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Apply for a licence

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This page describes the process of applying to Health Canada for a licence. It provides information about application tips, changes to an application, withdrawal of an application, as well as the process of creating and submitting a licence application in the Cannabis Tracking and Licensing System (CTLS).

1.0 Application tips

Your licence application must meet all the requirements for a cannabis research licence. Use the Application checklist to ensure you've submitted all the required information. Once an application is submitted, no further changes can be made.

Health Canada recommends using a document naming convention for all the information you need to submit. Following the document naming convention will help us process your application more efficiently.

If you have questions about a specific licence application, email sp-licensing-cannabis-licences-sp@hc-sc.gc.ca. The subject line should be, "Question about APP #".

2.0 Changes to an application

It is important that your licence application is accurate and reflective of your intended activities with cannabis when you submit it. After you've submitted your application, you can only do minor changes without having to withdraw your application. Any changes can delay the processing time.

3.0 Withdrawal of an application

You can withdraw your licence application at any time during the licensing process. Health Canada doesn't return information or data submitted.

4.0 Create a user account

Apply for a user account in the CTLS, if you don't already have one. Refer to the CTLS Getting Started Guide for more information on the steps to create an account.

5.0 Create a licence application

To create a licence application in the CTLS, follow the steps outlined below depending on your type of business. You can create an application for a research licence for an individual, an academic institution or research centre, or a corporation.

Tip: In the CTLS, you will see your licence application in the "Draft Licence Applications" section. Health Canada doesn't receive or process draft applications. You need to complete all sections in the application in order to submit an application for processing by Health Canada.

5.1 Applying as an individual

Important: If you apply for a licence as an individual, your name may be publicly listed on Health Canada's website, once your licence is issued. Health Canada will use your name for all official documents, and it can't be replaced by your business name. You shouldn't apply for an institution-wide research licence (IRL) as an "Individual" under the "Licence Ownership" section.

You will need to use your own individual user CTLS account to create a new licence application. Follow the steps below on the "Licence Ownership" page of the CTLS.

  1. In the "Licence Holder" section of the CTLS, select "Individual" to apply for a research licence as an individual.
  2. In the "Responsible Person" section of the CTLS, enter the CTLS Account ID of your responsible person and their alternate, if applicable.
  3. In the "Photo ID of the Responsible Person/Alternate Responsible Person", upload your valid government-issued photo ID. If you're not the responsible person, upload a valid government-issued photo ID of the responsible person and their alternate, if applicable.

Important: Only the responsible person can submit an application in the CTLS.

5.2 Applying as a part of a corporation, cooperative, or partnership

Important: If you're part of a partnership or cooperative, identify yourself as a corporation in the CTLS.

Any applicant that's a partnership, cooperative, or corporation needs to have a corporate profile in the CTLS.

The person who creates the corporate profile is the owner of that account (administrative authority). They'll be the only one who can:

If the owner of the corporate profile is no longer available, you can transfer the corporate profile to another person. For more information on how to do this, email cannabis@hc-sc.gc.ca.

5.2.1 If you already have an existing corporate profile

The owner of the corporate profile will need to follow the steps below.

  1. Create a new licence application
  2. Link the corporate profile to the licence application
  3. On the "Licence Ownership" page of the CTLS
    • In the "Licence Holder" section of the CTLS, select "Corporation" to apply for a research licence as an organization. In the drop-down menu, select the corporation name.
    • In the "Responsible Person" section of the CTLS, enter the CTLS Account ID of your responsible person and their alternate, if applicable.
    • In the "Photo ID of the Responsible Person/Alternate Responsible Person" section of the CTLS, upload a valid government-issued photo ID of the responsible person and their alternate, if applicable.

Important: The information in your corporate profile needs to be up to date when you submit a new application. Discrepancies, inconsistencies or outdated information can cause a delay in processing your application.

5.2.2 If you don't have a corporate profile

You'll need to use your individual user account to create a new corporate profile.

On the "Create corporate profile" page in the CTLS, submit the following information:

Important: You need to have at least 1 director or officer identified in the corporate profile in the CTLS. Otherwise, you won't be able to submit your licence application.

5.3 Applying as an academic institution or research centre

A research licence application can be created for an academic institution or research centre. Incorporated academic institutions are exempt from having to create a corporate profile. To apply for a research licence as an academic institution or research centre, you need to have the authority to bind the academic institution or research centre.

You'll need to use your individual user CTLS account to create a new licence application. Follow the steps below on the "Licence Ownership" page of the CTLS.

  1. In the "Licence Holder" section of the CTLS, select "Academic Institution/Research Centre" to apply for a research licence as an academic institution or research center. Enter the name, city and province or territory of the academic institution or research centre
  2. In the "Responsible Person" section of the CTLS, enter the CTLS Account ID of your responsible person and their alternate, if applicable.
  3.  In the "Photo ID of the Responsible Person/Alternate Responsible Person" section of the CTLS, upload a valid government-issued photo ID of the responsible person and their alternate, if applicable.

If you seek an IRL, you need to identify a responsible person that has the authority to bind the institution. For many institutions, such as academic institutions and hospitals, the authority to bind the establishment often resides with a senior member of the institution's administration who is often not responsible for the day-to-day activities of the research program (such as president, chancellor, vice president or equivalent). The institution may designate an administrative body to act as the institution's responsible person. The institution may also designate one alternate responsible person who meets the same qualifications and has the same responsibilities as the responsible person.

You need to provide an organization chart that describes the management structure and reporting relationships of the responsible person and the alternate responsible person. As proof of the institution's designation of the administrative body as the institution's responsible person and authority to bind the establishment, a responsible person attestation signed by a senior member of the institution's administration (such as president, chancellor, vice president, or equivalent) must be provided.

You may seek an IRL for a corporation such as a contract research organization. In this case, you need to apply as a corporation, and the responsible person attestation may be signed by the president, vice president or the chief executive officer (CEO).

6.0 Submit your application

Only the responsible person can submit the application in the CTLS once all the information is entered in your application.

Now that you're ready to submit the information you've prepared for your licence application, follow the applicable instructions on how to submit your application information.

This section describes how to submit the prepared information in the CTLS. As you go through the application sections, try to fill out each section before starting the next. If not, some fields and information might not appear, depending on your prior selections. Each section must be complete prior to submitting an application to Health Canada.

6.1 Licence ownership

This refers to the "Licence Ownership" page of the CTLS.

Important: To fill out this section, your responsible person needs to have a CTLS account.

6.1.1 Licence holder

In the "Licence Holder" section of the CTLS, choose 1 of the 3 options, depending on the licence ownership.

6.1.2 Responsible person

In the "Responsible Person" section of the CTLS, enter the CTLS Account ID of your responsible person. You may also enter the CTLS Account ID of an alternate responsible person.

In the "Photo ID of the Responsible Person/Alternate Responsible Person" section, upload a copy of your responsible person's valid government-issued photo ID (such as a driver's licence or passport). Upload a copy of the alternate responsible person's valid government-issued photo ID, if applicable.

If you're applying for an IRL, upload your organization chart in the same section.

6.2 Mailing address

This refers to the "Mailing Address" page of the CTLS.

Enter your mailing address. It needs to be the Canadian address where you'd like to receive mailed correspondence.

Tip: The mailing address isn't necessarily the same as the site address or business address. For example, you can choose to put your parent (owning) company's mailing address, or the mailing address of another site belonging to the same corporation.

6.3 Site details

This refers to the "Site Details" page of the CTLS.

6.3.1 Primary research site address

In the "Primary Research Site Address" section of the CTLS, enter:

Tip: 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, provided that it's located within your site perimeter.

6.3.2 Additional information about your research

6.3.3 Research types

Select any research types that apply to your research (in vitro, in vivo, plant genetics, cannabis product development, non-cannabis product development, research with humans such as clinical trials or non-therapeutic research on cannabis (NTRC)) in the CTLS. If your research doesn't match any of the research types, you may select "Other" type. If you're applying to conduct activities in relation to NTRC, refer to the following section for information on how to submit your NTRC application.

6.3.3.1 Non-therapeutic research on cannabis protocol

If you're conducting research activities in relation to NTRC, you need to check the NTRC box under "Research Types" for the "Non-Therapeutic Research on Cannabis Protocol" section to appear in the CTLS.

Important: If you're applying for a project-based research licence to authorize activities in relation to NTRC, you should select any boxes under Research Types that are related to your NTRC study (for example, cannabis product development).

Follow the steps below to upload your NTRC application documents in this section of the CTLS:

  1. Under the "Non-Therapeutic Research on Cannabis Protocol" section, select "Add NTRC Protocol"
  2. When the new page opens, enter the title of your protocol under the "Study Protocol Title" section
  3. From the dropdown menu below the "Study Protocol Title" section, select your research risk category
  4. In the Description box, enter a brief summary of the proposed research
  5. Under the "Research Protocol" section, upload all NTRC application documents, using the document naming conventions and in the formats described in the application checklist. Note that you can submit a maximum of 10 documents.

Tip: The brief summary in the Description box can be a synopsis taken directly from the protocol.

Important: If you're applying for an IRL to conduct activities in relation to NTRC, you can upload application documents under the "Non-Therapeutic Research on Cannabis Protocol" section.

If you don't have an NTRC protocol to submit at the time of application for your IRL, still check the NTRC checkbox under Research Types, but under the "Non-Therapeutic Research on Cannabis Protocol" section, enter the following:

Important: If you already hold an IRL, you need to submit your NTRC application through a licence change. For information on amending your research licence, email sp-licensing-cannabis-licences-sp@hc-sc.gc.ca.

6.3.3.2 Food and Drug Regulations authorization (in vivo)

If your proposed research activities involve in vivo research, specify if you require an authorization under the Food and Drug Regulations to conduct the research.

Important: If an Experimental studies certificate (ESC) is required, you may file your ESC application before or after your research licence application. If an ESC is required, you shouldn't start the research before you obtain both a research licence and an ESC.

Tip: Upload a blank document in this section regardless of whether you have or haven't filed your ESC.

Tip: If you've applied for an IRL and if you intend to conduct in vivo studies, upload a blank document.

6.3.3.3 Clinical trials (not NTRC)

If your proposed research involves a clinical trial with cannabis under the Food and Drug Regulations and you've already received a No objection letter (NOL), upload your NOL obtained from the Office of Clinical Trials in the "No Objection Letter (Clinical Trial Only)" section of the CTLS.

Important: You may file your Clinical trial application (CTA) before or after your research licence application. You may not start the research before you obtain a cannabis research licence and an NOL.

Tip: Upload a blank document in this section regardless of whether you have or haven't filed your CTA.

Tip: If you applied for an IRL and if you intend to conduct clinical trials with cannabis, upload a blank document.

6.3.4 Other research sites

If your proposed research activities will occur at multiple sites, you need to provide the address of each additional site.

For the additional sites, provide the following information:

6.3.5 Research protocol

If you're applying for a project-based research licence, upload your protocol in the "Research Protocol" section of the CTLS.

Tip: If you intend to sell cannabis plants or cannabis plant seeds, upload a completed sales questionnaire in the "Research Protocol" section in addition to your research protocol.

Important: If you're applying for a research licence to conduct activities in relation to NTRC, you need to upload a blank document under the "Research protocol" section to submit your application.

If you're applying for an IRL, upload your Research project administration framework document in the "Research Protocol" section. This applies to all IRLs, including those applying to conduct activities in relation to NTRC.

6.4 Physical security

This refers to the "Physical Security" page of the CTLS.

6.4.1 Physical security document

Project based research licences

In this section, upload the following:

Institution-wide research licences

In this section, upload the following:

6.5 Record keeping

For research and development, there are regulatory requirements for record keeping that must be met.

6.5.1 Record keeping description

In this section, upload the following:

6.5.2 Record keeping examples

Research licence applicants aren't required to submit record keeping examples. A blank document must be uploaded in this section. Alternatively, if you need additional upload space for other documents, you may upload them here.

6.6 Self-identification

This refers to the "Self-identification" page of the CTLS.

You can choose to self-identify as Indigenous affiliated. Even though self-identification is optional, you do need to fill out this page.

If you choose to self-identify

Select "Yes" if you choose to self-identify as Indigenous affiliated.

  1. Select "First Nations", "Inuit" or "Métis" depending on which Indigenous group you identify with
  2. Explain how your application is Indigenous affiliated
If you don't choose to self-identify

Select "No" if you don't self-identify as Indigenous affiliated.

6.7 Associated individuals

This refers to the "Associated Individuals" page of the CTLS.

Important: Your associated individuals need to have a CTLS account to do this step.

Enter the associated individuals' CTLS Account IDs and select "Consent to communicate". If you wish to identify a person with consent to communicate after the submission of your application, you may email Health Canada requesting to add this person to your licence.

6.8 Submission

This refers to the "Submission" page of the CTLS. Only the responsible person can submit the licence application.

On the "Submission" page of the CTLS, you need to:

Once your research licence 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. After you've submitted your application, you can only do minor changes without having to withdraw your application.

Tip: You can check the status of your application in the CTLS at any time during the application process.

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