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Prepare your information

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This page describes what you need to prepare before you can submit your licence application in the Cannabis Tracking and Licensing System (CTLS).

1.0 For corporations, cooperatives, partnerships

You'll have to create a corporate profile in the CTLS, if you don't already have one, if you're applying for the licence as:

This section provides the information you need to prepare when you're creating a new corporate profile.

1.1 Parent (owning) corporation

Any controlling organization is required to create a corporate profile, and directors and officers of that corporation need to have a CTLS Account. You need to gather the CTLS Account IDs of any controlling organization, if applicable.

1.2 Certificate of incorporation or business registration document

You need to prepare the following document depending on your organization:

1.3 Corporate organizational chart

You need to prepare a corporate organizational chart. It should include:

The chart needs to include each person's:

Important: Academic institutions don't need to create a corporate profile. If they are applying for an institution-wide research licence (IRL) they also need to submit an organizational chart. Refer to Section 2.11 for more information on the organizational chart for IRL applications.

1.4 Directors, officers, partners

Your directors, officers and partners need to each create a CTLS account. You need to gather their CTLS Account IDs to add later to your corporate profile.

2.0 Site details

2.1 Primary research site address

The address of your site must be a Canadian address. It cannot be a P.O. box. If you're applying for an IRL covering a large campus, the main institution's address or the main administrative building address may be used as the address of your site as long as the building is part of your site.

Important: For applicants for a project-based research licence to authorize activities in relation to NTRC, the primary site is the site where the study will take place. If there's more than one site in addition to the primary site, you need to add any additional addresses in the "Other Research Sites" section of the CTLS.

2.2 Research grant identification

You may provide your grant number as additional information, if applicable. This is optional for project-based research licence applications and IRL applications.

2.3 Information on cultivation

If you intend to cultivate cannabis, you need to provide information on where and how many cannabis plants will be cultivated. You must provide the latitude and longitude and specify whether you intend to cultivate cannabis or hemp, indoor or outdoor.

Tip: If you're applying as an IRL and don't yet have a specific location at your institution for cultivation or if you have multiple locations for cultivation, the latitude and longitude may be the geographic coordinate of the institution's main administrative building. You need to indicate in your physical security measures framework where all outdoor cultivation will occur.

2.4 Synthesis of cannabis

You need to indicate if your research activities will involve the synthesis of cannabis.

2.5 Sale of cannabis

You need to indicate if you intend to sell the physical product of the research (such as cannabis plants or cannabis plant seeds to a licensed cultivator, researcher, or cannabis drug licence). If you intend to sell cannabis plants or cannabis plant seeds, you need to complete a sales questionnaire.

Important: In general, you must destroy the cannabis in your possession once the research is completed unless you distribute it in a manner authorized under the Cannabis Regulations. In limited circumstances, a holder of a research licence may be authorized to sell cannabis plants or seeds as per paragraph 28(1)(b) of the Cannabis Regulations for the purpose of genetic diversification.

Tip: Distribution to other licence holders and select individuals is permitted for research licence holders and is not considered sale. For more information, see subsection 28(5) of the Cannabis Regulations and the Types of cannabis and industrial hemp licences web page.

Tip: In practice, an IRL can cover a campus (excluding publicly accessible areas). Cannabis may be transported between authorized buildings within a campus licensed under an IRL. You need to ensure that all steps necessary to ensure the safekeeping of cannabis are taken to transport the cannabis within the campus.

2.6 Production of cannabis

You need to indicate if you intend to produce cannabis. Produce is defined in subsection 2(1) of the Cannabis Act.

2.7 Maximum quantity of cannabis

You need to indicate the maximum quantity of cannabis to be stored at your site. This must be reported as a mass of equivalent dried cannabis. The dried cannabis equivalency is specified in Schedule 3 of the Cannabis Act.

If you intend on cultivating cannabis, you need to indicate the maximum number of plants that will be cultivated at your site. This number needs to be provided separate from the maximum quantity of cannabis to be stored at your site.

2.8 Research licence model

You need to choose the research licence model: project-based (single or multiple) or institution-wide. If you select 'single' under a project-based research licence application, the field "number of protocols" will be automatically filled. If you select ‘multiple’, you have to indicate the total number of protocols.

Important: If you're applying for a research licence to conduct NTRC studies, you shouldn't select 'multiple' as your research licence type. Research licences authorized to conduct activities in relation to NTRC are specific to a single protocol, except in the case of IRLs.

2.9 Research Types

You need to select which research types your research protocol or research project administration framework corresponds to:

Examples of non-cannabis product development including developing a lighting system used to grow cannabis plants or assessing the efficacy of pesticide products on cannabis plants. Developing cannabis formulations to make cannabis edibles is an example of cannabis product development. Examples of "Other" types of research include but are not limited to research activities involving teaching.

More than one type of research may be conducted under a single licence, except for licences that authorize activities in relation to NTRC as they are specific to a single protocol. If you're applying for an IRL, select all of the types of research that you expect will be undertaken. Note that observational studies may not require a research licence. Refer to the Types of research with cannabis web page for more information.

Important: If you're applying for a project-based research licence to authorize activities in relation to NTRC that involve other activities such as cultivation, synthesis or production of cannabis, you should provide information on the cultivation and indicate if you intend to synthesize cannabis or produce cannabis.

2.9.1 Non-therapeutic research on cannabis: additional requirements

If you're applying for a research licence to conduct activities in relation to NTRC, you need to submit additional application documents in the CTLS. Not all NTRC risk categories have the same document application requirements. The document application requirements for each risk category are listed below. Note that these requirements apply to both project-based research licences and IRLs. All applications to conduct activities in relation to NTRC need to include the application documents specific to their study category. Refer to Section 2.9.2 for more information on the application documents.

Importantly, only one NTRC study may be submitted per application in the CTLS for project-based research licences. For information on how to submit the required application documents, refer to the Apply for a licence section.

Category 1 study

The following documents are required in your application:

Tip: Before submitting a research licence application for Category 1, you may refer to the NTRC Category 1 Checklist to make sure that your proposed protocol meets all of the criteria. If during Health Canada's review of your research licence application, it's determined that your proposed study doesn't meet the criteria for Category 1, you may be asked to submit additional information to comply with the appropriate risk category requirements or submit a new research licence application. This may cause delays in obtaining a research licence.

Category 2 study

The following documents are required in your application:

Category 3 study

The following documents are required in your application:

2.9.2 Description of application documents

The following sections provide more information on the application documents required depending on your study risk category.

Application form

You need to complete the Application form which includes:

  • contact information
  • information about the study objectives and duration
  • attestation for ethical framework (Category 1)
  • Research ethics board, Institutional review board or Independent ethics committee information (Category 2 and 3)
  • site information
Cannabis information form

You need to complete the Cannabis information form (CIF). Provide as much information as available and known about the cannabis to be administered in the study. It's possible that certain sections of the form may not apply to your study (for example, the notice of new cannabis product (NNCP) number, or the manufacturing information of an accessory).

Important: You need to submit a separate CIF for each individual cannabis item or cannabis product to be used in your NTRC study at the time of application. However, if you're conducting a Category 1 study only, you may submit the CIF at a later date if the information is not available at the time of application, or if you wish to add cannabis items to your study after issuance of your research licence (for example, a contract research organization conducting a Category 1 study with multiple cannabis items). If you don't submit the CIF at the time of application, you need to submit it to Health Canada as a licence change in the CTLS before starting your study. For additional information on amending your research licence, email sp-licensing-cannabis-licences-sp@hc-sc.gc.ca.

The following information is required in the CIF:

  • Market status of the cannabis item to be used in the study:
    • not marketed, not notified
    • notified but not yet marketed
    • marketed
    • no longer marketed, withdrawn or discontinued
  • Licence holder name and associated licence number, the identifier or brand name, and the NNCP number, if applicable
  • Cannabis class and form
  • Net weight or volume of cannabis in the container or for multiple discrete units, the net weight of the cannabis in the immediate container
  • Cannabinoid(s) quantity and concentration as they appear on the cannabis product label and any other cannabinoids and their quantity or concentration, if known. Examples of other cannabinoids include:
    • Cannabichromene (CBC)
    • Cannabidivarin (CBDV)
    • Cannabigerol (CBG)
    • Cannabicyclol (CBL)
    • Cannabinol (CBN)
    • Delta-8-tetrahydrocannabinol (Delta-8-THC)
    • Tetrahydrocannabivarin (THCV)
  • Ingredient(s):
    • For cannabis products, you need to provide information about the ingredients as they appear on the product label or known to you
    • For non-marketed cannabis, you need to specify additional ingredient information including, if applicable:
      • flavour or colouring agents
      • any restricted ingredients (for example, cannabis topical with ingredients found on the Cosmetic Ingredients Hotlist or restricted by the Cannabis Regulations) and their quantities in brackets
  • Sensory attributes, such as flavour, scent, colour or shape
  • If the cannabis is not a cannabis product, anything that significantly distinguishes the cannabis or makes it novel, such as:
    • nano-formulated
    • synthetically produced through biotechnology
    • otherwise genetically engineered
    • new phytocannabinoid derivative(s) or isomer(s)
    • contains re-introduced terpenes

      Tip: For more information on novel cannabis products, refer to the Guide on composition requirements for cannabis products.

  • The maximum quantity of cannabis that is proposed to be possessed or produced by the applicant at any given time, broken down by site (if applicable) as well as the overall total. You need to express the quantity of cannabis as an equivalent of dry cannabis. Refer to Schedule 3 of the Cannabis Act for how to calculate equivalent amounts. Non-dried cannabis in solid or non-solid forms are considered concentrates when above 3% THC by weight.
  • You need to attest that the cannabis described in the CIF is obtained from a legal source. You need to attest that the cannabis used in your study complies with Good Production Practices
  • If an accessory will be used, you need to provide:
    • the name of the accessory and manufacturer (if applicable)
    • the make or model number (if applicable)
    • a description of the accessory, which needs to include:
      • the description needs to include characteristics such as the material(s), colour and shape
      • details about the dispensing of the cannabis if the product contains an integrated dispensing mechanism such as the volume of cannabis and mg of THC and other cannabinoids per activation. For example, for a cannabis vaping product: the accessory that contains cannabis is a 1.0-gram vaporizer cartridge, comprised of a glass chamber, 510 thread and black plastic mouthpiece
Abridged protocol

You're encouraged to use the Abridged protocol template when submitting a research licence application to conduct a Category 1 NTRC study.

The following information needs to be included in the abridged protocol:

  • Study objectives, including:
    • a clear statement of the study objectives
  • Study design, including:
    • the method for assigning participants to study groups (for example, randomized, blinding)
    • the total number of participants
    • the number of study groups
    • the number of participants per study group
    • the washout period between testing, when multiple testing sessions, multiple classes or multiple modes of consumption are included in the study 
    • the study duration from when the study opens for enrollment until completion of data collection
    • the duration of participation for each participant in the study
  • Study participants, including:
    • the method(s) for recruiting participants
    • the inclusion criteria (for example, age range bracket, pattern or frequency of cannabis use, health status)
    • the exclusion criteria
      • the following exclusion criteria need to be included in the study, in addition to any other exclusion criteria:
        1. individuals who are pregnant or planning to get pregnant
        2. chestfeeding or breastfeeding individuals
        3. individuals who are allergic to cannabis or any other ingredients in the formulation(s) of the cannabis
        4. individuals who have any serious clinically diagnosed conditions (for example, psychosis)
        5. individuals who are currently enrolled in another study or have participated in another study within <time frame> (for example, within the last three months)
        6. any other exclusion criteria that apply
  • Study procedures, including:
    • the type(s) of questionnaire(s) to be used
    • the methods for collecting results (for example, verbal, written)
    • the instructions that will be given to participants on how to fill out the questionnaire(s) or provide responses

      Important: The questionnaire needs to be attached as an appendix to the Abridged protocol. If more than one questionnaire will be used, attach each questionnaire as a new appendix.

    • any additional procedures and measures to limit exposure of the participants or the study personnel to cannabis, including:
      • procedures used to limit cannabis exposure to mitigate the risk of adverse reactions
      • measures taken to limit second-hand exposure to smoke, vapour or aerosol for the study personnel, other participants or any other individuals who may be exposed (such as a ventilated room), if applicable
  • Cultivation and processing of the cannabis (applies only if you're cultivating or processing cannabis to be used in the NTRC study)
    • a description of the cultivation and processing activities with the cannabis
    • the quantity of cannabis to be cultivated (include the number of plants) and the quantity of cannabis to be processed
  • Class(es) and form(s), mode of consumption, and amount of cannabis, including:
    • the class(s) and form(s) of cannabis
    • the mode(s) of consumption (for example, smoking, vaping, ingesting)
    • the amount(s) of cannabis per administration to a participant
  • Data analysis, including:
    • a description of how the data collected will be analyzed (for example, quantitative or qualitative analysis)
  • Safety monitoring plan and procedures, including:
    • how adverse events will be monitored, recorded and assessed, and the proposed strategy to mitigate the risks of adverse events
    • how serious adverse reactions will be reported as per the requirements in section 248.2 of the Cannabis Regulations
    • the criteria and procedures for withdrawing participants from the study
    • the procedures for making sure that participants receive proper medical attention after an adverse event if and when necessary
    • how participants will be followed up with after being withdrawn from the study due to adverse reactions
    • how participant safety will be protected throughout the study, including:
      • monitoring the participants after the administration of cannabis
      • specifying the time period that participants need to stay at the study site after consuming cannabis
      • providing a secure mode of transportation to get to their destination after consuming cannabis
      • providing a contact number to participants in case they experience an adverse event while they are in transit or after they arrive at their destination (for example, the licence holder may escort participants to their destination or pay for a taxi or ride sharing, participants shouldn't drive, use public transit or otherwise actively transport themselves)
  • Data handling and record keeping, including:
    • the type of information (for example, adverse event information, cannabis information, study-related documents) that will be recorded and stored
    • the duration of record keeping to meet the requirements of the Cannabis Regulations
    • the steps that will be in place to secure all documents for long-term record keeping   
  • Ethics, including:
    • how access to study data and documents will be secured to:
      • maintain participant confidentiality
      • protect privacy
      • prevent unauthorized access to the data
    • a description of anyone who may have access to the records (for example, study personnel, Health Canada)
    • a description of the informed consent process for the study
    • other considerations (if applicable) including:
      • information on the use of the study findings
      • any real, perceived and potential conflicts of interest
  • References, including:
    • all publications referenced in the text of the protocol using a consistent and standard format
  • Appendix: Study questionnaire, including:
    • a copy of the questionnaire to be used in the study
Full protocol

You're encouraged to use the Full protocol template when submitting a research licence application to conduct a Category 2 or 3 NTRC study. The requirements of the full protocol are based on the applicable requirements for protocols outlined in section 6 of the International Council for Harmonisation E6: Guideline for Good Clinical Practice (ICH E6).

The following information needs to be included in the full protocol:

  • Background and rationale of the study, including:
    • an explanation of the context and importance of conducting this study
    • a summary of previous relevant research
    • any history of human use of the cannabis or other relevant evidence (for example, preclinical studies) to support the safety and objective(s) of the current study
  • Study objective(s), including:
    • a clear statement of the study objective(s)
  • Study design and duration, including:
    • the study design:
      • key details on the study methods such as randomization, parallel, cross-over, blinding and any controls or comparative agents, if applicable
      • aspects such as fasted or non-fasted state(s), particularly for pharmacokinetics, and data collection methods (for example, questionnaire, biomedical data collection at baseline and throughout the study and their intended purpose)
      • any washout period(s) and rationale for selecting the length of the washout period(s) if more than one cannabis item or placebo are administered to the participants
      • the number of study site(s) (single or multiple sites)
    • the study duration:
      • the overall study duration (anticipated starting date and study completion)
      • the duration of study for each participant, from screening and enrollment to final follow-up
  • Description of cannabis, including:
    • the licence holder's name
    • the identifier or brand name (if applicable)
    • the cannabis class (for example, dried cannabis, fresh cannabis, cannabis extract)
    • the cannabis form (for example, pre-rolled joint, capsule, spray)
    • the net weight or volume of cannabis in the container
    • the net weight and number of discrete units per immediate container, if applicable
    • the name and quantity of the cannabinoid(s) (mg/g or mg/unit)
    • the ingredients
    • a description of the accessory that contains cannabis, if applicable
    • sensory attributes of the cannabis (such as the flavour, scent, colour and shape)
    • additional information on the cannabis, including anything that significantly distinguishes the cannabis (for example, nano- or biotechnology based, re-introduced terpenes)
    • description of the processing activities with the cannabis (if applicable)
  • Amount, frequency and mode of consumption of the cannabis, including:
    • the amount(s) of cannabis per administration to a participant
    • the frequency of administration (including if multiple different frequencies are planned)
    • the mode(s) of consumption (for example, smoking, vaping, ingesting)
  • Study participants, including:
    • the method for recruiting participants
    • the total number of participants and study groups and number of participants in each group
    • the inclusion criteria (for example, age bracket, pattern or frequency of cannabis use, health status, specific clinical or psychological diagnosis and symptom(s), past and current medical treatment, use of appropriate contraception)
    • the exclusion criteria (for example, pre-existing medical or psychological conditions, concomitant use of certain health products including medication(s) or natural health products)
  • Study procedures, including:
    • a description of all study procedures, measures and assessments to fulfill the objectives of the study as well as to protect the health and safety of study participants
    • a description of the pre-study screening and baseline evaluation a description of all visits and the procedures performed at each visit, including any close-out or end-of-study visits
  • Measured effects, including:
    • the method(s) to collect data on the measured effects (for example, questionnaire, collection of biological specimens including volume and frequency, collection of physical measurements, or imaging assessments)
    • the justification of why the measured effects support the objective(s) of the study (for example, repetitive blood draws are used to study the onset of the intoxicating effects of THC after ingestion or inhalation of cannabis containing the same amount(s) of THC)
  • Safety monitoring plan and procedures, including:
    • how adverse events will be monitored, recorded and assessed and the proposed strategy to mitigate the risks of adverse events
    • how serious adverse reactions will be reported as per the requirements in section 248.2 of the Cannabis Regulations
    • the criteria and procedures for withdrawing participants from the study
    • the procedures for making sure that participants receive proper medical attention after an adverse event if and when necessary
    • how participants will be followed up with after being withdrawn from the study due to adverse reactions
    • how you will ensure participants safety throughout the study, including:
      • monitoring the participants after the last administration of cannabis
      • specifying the time period that participants need to stay at the study site
      • providing a secure mode of transportation to get to their destination after consuming the cannabis (for example, the licence holder may escort participants to their destination or pay for a taxi or ride sharing. Participants need to not drive, use public transit or otherwise actively transport themselves)
      • providing a contact number to participants in case they experience an adverse event while they are in transit or after they arrive at their destination
  • Premature withdrawal or discontinuation criteria, including:
    • a statement that participants may withdraw voluntarily from the study at any time or that they may be removed from the study
    • a discussion of how participants who withdraw or are removed early from the study will be replaced, if relevant to the study. This section may not be applicable to some studies (such as studies involving a single visit or measuring a single time point).
  • Statistical considerations, including:
    • a description of the statistical methods to be used and level of significance to be used
    • the number of participants (sample size) to be enrolled
    • the methods of statistical analysis (for example, multiple regression, repeated measures mixed models, analysis of variance (ANOVA))
    • a procedure for accounting for missing, unused and spurious data
    • study hypotheses including the null and alternative hypotheses for the measured effects, specifying the type of analysis and time period for analysis for each measured effect
    • sample size determination, providing the rationale and calculations for determining the sample size and anticipated drop-out rate
    • types of analyses to be performed:
      • intention-to-treat (ITT) analysis (includes all randomized participants)
      • per-protocol (PP) analysis (includes only participants who complied with the protocol)
    • statistical outcomes:
      • the statistical procedure(s) that will be used to analyze the measured effects
  • Quality assurance and quality control, including:
    • a plan for quality management, encompassing quality assurance (QA) and quality control (QC) such as:
      • how data, biological specimens and other medical tests, when applicable, will be evaluated for compliance with the protocol
      • any ethical standards that will be used
      • staff training records and procedures in place for assurance of staff reliability
  • Data handling and record keeping, including:
    • the type of information (for example, adverse event information, cannabis information, study-related documents) that will be recorded and stored
    • the duration of record keeping to meet the requirements of the Cannabis Regulations
    • the steps that will be in place to secure all the documents for long-term record keeping   
  • Ethics, including:
    • how access to study data and documents will be secured to:
      • maintain participant confidentiality
      • protect privacy
      • prevent unauthorized access to the data
    • a description of anyone who may have access to the study documents (for example, study personnel, Health Canada)
    • a description of the relevant informed consent process for the study
    • other applicable considerations including:
      • information of the use of the research findings
      • any real, perceived and potential conflicts of interest
  • Additional considerations, including:
    • a description of any additional considerations not currently covered in the protocol, such as local regulatory or additional REB-related requirements, if any. If there are no additional considerations, indicate "N/A"
  • References, including:
    • all publications referenced in the text of the protocol using a consistent and standard format
Cannabis research and evidence dossier

You're encouraged to use the Cannabis research and evidence dossier (CRED) template when submitting a research licence application to conduct a Category 2 or 3 NTRC study. The CRED is a document that should provide information from the most recent available evidence (for example, from the literature or from studies performed by the applicants) relevant to the cannabis being studied (for example, the particular cannabinoid(s) being studied, the amount(s) and mode(s) of consumption). Where possible, providing information about the cannabis within the context of the participant population is preferable. While the CRED doesn't need to be specific to the cannabis used in the study, if information specific to it exists, then that is preferable. Additional information on the contents of the CRED along with recommended sources of evidence can be found on the Additional information to conduct non-therapeutic research on cannabis web page.

The following information needs to be included in the CRED:

  • Summary, including:
    • a brief summary (1-2 pages maximum) of the information and evidence contained in the CRED
    • highlights of the key relevant physical, chemical, clinical and pre-clinical information on the cannabis
    • where no human data are available, a justification for using pre-clinical data should be highlighted
  • Physical and chemical properties and formulation of cannabis, including:
    • a description of a discrete unit of the cannabis (for example, capsule, spray, joint)
    • the net weight or volume of the cannabis, as well as the number of discrete units per container or package, where applicable
    • the concentrations of cannabinoid(s) and all other known substances (for example, terpenes) per discrete unit of the cannabis (for example, 10 mg THC per unit), where applicable 
    • the Chemical Abstracts Service (CAS) number(s) of the cannabinoid(s) and other substances (for example, terpenes) to be studied, where applicable
    • the list of ingredients(s) as well as any feature(s) that significantly distinguishes the cannabis from cannabis products with established histories of use (for example, dried, oil, traditional concentrates such as hash) or makes it novel (for example, nano-formulations), where applicable
    • any information on the cannabis accessory (for example, quantity of cannabis delivered per activation), where applicable
    • instructions for the storage, handling and preparation of the cannabis prior to administration
  • Summary of clinical data, including:
    • a summary of available pharmacokinetics (PK), pharmacodynamics (PD), safety and drug interactions data taken from the most recent version of the Information for Health Care Professionals: Cannabis and the cannabinoids (IHCP) and from other recent and relevant sources
    • the data doesn't have to be specific to the cannabis used in the study, but you're encouraged to provide it if it's available. The information needs to be relevant to:
      • the cannabis class (for example, dried or edible cannabis) and form (for example, pre-rolled joint, capsule, spray)
      • the mode(s) of consumption
      • the cannabinoid(s) and any other substances (for example, terpenes) being studied 
      • the amount(s) of cannabinoid(s) being administered 
      • the frequency and duration of administration (such as when there's a repeated exposure) 
      • the study participants (for example, healthy adults, older adults, adults with chronic diseases, adults already taking certain medications or other health products) any other considerations that may be applicable
      • any specific aspects of the study design (for example, co-exposure with other substances, such as ethyl alcohol and nicotine), if applicable 
    • an explanation of how the evidence provided for each subsection supports:
      • the study design
      • the safety of the cannabis
      • the study objectives
    • a scientific rationale to explain any differences in the available evidence and the specific cannabis used in the study
    • primary references from the IHCP need to be provided in addition to other supporting literature
    • a brief rationale needs to be provided if a subsection is not relevant (for example, "IHCP doesn't contain pharmacokinetic data on the proposed mode of administration and no additional relevant evidence is found in the published literature")
    • lack of safety data in humans needs to be indicated
  • Summary of pre-clinical safety data, including:

    Important: This section is only required when there is no sufficient human safety data available.

    • a summary of available (published or unpublished) toxicology data from single-dose or repeated-dose studies in animal models:
      • a brief description of the animal model(s) used
      • the tests conducted
      • the results obtained and their meaning in the context of the study
      • how the data are relevant to the proposed study
      • how the data support the safe use of the cannabinoid(s) and any other substance(s), if applicable, in humans
    • the data needs to be relevant to the cannabinoid(s) and any other substance(s), if applicable, being studied
    • repeated-dose animal studies may not be required if the NTRC study only requires a single administration of cannabis. If this is the case, it should be indicated that it's not applicable with a brief justification.
    • if available, PK and PD studies and other pre-clinical testing (for example, carcinogenicity, reproductive toxicity, genotoxicity) may be provided
  • Overall synthesis and summary of evidence and risk management, including:
    • a summary of the available safety information (clinical and non-clinical data, as well as adverse reaction data) at the amount(s) of cannabis to be used in the NTRC study
    • where no sufficient human safety data are available, scientific rationale or extrapolation of the available information from animal models (including assumptions) needs to be provided to show the safety of the cannabis at the amount(s) recommended in the protocol
    • information on the risks associated with the use of the cannabis, including specific laboratory tests (such as a liver function test), safety monitoring and precautions that may be needed for the study
    • known and potential risks and adverse reactions associated with the use of the cannabis
  • References, including:
    • all publications referenced in the text of the CRED using a consistent and standard format

2.10 Other research sites

If your proposed research activities need to occur at multiple sites (such as processing or extraction of cannabis, clinical trial conducted at multiple hospitals), you need to provide the address of each additional site. The address of each additional authorized site will appear on the licence, if a licence is granted. For each site, you need to indicate if you intend to cultivate, synthesize, produce cannabis or sell cannabis plants or seeds as well as the type of research.

Important: A project-based research licence application that includes multiple protocols and multiple sites is not an acceptable research model. If you have different protocols for different activities occurring at multiple sites, you should submit a research licence application for each site or protocol.

An IRL may cover a campus or multiple buildings within a geographic area. If you're seeking an IRL, within your Physical security measures framework document, you need to provide a list of the names (if available) and addresses of each building associated with the institution's site. The address of each building associated with the institution's site will appear on the licence, if a licence is granted.

Important: The responsible person of the IRL will be responsible for all the activities conducted at the institution's site.

2.11 Research protocol

Project-based research licence applications

Important: If you're applying for a project-based research licence to conduct activities in relation to NTRC, you need to upload a blank document in the "Research Protocol" section of the CTLS. All application documents for NTRC need to be uploaded in the in the "Non-Therapeutic Research on Cannabis Protocol" section.

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. You're encouraged to use the Research protocol for project-based research licence applications template.

The following needs to be included in your research protocol:

Tip: You don't need to submit a full research grant proposal or an animal care or Clinical trial application. Only the research protocol document is required.

Institution-wide research licence applications

Important: You need to complete this section if you're seeking an IRL, for all research types, including research activities in relation to NTRC. If you're applying to conduct activities in relation to NTRC as an IRL, include the protocol title in your research project administration framework.

An IRL covers multiple research projects at the same institution such as multiple projects within a university campus. If you're seeking an IRL, you need to provide a Research project administration framework document that describes the institution's framework for managing the institution's cannabis research program. You are encouraged to use the Research protocol for IRL applications template.

For IRL applications, the following is a list of required information to provide in your institution-wide research project framework as a single document:

Additional documents for in vivo studies

If you intend on conducting in vivo studies with cannabis, you may be required to obtain an Experimental studies certificate (ESC). Examples of when an ESC is required include research conducted in a food producing animal (such as dairy cattle, fish, bees) or trials intended to support the future authorization of a product for use in animals (such as a veterinary drug submission). If an ESC is required, you need to:

For additional information animal study authorizations, refer to the Experimental Studies Certificate Application Form or contact the Veterinary Drugs Directorate at hc.vdd.skmd.so-dgps.dmv.cp.sc@hc-sc.gc.ca.

Additional documents for NTRC

For each NTRC research study you intend on conducting, you'll need to submit all required NTRC documents for the applicable risk category. These documents are submitted in addition to your research project administration framework.

Additional documents for clinical trials (not NTRC)

If you intend on conducting clinical trials with cannabis using human research subjects, you should obtain a No objection letter (NOL) for a clinical trial. You may file your clinical trial application with Health Canada before or after you file your research licence application. Your clinical trial may not start before you obtain a research licence and an NOL. Additional information on clinical trial application requirements can be found in the Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications. For more information regarding clinical trial authorizations, contact the Office of Clinical Trials at hc.oct.enquiries-requetes.bec.sc@hc-sc.gc.ca. 

Organization chart for institution-wide research licence application

You need to prepare an organization chart containing the management structure and reporting relationships if you're applying for an IRL. It should include:

The chart needs to include each person's:

If you're a corporation applying for an IRL, you may submit your corporate organization chart. You need to ensure that the responsible person and the alternate responsible person, if applicable, are listed.

3.0 Physical Security

As per section 77 of the Cannabis Regulations, a holder of a licence for research must ensure that operations areas at the site set out in the licence are designed in a manner that prevents unauthorized access.

The operation areas where authorized activities are proposed to take place need to be designed to prevent unauthorized access. You need to have a site plan and a physical security plan that demonstrates how the operation areas and storage areas are designed in that way. There's different physical security information required for a project-based research licence and an IRL.

Tip: If you already have a cannabis licence at your site, such as a standard cultivation, processing or medical sales licence, your physical security plan needs to include information on how you'll keep the authorized activities and record keeping under each licence separately.

3.1 Project-based research licences

Site plan

Important: Your site plan needs to include all areas and rooms, even if there are no activities with cannabis occurring inside. For example, lavatories and transitory areas such as hallways.

You need to include the following information in your site plan. You need to have at least 1 building on your site when you submit your licence application. If you can't put all the information onto 1 site plan, you can also add floor plans to your document.

Physical security plan

Regardless of the quantity of cannabis to be stored on site, a physical security plan must be provided to Health Canada. The physical security plan needs to demonstrate how you will meet section 77 of the Cannabis Regulations, based on risk factors specific to your site (for example, amount of cannabis on site, potential risks for diversion). The physical security plan needs to describe how the operations areas and storage areas of your proposed site are designed to prevent unauthorized access, and how access to the operations and storage area(s) are restricted to individuals whose presence in the area is required by their duties. You need to include the following details:

If Health Canada determines that your site presents a higher risk, you may be asked to implement stronger security measures. You may wish to familiarize yourself with the Physical security measures guide for security measures that may be recommended in instances of very large quantities of cannabis or greater security risks.

Tip: If you're a holder of a licence for cultivation or processing for the same site, and the same security measures will be applied to the research licence for which you have applied, a copy of your Organizational security plan (OSP) is considered acceptable. If there are any changes to your site that is different from the OSP, you need to submit a new physical security plan that is specific to your research licence application.

3.2 Institution-wide research licences

An IRL allows a licence holder to conduct research in accordance with a physical security measures framework reviewed by Health Canada at a site, which could include multiple rooms within a building or multiple buildings within one geographic area.

Tip: If you're applying for an IRL, a physical security measures framework needs to be submitted in a single document. If you know where the operations and storage areas will be located, include a site plan including these areas in a separate document.

Site plan

Your site plan needs to include all authorized buildings where operations and storage areas will be located. This includes areas where there are no activities with cannabis occurring (for example, lavatories and transitory areas such as hallways).

For operations and storage areas, you need to include the following information:

Important: You need to provide a site plan only if you know the operations and storage areas that you'll be conducting cannabis research activities in. If you don't know the location of these areas when you submit your IRL application, you can submit your site plan after your IRL has been issued through a licence change application.

Physical security measures framework

You need to provide a Physical security measures framework document for your proposed site. The physical security measures framework must demonstrate how you will meet section 77 of the Cannabis Regulations, based on risk factors specific to your site (for example, amount of cannabis on site, potential risks for diversion). The physical security measures framework needs to include:

The physical security measures subsection of the physical security measures framework should include:

The institution's and the institution's responsible person's oversight of the physical security measures subsection of the physical security measures framework should include:

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 is assessed on a case-by-case basis.

4.0 Identified people

As part of the application, you'll need to identify the people that will fill the roles of responsible person, and the alternate, if applicable.

There are no security clearance requirements for personnel under a research licence. Your identified people cannot apply for a cannabis security clearance for other cannabis licences through your research licence application.

4.1 Responsible person

The responsible person needs to create an account in the CTLS, if they don't have one already. Submit the following information on your responsible person:

4.2 Alternate responsible person

The alternate responsible person needs to create an account in the CTLS, if they don't have one already. You'll need to submit the following information for your alternate responsible person:

4.3 Consent to communicate

You need to gather the CTLS Account IDs of the people who will be authorized to communicate with Health Canada (consent to communicate).

5.0 Record keeping

Copy of government-issued identification

In order to verify the identity of the responsible person, or alternate responsible person, if applicable, you need to provide a copy of government-issued identification. Examples of acceptable identification are:

See the Government of Canada Guidance on acceptable valid identification.

Record keeping attestation form

You need to sign a Record keeping attestation. The responsible person and the alternate responsible person need to sign their own attestations.

Important: Note that the record retention period for research licences authorized to conduct research activities in relation to NTRC is two years after the date on which the research ends.

Responsible person attestation (for institution-wide research applicants only)

A senior member of the institution's administration (such as president, chancellor, vice president or equivalent) needs to sign an attestation that the institution's responsible person:

Refer to the Institution-wide research licence responsible person attestation. A senior member of the institution's administration also needs to provide an attestation for the alternate responsible person.

Site attestation (For institution-wide research applicants only)

The responsible person needs to attest that the proposed site under the IRL is limited to the buildings identified in the application where research activities will occur and doesn't include any areas that are not under the licence holder's exclusive use such as, but not limited to:

Refer to the Institution-wide research licence site attestation. The responsible person and the alternate responsible person needs to sign their own attestations.

Important: There's no specific section in the current version of the CTLS to upload this information. It should be uploaded as an attachment under the "Record Keeping Description" section.

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