Application requirements for cannabis research licences

Organization: Health Canada

Published: 2019-09-06

Cannabis Licensing Application Guide: Research

Application Requirements and Process to Become a Research Licence Holder under the Cannabis Act and Cannabis Regulations

Table of Contents

• Foreword
• Purpose
• Background
• Scope
• Getting started: the application process
• Step 1: Confirm the need for a research licence and determine appropriate licence model
  • Is a licence required?
  • Determine licence model
• Step 2: Create an account in the Cannabis Tracking and Licensing System (CTLS)
  • Creating an individual account in the CTLS
  • Creating a corporate profile
• Step 3: Develop your application
  • I. Licence ownership (licence holder)
  • II. Mailing address
  • III. Site details (which includes details on the proposed research activities)
  • IV. Site personnel
  • V. Physical security
  • VI. Record Keeping
• Step 4 - Submit your application
  • Submitting your application
  • Following submission
  • Service Standards
  • Administrative procedures
• Contact us
• Feedback - Help us improve
• Appendix A: Sales questionnaire
• Appendix B: Research protocol for project-based applications (single or multiple sites) (suggested template)
• Appendix C: Research protocol for institution-wide applications for multiple projects at a single site (suggested template)
• Appendix D: Equivalent amounts
• Appendix E: Physical security plan (suggested template)
• Appendix F: Record keeping attestation
• Appendix G: Submission checklist

Purpose

This document provides information on the application requirements to obtain a licence for research from Health Canada under the Cannabis Act and Cannabis Regulations.

Background

The Cannabis Act and its Regulations provide, among other things, the framework for legal access to cannabis and control and regulate its production, distribution and sale. Under this framework, a person is required to obtain a licence issued by Health Canada in order to conduct various activities with cannabis, including research. Applicants and Licence Holders are responsible for compliance with the Cannabis Act and its Regulations as well as compliance with other applicable federal, provincial and territorial legislation and municipal by-laws.

The Cannabis Act establishes that an application for a licence must be submitted to Health Canada in the form and manner specified by the Minister^{Footnote 1} and must include the information required by the Minister. This guide sets out the application process including the form and manner for submitting an application for a research licence and the information that is required.

Health Canada publishes other guidance documents and information on its website that may be used in conjunction with this document to assist you in preparing your application. In order to maintain consistency and transparency, this guide, as well as other guidance documents and information, will be updated, as required, to reflect changes to policies and/or operations.

Scope

This document provides guidance to anyone wishing to apply for a licence under the Cannabis Act and Cannabis Regulations to conduct activities in relation to research involving cannabis.

For more information on requirements associated with the activities that are not addressed in this guide, applicants may refer to the Cannabis Act and Cannabis Regulations, additional guidance published on the Health Canada website or contact Health Canada as outlined at the end of this guide.

This guide does not include information on additional licensing requirements that may be required by the Canada Revenue Agency or provinces and territories.

Health Canada has established an online licence application system, referred to as the Cannabis Tracking and Licensing System (CTLS), to be used by applicants to apply to Health Canada for a cannabis licence. Applicants should be familiar with the use of this system and should refer to the CTLS User Guide for more information, available upon request from cannabis@canada.ca.

Getting started: the application process

This guide is separated into four steps to help you navigate the application process. The process flow outlined in Figure 1 provides a general summary, with references to the relevant parts of this guide.

Figure 1: Application process

Step 1: Confirm the need for a research licence and determine appropriate licence model
Step 2: Create an account in the Cannabis Tracking and Licensing System
Step 3: Develop your application
Step 4: Submit your application

Step 1: Confirm the need for a research licence and determine appropriate licence model

Is a licence required?

Before applying for a licence, first determine whether a research licence is the appropriate licence for your proposed activities. Research activities can include, but are not limited to, in vivo and in vitro studies, clinical trials, plant genetics, cannabis product development, 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.

Determine 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:

1. One project, one site: One research licence covering one research project, generally with a single research protocol and activities taking place at only one site. If you are a research group that has more than one project, but all under the purview of a single principle investigator in one research area, this model would still apply.
2. One project, multiple sites: One research licence covering one research project, but with research activities taking place at multiple sites (e.g., a clinical trial at numerous hospitals).
3. One institution, one site: One research licence covering multiple research projects taking place at one institution (e.g., numerous researchers or projects at a single university campus or research hospital; or a large research group performing multiple projects, such as a contract research organization).

Determine what model best suits your proposed research activities prior to starting your application, as 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 hc.sp-licensing-cannabis-licences-sp.sc@canada.ca for clarity and to help ensure an appropriate application pathway is developed.

Step 2: Create an account in the Cannabis Tracking and Licensing System (CTLS)

Health Canada's Cannabis Tracking and Licensing System, or CTLS, is a public facing web application that enables the submission of new licence applications, requests for amendments, and licence renewals in addition to the submission of monthly tracking reports for those Licence Holders required to submit them.

Creating an individual account in the CTLS

In order to submit a licence application in the CTLS, you must first request access. In order to do so, basic information is required including your full name and salutation, email, phone number, date of birth, language preference and security information. Health Canada will then provide an Account ID that can be used to enter the CTLS. You can use the same Account ID for each licence application to which you may be associated.

For more information on the steps to create an account please refer to the CTLS Getting Started Guide.

Create accounts in the CTLS for individuals associated with the application. User accounts are also required for additional individuals associated with a research licence application (see Table 1). These individuals must create their own accounts in the CTLS before an application can be completed and submitted to Health Canada.

Creating a corporate profile

An application for a research licence can be created for an individual, an academic institution/research centre, or a corporation. Only applicants that are corporations must ensure that a corporate profile for the organization has been created in the CTLS. Incorporated academic institutions are exempt from having to create a corporate profile.

In order to create a corporate profile, individuals associated with the corporation (i.e. directors and officers) must create user accounts and those Account IDs must be linked to the corporate profile. Once the corporate profile has been created, a new Corporation ID is created for the corporation. This Corporation ID can then be used to create the research licence application, where the corporation can be specified as the Licence Holder.

Creating a corporate profile has some additional requirements, as outlined in Table 2. Some requirements are needed to create a corporate profile in the CTLS, while others are required before an application is submitted.

Step 3: Develop your application

Once you have the appropriate Access IDs to the CTLS, and have determined which licence model you will use, you are ready to start developing your application. There are six main sections of a research licence application:

1. Licence ownership (Licence Holder)
2. Mailing address
3. Site details (including research activities)
4. Site personnel
5. Physical security
6. Record keeping

Each of these sections must be complete prior to submitting an application to Health Canada. If your application does not fulfill all of these requirements Health Canada may refuse to consider your application.

I. Licence ownership (licence holder)

In this section of the application, you are required to identify the Licence Holder. An application can be created for an individual, an academic institution/research centre, or a corporation. If you apply as a corporation, you must ensure that you have completed a corporate profile for the organization in the CTLS as outlined in Step 2.

Further, a Responsible Person must be designated for all applications. The Responsible Person has the authority to bind the Licence Holder, has overall responsibility for the activities conducted, and is responsible for submitting the application. The Responsible Person is the official point of contact with Health Canada.

II. Mailing address

This section of the application allows you to enter a mailing address identifying a Canadian address where you would like to receive official mailed correspondence (e.g., the licence when issued).

III. Site details (which includes details on the proposed research activities)

This section of the application seeks information about the site(s) where the proposed research will be undertaken, as well as information on proposed research activities. Table 3 outlines the Site Detail requirements that must be provided as part of a research licence application.

IV. Site personnel

As an applicant for a research licence, you do not have to provide information in the "site personnel" section in the CTLS.

However, keep in mind that, as outlined in Step 2, you do need to identify the individuals that must have CTLS accounts and these individuals will need to create CTLS accounts and provide their Account IDs to you, as the licence applicant (e.g. if applying as a corporation it is necessary to identify directors and officers). Please refer to Table 1 for details.

V. Physical security

All applications must have a plan for how the operations areas where research activities are proposed to take place are designed in a manner that prevents unauthorized access.

For project-based applications, when quantities of cannabis exceed a total of 1 kg and the applicant is not already a Licence Holder for the cultivation or processing of cannabis, a description of the plan must be provided to Health Canada. This must include a brief description of the site, including its perimeter and the physical security plan for operational and storage areas as well as a brief description of who would have access to operations areas, how access would be controlled to operations area(s), and how storage of the cannabis would be secured.

If the total maximum quantity of cannabis at a site exceeds 11 kg equivalent of dried cannabis, please also include a site plan including clear identification of the perimeter and the delineation of storage and operational areas.

For applicants seeking an institution-wide research licence that would cover multiple research projects at the same site (e.g. multiple projects within a single university campus), a clear framework must be provided to demonstrate how the Responsible Person will ensure that storage and operations areas where any research activities are proposed to take place are designed in a manner that prevents unauthorized access, that security measures are appropriate to the various activities taking place across the institution and that measures are in place to mitigate risk based on the quantities of cannabis present where cannabis research activities will take place within their institution or campus. For example, this may be provided in physical security and record-keeping SOPs that researchers conducting activities under the institution-wide licence must follow to ensure compliance with section 77 of the Cannabis Regulations, or a description of other compliance monitoring mechanisms that will be put in place.

Table 4 provides a summary of the information that demonstrates how physical security requirements would be met.

VI. Record Keeping

There are a number of regulatory requirements for record keeping that must be met by a Licence Holder. Table 5 provides a summary of the information that must be submitted as part of a research licence application. The Record Keeping Attestation is found in Appendix F and provides additional details about record keeping requirements for applicants for a research licence.

Step 4 - Submit your application

Submitting your application

Once all required information has been entered/uploaded in the CTLS, the application is ready to be submitted.

Use the checklist in Appendix G to ensure that all required pieces have been completed and are included in your submission. Once an application is submitted, no further changes can be made.

Once the application is submitted, it will appear in the "Submitted Licence Applications" section of the CTLS. Each application will have a unique Licence Application ID. All correspondence with Health Canada in relation to the application should include this identifier in the subject title.

Following submission

Once an application is submitted in the CTLS, there are a series of steps Health Canada undertakes to review the licence and take a decision. A risk-based approach is used to triage applications, depending on a variety of factors such as the maximum quantity of cannabis proposed at the site, or whether multiple projects are part of the application.

Applicants are encouraged to check the status of their application using the CTLS at any time during the application process. Table 6 below provides an explanation of the four categories in the CTLS that denote the status of the application..

Service Standards

Health Canada commits to a non-binding 42 business day service standard for single project applications and up to 180 business days for multiple project or institution-wide applications; these align with service standards that previously existed under the Narcotic Control Regulations for s. 56 exemptions or for research with cannabis, respectively.

Administrative procedures

Receiving and responding to a request for more information

Under subsection 62(5) of the Cannabis Act, Health Canada may request the submission of any additional information pertaining to an application.

It is the applicant's responsibility to meet all the licensing requirements. If information submitted as part of the application is unclear or requires further detail to show how it meets the requirements, Health Canada will ask the applicant for clarification through a request for more information (RMI). To avoid such a request, ensure your application includes the details noted in this guide and addresses all items in the checklist included in Appendix G.

When an RMI is sent, Health Canada strives to be clear about what information is needed from the applicant and a deadline to respond is provided. If the applicant is unclear about what is required to respond to the request for more information, they may contact Health Canada by email for further guidance (see Contact Information Section of this guide). Note that it is not a requirement to retain the services of a third party (e.g., consultant) to prepare responses to Health Canada.

A request for more information will be emailed to the Responsible Person. The applicant must respond by email within the timeframe requested. Responses should be comprehensive and comment on each of the elements noted in the request for more information. A revised version of the original documents should not be resubmitted unless requested to do so.

Refusals and withdrawals

Health Canada may refuse to issue a research licence under circumstances set out in the Cannabis Act and its Regulations. These include:

• Issuing the licence is likely to create a risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity;
• There are reasonable grounds to believe that false or misleading information or false or falsified documents were submitted in, or in support of, the application;
• Within the last 10 years the applicant has contravened a provision of the Cannabis Act, the Controlled Drugs and Substances Act or the Food and Drugs Act or of any regulation made under any of those Acts;
• Within the last 10 years there are reasonable grounds to believe that the applicant has contravened an order or a condition of a licence or permit under the above-noted Acts;
• The applicant is a young person (as defined in the Cannabis Act), an individual who does not ordinarily reside in Canada, or is an organization that was incorporated, formed or otherwise organized outside Canada;
• The Minister is of the opinion that it is in the public interest to do so;
• Any prescribed grounds for refusal exist.

In the cases mentioned above, Health Canada may send a Notice of Intent to Refuse. This Notice will provide the applicant with a timeframe within which to respond, after which a Notice of Refusal will be issued.

The Notice of Refusal sets out the specific reasons or deficiencies that resulted in the decision to refuse to consider the application or issue a licence. All decisions to refuse an application are without prejudice to filing a new application for a licence. If an applicant wishes to submit a new application at a future time, it will be processed as such. Information and data submitted to support an application will not be returned to the applicant.

At any time during the review of an application, the applicant may withdraw the application through the CTLS. Withdrawal of an application is without prejudice to re-filing the application. If an applicant wishes to resubmit an application at a future time, the application will be processed as a new application.

Changes to an application/unsolicited information

Once an application is submitted, changes cannot be made to the application within the CTLS. If a change is required, the applicant must contact: hc.sp-licensing-cannabis-licences-sp.sc@canada.ca. The email must clearly indicate the application file number, the applicant's name and the subject of the correspondence in the subject line of the email.

Contact us

For questions related to a specific licence application, an email may be sent to: hc.sp-licensing-cannabis-licences-sp.sc@canada.ca. The email must clearly indicate the application file number, the applicant's name and the subject of the correspondence in the subject line of the email. Meeting or teleconference requests are evaluated on a case-by-case basis.

For other general questions about the Cannabis Act and its Regulations outside of a specific application, including those related to the CTLS, email: cannabis@canada.ca.

Alternatively, the Controlled Substances and Cannabis Branch may be contacted by phone at
1-866-337-7705.

Feedback - Help us improve

Health Canada is committed to providing all stakeholders with timely, accurate and reliable information. This includes providing applicants and Licence Holders with the information they require in order to be compliant with the Cannabis Act and its Regulations.

Health Canada appreciates receiving your feedback on whether this guide was useful and would welcome your suggestions for improvement. Please send us your feedback by email to: cannabis@canada.ca and indicate in the subject line: "Feedback on Research Application Guide".

Your feedback will help us improve this guide and better serve all applicants and Licence Holders.

Appendix A: Sales questionnaire

Download PDF (1 page, 96 KB)

Questionnaire regarding activity of sale for research licence holders/applicants

For applicants seeking authorization to sell plants, seeds, or other physical products of research with cannabis, Health Canada requires certain information in order to maintain oversight on what is intended to be sold and ensure that sales stemming from commercialization of research are limited in nature and consistent with the objectives of the Cannabis Act and its Regulations.

As part of our review of your request to have the activity of sale added to your research licence, we ask you to complete the following questionnaire:

• Who do you intend to sell to? Be as specific as possible.
  [Example: to a holder of a licence for research (insert licence number)]
• What do you intend to sell (cannabis plants and/or cannabis seeds)?
  [Example: tissue cultures, cannabis cuttings for clonal propagation]
• What quantity of cannabis do you intend to sell (e.g., number of plants and/or cannabis seeds)?
  [Example: 10 plants]
• Is this a one-time sale, or do you intend to make repeated sales of the same or similar products of cannabis research to the same Licence Holder? If repeated sales, include rationale and anticipated frequency of this transaction.
  [Example: repeated sales (insert rationale), 4x per year]
• What is the expected value of the cannabis that you intend to sell (e.g., dollar value per cannabis plant and/or cannabis plant seed)?
  [Example: $100/plant]
• When do you intend to make the sale(s)?
  [Example: month and year]
• Why are you intending to sell the cannabis?
  [Examples: for further research, to commercialize the outcome of research]
• What does the buyer intend to do with the cannabis (if known)?
  [Example: propagation of new genetics]

Appendix B: Research protocol for project-based applications (single or multiple site) (suggested template)

Download PDF (1 page, 155 KB)

• Protocol title
• Outline
  • Please include a brief summary of the field of research and the tools used to perform said research with cannabis (e.g., analytical techniques, specify any in vivo or in vitro models to be used). If human subjects are involved with this research, please explicitly state the nature of their involvement
• Is there more than one site for the proposed research? Provide details.
• What is the maximum quantity of dried cannabis that will be possessed at all sites at any given time?
  • If the quantity of cannabis exceeds 1 kg of dried cannabis or equivalent at any one site and there is no existing cultivation or processing licence at the site, please be sure to include a physical security description with the application. If the quantity exceeds 11 kg of dried cannabis or equivalent at any one site and there is no existing cultivation or processing licence at the site, please be sure to include a site plan with the application.
• What is the duration sought (in years) for the licence application? Please provide a rationale.
  • A research licence may be effective for the duration of the research project, up to a maximum of five years. If the research project needs to continue past the expiry date of the licence, the licence holder may apply for a renewal of the licence.
• Do you attest that the source of cannabis is from a legal supplier?
  • Suppliers may be a licensed cultivator or processor or a legal foreign source, but not holders of an analytical testing licence. A legal source also does not include individuals, including those formerly registered under prior regulations or currently registered under the Cannabis Regulations.

Yes, I attest that the source of cannabis will be from a legal source.

Appendix C: Research protocol for institution-wide applications for multiple projects at a single site (suggested template)

Download PDF (1 page, 116 KB)

• Nature of research performed at the institution
  • Please include a brief summary of the various proposed research programs and tools used to perform said research (e.g., identify the principal investigators and their field of research, including any potential in vivo model organisms). If human subjects are to be involved with any research, please outline the scope and nature of any anticipated projects.
• What is the estimated maximum quantity of dried cannabis (or non-dried equivalent - equivalent amounts can be found in Appendix D) that will be possessed at any given time?
  • The estimated maximum quantity of cannabis that is proposed to be possessed or produced by the applicant at any given time (e.g., kilogram, litre or number of plants or seeds, as appropriate). The square footage of grow area would also be acceptable if number of plants is not feasible.
• A brief description of institutional frameworks and their involvement to ensure oversight and/or coordination of the various research projects that will be conducted with cannabis at the institution, and adherence to the Cannabis Act and its Regulations as well as other regulations that may govern activities performed with cannabis.
  • e.g., cannabis research office, animal care committees, research ethics boards, campus security services, etc.
• What is the duration sought (in years) of the licence application? Please provide a rationale.
  • A research licence may be effective for the duration of the research project, up to a maximum of five years. If the research project needs to continue past the expiry date of the licence, the licence holder may apply for a renewal of the licence.
• Do you attest that the source of cannabis from a legal supplier?
  • Suppliers may be a licensed cultivator or processor or a legal foreign source, but not holders of an analytical testing licence. A legal source also does not include individuals, including those formerly registered under prior regulations or currently registered under the Cannabis Regulations.

Yes, I attest that the source of cannabis will be from a legal source.

Appendix D: Equivalent amounts (as per Schedule 3 of the Cannabis Act)

Note: Non-dried cannabis in solid and non-solid forms are considered cannabis concentrates when above 3% THC by weight.

Appendix E: Physical security plan (suggested template)

Download PDF (1 page, 123 KB)

• For project-based applications:
  • Required to be submitted if the quantity of cannabis exceeds 1 kg equivalent of dried cannabis at any of the sites within your proposed licence activities and that site does not have a cannabis processing or cultivation licence.
• Description of site(s)
• What physical security measures will be in place to prevent unauthorized access to the operations areas where research with cannabis is conducted?
• Who has access to operational and storage areas and how is this access controlled?¸
• How are the storage areas secured?
• For institution-wide applications: Description of the frameworks in place to ensure adequate physical security and prevent diversion or inversion of cannabis
  • For example, a summary of SOPs or security plans that demonstrate how operational and storage sites to be covered under the licence are designed in a manner that prevent unauthorized access and take into account appropriate measures for various quantities of cannabis kept in operational or storage areas, or other frameworks that researchers will be required to follow to ensure compliance with the Cannabis Act and its Regulations. This should also include a description of any internal compliance monitoring mechanisms and measures in place to mitigate risk based on the quantities of cannabis present at various locations where research with cannabis will take place within their institution.

Appendix F: Record keeping attestation

Download PDF (2 pages, 556 KB)

Appendix G: Submission checklist

Download PDF (2 pages, 105 KB)

Research Licence Application Checklist

Licence Ownership

• A copy of the Certificate of Corporation (if applying as a corporation)

Site Details

• Complete address of your research site(s) including:
  • Unit number, if applicable
  • Street number
  • Street Name
  • City
  • Province
  • Postal code
• A list of all the site addresses, if your research is conducted at multiple sites. In the case of an institution-wide research licence application, each building where it is known at the time of application that cannabis will be present within the boundaries of an institution.
• Confirmation that the proposed research site is not a dwelling house (i.e., residential) or an alternative address of your proposed research site
• Sales Questionnaire (if applicable)
• Research protocol(s) as per Appendix B or C
• No Objection Letter (NOL) (for clinical trials only)
• Experimental Science Certificate (ESC) (for in vivo animal studies, as applicable)

Physical Security

• For project-based applications, if the quantity of cannabis exceeds 1 kg equivalent of dried cannabis at any of the sites within your proposed licence activities and that site does not share a commercial cannabis processing or cultivation licence, a physical security description for your research site(s) that includes:
  • how the physical security of the proposed research site(s) will prevent unauthorized access to the cannabis;
  • who has access to operational and storage areas and how this access is controlled,
  • how storage areas are secured;
  • a brief description of the sites and their perimeters; and
  • how operational and storage areas are delineated.

  See Appendix E for template.

• For project-based applications, if the maximum quantity of cannabis possessed at all sites at any given time exceeds 11kg of dried cannabis (or equivalent in non-dried form) and the site does not have a processing or cultivation licence, a site plan with clear identification of the operational and storage area(s), with clearly identified perimeters and delineation of operational and storage areas.
• For institution-wide research licence applications, a description of the framework that ensures proper access and control of cannabis is maintained (e.g., summaries of SOPs for physical security, record keeping, etc. that will be required by researchers conducting activities with cannabis).

Record Keeping

• Copy of the Licence Holder / Responsible Person's Government-issued ID (e.g. driver's licence) (if applicable)
• If applying as an academic institution, research hospital or contract research organization, a copy of a Letter of Support from a senior member of the institution's administration (e.g. president, chancellor, vice president or equivalent)
• Record Keeping Attestation