and the frequency of cannabis administration do not exceed each participant's reported typical daily amount and frequency of cannabis consumption.
  • It cannot include co-administration of substances set out in Schedule 5 of the Cannabis Act (for example, ethyl alcohol, nicotine).
  • The amount of cannabis administered or distributed, and the frequency of administration are not more than what participants report typically using.
  • It cannot include co-administration of substances set out in Schedule 5 of the Cannabis Act (for example, ethyl alcohol, nicotine)
  • The amount of cannabis administered or distributed, and the frequency of administration may exceed the amount and frequency participants report typically using.
  • It may include the co-administration of substances set out in Schedule 5 of the Cannabis Act (for example, ethyl alcohol, nicotine).
Timing of measured effects Immediately after the consumption of cannabis Any time after use
Level of intervention No methods other than questionnaires focused solely on consumer preference May be any of the following:
  • Non-invasive collection of biological specimens (for example, urine, hair, saliva) with appropriate oversight
  • Other non-invasive tools (for example, questionnaires, driving simulator, cognitive tests) with appropriate oversight
Limited invasive methods (for example, blood draw) are allowed only at the start of the study for screening participants and with appropriate oversight		 May be any of the following:
  • More invasive methods of biological specimen collection during the study (for example, indwelling catheters for continuous blood draws, biopsies)
  • Medical imaging (for example, CAT scans, MRI)
  • Other types of medical interventions (for example, psychiatric evaluation) that a health care practitioner would normally perform

4.0 Familiarize yourself with the legislation

Familiarize yourself with the legislation listed below to see how they apply to your application.

Important: Consult the definitions in subsection 2(1) of the Cannabis Act and section 1 of the Cannabis Regulations. They will be used in these pages as well as all other documents for cannabis licence holders.

These laws, among others, could also apply to you:

5.0 Self-identify as an Indigenous affiliated applicant

Indigenous affiliation can include:

Self-identification is optional.

Health Canada offers the Navigator services to guide Indigenous affiliated applicants through the licensing process, and once they've become a licence holder.

There's a section to identify your application as Indigenous affiliated in the CTLS. Once this section is filled out in the CTLS, the Navigator service may reach out to you for an introductory teleconference after you've submitted your licence application.

If you'd like help before submitting your licence application, or if you have any questions about applying as an Indigenous affiliated applicant, email navig@hc-sc.gc.ca.

6.0 Business support

You can use the Business benefits finder. It brings together business supports from all levels of government. By answering a few questions, you'll get a list of the supports that fit your needs. This can include:

7.0 Prepare your site

You need to show that your site is fully built and meets all the requirements with security measures in place when you submit your licence application.

Important: Before preparing your site, you should check if your municipality's by-laws allow you to have a site with cannabis-related activities. You're also responsible for complying with all the applicable laws:

  • provincial or territorial laws (such as environmental laws)
  • municipal or local government laws, by-laws, policies, such as:
    • noise and light
    • electrical and fire safety
    • nuisance control for odour
    • zoning and building permits

The following section describes the things you should consider when preparing your site details for your proposed site.

A site is defined as an area that's used exclusively by the licence holder that consists of at least 1 building or 1 part of a building. You need to have at least 1 building on your site when you submit your licence application.

7.1 Site Details

7.1.1 Site perimeter

You need to define the site perimeter for your site. Only the licence holder can do activities on the site. If someone other than the licence holder uses any areas, rooms or buildings, they need to be outside of the proposed site perimeter.

If you're applying for an IRL, you will need to also identify the buildings, or rooms where you intend to conduct cannabis activities.

7.1.2 Licences are site specific

In general, cannabis licences are site specific. A project-based research licence model (one project, one site, or multiple sites) can allow for greater research flexibility (for example, for a clinical trial with cannabis at numerous hospitals). If you have multiple projects at multiple sites, submit a separate licence application for each project or for each site, or determine if your research projects can be conducted under an IRL.

7.1.3 Multiple licence holders at one location

There is no limit to the number of licence holders on a single piece of land or in a building. Multiple licence holders at 1 location are allowed if each licence holder is within a separate site or defined site perimeter. If you have multiple licence holders at 1 location, you will need to have a way to keep the activities separated between each site. For example, you will need to:

If there are multiple licence holders at 1 location, Health Canada may assess the risks associated with the increased amount of cannabis on your site. This can happen during the application process or after licensing, based on your current or future proximity to other licence holders. If the co-location of licences increases risks, Health Canada may add or revise conditions on your licence, or require more physical security measures for the site.

Tip: There can also be local municipal by-laws that limit the number of licensed sites within their jurisdiction.

7.1.4 Dwelling (Residence)

You're allowed to have a dwelling (residence) within your site. If your dwelling (residence) is within your licensed site, you can't have any cannabis related activities happening in it, including sale. You need to have a way to keep the activities separate. For example, you'll need to:

7.1.5 Storage areas

You should have enough storage areas to handle your intended activities and amount of cannabis that will be at the site. You'll need to have storage for:

The following aren't considered cannabis and don't need to be stored in the storage area:

Cannabis waste is still considered cannabis. This includes cannabis buds, leaves and branches. If you're not destroying cannabis waste, you'll have to store it in a storage area.

7.1.6 Cannabis waste destruction

You're not required to use a specific disposal method for cannabis. Your destruction method will have to meet the requirements described in section 43 of the Cannabis Regulations. This includes making sure people won't be exposed to cannabis smoke or vapour during destruction. An acceptable method can be shredding cannabis and mixing it with organic waste or soil before disposal.

If you destroy your cannabis on site, you need to destroy cannabis in the presence of at least 2 witnesses.

If you want to send your cannabis waste to be destroyed elsewhere, you can either:

Refer to the Cannabis Regulations for more information on document retention requirements for cannabis destruction. Note that for NTRC, documents must be retained for at least two years after the date on which the NTRC study ends.

7.2 Physical security

When applying for a research licence, you need to provide a site plan and a physical security plan (for project-based licences) or physical security measures framework document (for IRLs) indicating how operations areas at your site are designed in a manner that prevents unauthorized access. If you already have a cannabis licence at your site (such as a cultivation, processing or sales for medical purpose licence), you may already have some physical security measures in place.

Although specific physical security measures are not prescribed for operations areas under a research licence, you may wish to consider some aspects of physical security outlined in Section 5.1.3 of the Physical security measures guide for cannabis. Examples may include, but are not limited to, access restriction for all access points and physical barriers such as doors and walls.

Important: Depending on the type of activities proposed to be conducted with cannabis, the quantity of the cannabis on-site and the size of the proposed licence site, additional security measures may be required. Each submission will be assessed on a case-by-case basis.

8.0 Identify people

Important: Health Canada can only issue a licence after all mandatory people have been associated with the licence application.

There are specific people to identify in the CTLS during the application process. Each person needs to create an account in the CTLS, if they don't have one already. You can identify alternates, but they also need to have a CTLS account, if they don't have one already. Refer to the CTLS Getting Started Guide for more information.

8.1 Individuals who require user accounts in the CTLS when applying for a research licence and their roles and responsibilities

Tip: Someone can hold, at the same time, 1 or more roles, for 1 or more licences, at 1 or more sites. In this case, the employee can use the same CTLS account.

You'll need to make sure they can fulfill their duties by considering:

  • their hours of work at each site
  • if they're in a primary or an alternate role
  • if they're working at more than 1 site, the distance between sites
  • if they're working at more than 1 site, how they can do the work at all sites

8.1.1 Licence holder (If the application is for an individual)

8.1.2 Responsible person (Required for all licences)

Important: You can designate 1 alternate responsible person who is qualified to replace the responsible person. The alternate responsible person must submit the same documents and attestations as the responsible person.

8.1.3 Directors (Only if the applicant is a corporation)

8.1.4 Officers (Only if the applicant is a corporation)

8.2 Associated individuals

8.2.1 Consent to communicate

You may also choose to identify other associated individuals in the CTLS during the licence application process. You can identify someone who's allowed to communicate with Health Canada about your application and licence. For example, it can be given to a lawyer, a consultant, or another person associated with the application other than the responsible person.

This role is optional. If you identify a person who you'd like to allow to communicate with Health Canada about your application or your licence, that person should create an account in CTLS to be associated with the licence. If you've already submitted your application, you may email Health Canada requesting to add a new person to allow them to communicate with Health Canada about your licence.

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