Cannabis licence management guide

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Organization: Health Canada

Date published: 2018-11-09

Guidance to Licence Holders under the Cannabis Act and its Regulations

Table of contents

1.0 Purpose

This document (the “Guide”) provides licence holders under the Cannabis Act and the Cannabis Regulations with information on how to manage their licence after it has been issued, including renewing their licence, amending their licence, and applying for an import/export permit. It also outlines notification and reporting requirements.

2.0 Background

The Cannabis Act and its Regulations provide a licensing framework for the production, testing, packaging, labelling, sending, delivery, transportation, sale, possession or disposal, importation and exportation of cannabis or any class of cannabis.  Licences are issued by Health Canada after applicants have demonstrated that they comply with the requirements set out in the Cannabis Act and its Regulations.

After the licence is issued, it is the licence holder’s responsibility to continue to comply with all requirements in the Cannabis Act and its Regulations.
The Regulations set out requirements to manage a licence, such as renewing or amending it. There are also notification and reporting requirements that a licence holder must follow to stay compliant and maintain their licence. This guide provides licence holders with information on how they can meet these requirements.

Health Canada has established the Cannabis Tracking and Licensing System (CTLS) as the system through which applicants may apply for licences and security clearances and submit tracking reports. Licence holders also may be required to submit information to Health Canada by a means other than the CTLS, such as by email.

Health Canada publishes other guidance documents and information on its website that licence holders may use in conjunction with this document to assist in maintaining their compliance. For consistency and transparency, this guide and other guidance documents and information are updated as required to reflect changes to policies and/or operations.

3.0 Scope

This document provides guidance to licence holders under the Cannabis Act and Cannabis Regulations related to the following activities:

  • Licence renewals
  • Licence amendments
  • Changes requiring Health Canada’s approvalFootnote 1
  • Changes requiring notification to Health Canada
  • Import and export permit applications and notification requirements
  • Reporting and disclosure requirements including:
    • Notice to local authorities
    • Notice of cessation of activities
    • Notice of new cannabis products
    • Reporting promotion-related information 
    • Annual reporting of key investors
  • Licence and permit refusals, suspensions and revocations

This guide applies to those who hold licences for cultivation, processing, sale for medical purposes, analytical testing and research. It does not apply to hemp licence holders under the Industrial Hemp Regulations or cannabis drug licence holders under the Cannabis Regulations.  
Among other things, the following activities are not addressed in this guide:

  • Applying for a licence under the Cannabis Regulations. Refer to the Cannabis Licensing Application Guide for more information.
  • Requirements for individuals to access cannabis for medical purposes, as outlined in Part 14 of the Cannabis Regulations 
  • Information on cost recovery fees

The following activities are mentioned in this guide but more detailed information is found in other guides found on the Health Canada website:

  • Inventory reporting in the CTLS
  • Theft or loss reporting
  • Recall reporting
  • Serious adverse reaction reporting

For more information on requirements associated with these activities, licence holders may refer to the Cannabis Act and its Regulations and additional guidance published on the Health Canada website or may contact Health Canada as outlined in section 9 of this guide.  
This guide is based on the CTLS release 1.1.

In cases of discrepancy between the CTLS and the Cannabis Regulations or guidance, or if use of the CTLS is not possible, the licence holder should contact Health Canada. The Cannabis Regulations and this guide should be referred to for the established requirements and terminology.

4.0 Definitions and Abbreviations

4.1 Definitions

The Cannabis Act and its Regulations should be referred to for definitions. The definitions in this section are provided for greater clarity and ease of reference.
Amendment: As defined in section 32 of the Cannabis Regulations, a change related to the licence. Section 32 of the Regulations and this guide outline the specific circumstances that are defined as amendments.

Cannabis Tracking and Licensing System (CTLS): The name of the national cannabis tracking system created under the authority of the Cannabis Act, established and maintained by Health Canada to track high-level movements of cannabis and help prevent diversion from and inversion into the regulated supply chain. It is also the system that applicants should use to apply to Health Canada for a cannabis licence.

Key Investor: As defined in the Cannabis Regulations, means, in respect of the holder of a licence, a person that exercises, or is in a position to exercise, direct or indirect control over the holder by virtue of:

  • having provided money, goods or services directly or indirectly to the holder; or
  • holding an ownership interest or other right or interest in, or in respect of, a business operated by the holder or, if the holder is an organization, in or in respect of the organization.

Licence class: The Cannabis Regulations authorize activities related to cannabis by licence class, as follows:

  • Cultivation
  • Processing
  • Analytical testing
  • Sale
  • Research
  • Cannabis drug licence

Licence subclass: The Cannabis Regulations outline specific licence subclasses, as follows:
For cultivation, a licence for:

  • micro-cultivation
  • standard cultivation
  • nursery

For processing, a licence for:

  • micro-processing
  • standard processing

For sale, a licence for:

  • sale for medical purposes

Promote: As defined in the Cannabis Act, in respect of a thing or service, means to make, for the purpose of selling the thing or service, a representation — other than a representation on a package or label — about the thing or service by any means, whether directly or indirectly, that is likely to influence and shape attitudes, beliefs and behaviours about the thing or service.

4.2 Abbreviations

CTLS: Cannabis Tracking and Licensing System

4.3 Icons

The following icons are used throughout this guide.

Important: Key or cautionary information.

Tip:Supplementary information that could be helpful, including references to external documents.

5.0 Pre-reporting considerations

All licences show an expiry date. For a licence holder to continue to be authorized to conduct the activities authorized by the licence, the licence must be renewed on or before the expiry date.

The licence holder may also wish to make changes to the licence, such as modifying information about their site, their activities, or their personnel. The Cannabis Regulations defines three specific types of changes, as follows:

  • amendment requiring approval by Health Canada
  • changes requiring approval by Health Canada
  • changes requiring notification to Health Canada

Each type of change has its own requirements. Table 1: Changes to a cannabis licence summarizes the types of changes.

Table 1: Changes to a cannabis licence
Change type Example New licence application Amendment requiring approval (section 5.2 of this guide) Change requiring approval (section 5.3 of this guide) Change requiring notification (section 5.4 of this guide)

Contact and licence holder information

Change to mailing address or contact information

 

Licence holder name change

 

Change to the address of the site or building within the site where the activity is authorized (i.e., location the same)

 

Licence classes and activities

New licence class or subclass

 

Change to an authorized activity at the site or that may be conducted at each building within the site  
Includes removing an activity (e.g., no longer selling in a building).

 

Personnel changes

New quality assurance person or head of laboratory

 

Replace or add an individual who requires security clearance

 

Site changes

New site location

 

Site plan change that requires physical security measures

 

Site plan change that does not require physical security measures

 

Change to organizational security plan

 

Other

Good production practices, record keeping

No approval or notification to Health Canada is required for these elements. Licence holders are responsible for complying with the Cannabis Act and Cannabis Regulations. Health Canada may verify compliance at any time.

Licence renewal applications and proposed changes (amendments or changes requiring approval or notification) must be submitted through the CTLS.

The CTLS does not distinguish among the different types of changes. It only provides the option to select:

  1. A renewal if a change is requested within four months of the date the licence will expire, or
  2. An amendment if a change is requested more than four months from the date the licence will expire.
Follow the instructions in this guide for how to submit a licence renewal application or proposed change in the CTLS.

Once submitted, licence renewal applications and proposed changes remain open in the CTLS until Health Canada has reviewed the information and accepted or refused the change, or, in the case of a notification, has updated the file. During this time, no other changes to the licence can be made in the CTLS.
The licence holder may view the status of their application in the CTLS at any time during the process.
To submit requests for renewals or additional changes (amendment, request for approval or notification) when an action is pending in the CTLS, email HC.licensing-cannabis-licences.SC@canada.ca.

Licence holders should ensure that the file name of all files that they upload to the CTLS indicate the topic of the document and the date it was uploaded (e.g., SitePlan Update 2018Nov14). Failing to provide a clear title and a date may result in processing delays.

5.1 Licence renewals

For the licence holder to continue to be authorized to conduct the activities authorized by the licence, the licence must be renewed on or before the expiry date.

The licence holder must apply to renew their licence through the CTLS. The option to renew a licence will appear in the CTLS four months before the licence expires. Licence holders are encouraged to apply for renewal at that time.

Licence holders are not required to re-enter information to renew a licence. Health Canada assumes renewals are made based on the information on the current licence unless the licence holder specifically includes changes with the renewal application.

Licence holders who wish to change their licence should refer to the relevant sections of this guide.

If a licence holder is only applying for the renewal of their licence, they must not change or add any information in the CTLS. If a change is also desired, in additional to applying for renewal, the licence holder needs to determine whether it is considered an amendment, a change requiring approval, or a change requiring notification, or whether a new licence application is needed. The relevant sections of this guide provide more information.

When an application to renew a licence is received, Health Canada confirms:

  • the security clearance status of the individuals involved
  • the status of fees paid, if applicable
  • the status of licences issued under the Excise Act (by the Canada Revenue Agency), if applicable

An inspection may also be conducted to verify compliance. The licence holder may be asked to provide additional information to help Health Canada plan the inspection and/or renew the licence.

Once Health Canada confirms that all requirements have been met, the renewed licence, with a new expiry date, is issued.

Licence holders should ensure that the security clearances of their key personnel and licences under the Excise Act are active, and that fees have been paid. Individuals whose security clearances are close to expiring should apply to renew these as soon as possible. A minimum of six months in advance of the expiry is recommended, but some clearances may take longer.
It is the licence holder’s responsibility to ensure continued compliance with these security clearance requirements.

5.2 Amendments

Amendments, as defined in section 32 of the Cannabis Regulations, must be approved by Health Canada before they are implemented. Once they are approved, Health Canada issues an amended licence.

Table 2: Applying to amend a licence specifies the circumstances where an amendment is required as well as the required information and the instructions to submit an application for amendment in CTLS.

If the application for amendment is made within four months of the expiry date of the licence, only the renewal option appears in CTLS. In this case, amendments must be submitted with the request for renewal in the CTLS, and the licence holder must also provide a change to cannabis licence attestation form, as found in Appendix B.This form should be uploaded in the Record Keeping section of the CTLS with the application.

Table 2: Applying to amend a licence
Amendment type Example Required information CTLS instructions

A change to the name of the licence holder. This triggers an amendment to all licences associated with the licence holder.

An organization changes its name (note: additional requirements may apply to name changes as a result of mergers or acquisitions, see 5.2.1), but all other information remains the same

A document that shows the name change, for example an amended certificate of incorporation or, in the case of a partnership or cooperative, updated agreement documents

In the Corporate Profile: Modify the legal name and upload a new certificate of incorporation, articles of incorporation or agreement.

An individual changes their legal name

Government-issued ID showing the name change

In the individual account: Modify the name. Email a copy of the government-issued ID showing the name change to HC.licensing-cannabis-licences.SC@canada.ca

Change to the address (not a location change) of the site or a building within the site where the activity is authorized. Reminder: A location change requires a new licence  application.

The city changes the civic address.

A document showing the address change, such as a bill addressed to the licence holder with the new address, or notification from the city confirming the address change.

In the Site Details section: Modify the address of the site.
In the Site Survey section: As required in the initial application for a licence (section 6.4 of the Cannabis Licensing Application Guide), if multiple addresses were provided in the original licence application, the information must be uploaded as a separate document. Changes must be clearly marked. This must be uploaded in the Site Survey section of the CTLS.  
In the Record Keeping section: Upload a document showing the address change.

Change to an authorized activity at the site or an authorized activity that may be conducted at each building within the site

For example:

  • For a cultivator, to cultivate in a new building
  • For a processor, to produce cannabis in a new building
  • To add or remove an authorized activity within a building or buildings (e.g.,  sale of cannabis)
  • The proposal to modify a condition set out on the licence related to authorized activities  (e.g., the ability to sell a new cannabis class)

Required information depends on the type of authorization requested. It could include evidence demonstrating:

  • Physical security requirements
  • Organizational security plan updates
  • Good production practices
  • Record keeping and reporting

Sufficient information must be provided to demonstrate how the application requirements would be met for the proposed change.

Varies depending on the type of change.
Refer to the Cannabis Licensing Application Guide for more information.

Although the CTLS enables it, changes such as changing a licence class or subclass, adding a new site location or moving the site to another location may not be submitted as amendments. A new licence application must be submitted to Health Canada. 

Authorized activities vary depending on the class or subclass of licence. A proposal to modify an authorized activity must fall within those deemed acceptable for the licence class or subclass.
For example, a holder of a micro-processing licence that wishes to synthesize cannabis cannot do so by filing an amendment, since this is not an authorized activity under a micro-processing licence. Rather, they must apply for a new licence to be a standard processor.

Note that changes including but not limited to modifying production procedures (e.g., changing the production method for cannabis oil or its carrier oil), modifying the destruction method or location, or changing packaging and labelling are not considered amendments, changes requiring approval or notifications.

Health Canada reviews applications for amendment against the requirements, and, if all requirements are met, issues an amended licence to the licence holder. The application then appears as approved in the CTLS.

5.2.1 Mergers and acquisitions

When an organization is purchased by or merges with another organization, amendments or changes requiring approval or notification may be required. Licence holders should email Health Canada at HC.licensing-cannabis-licences.SC@canada.ca and provide details of the proposed acquisition or merger as well as contact information for follow up. Health Canada will provide further instructions based on the context.

The Cannabis Regulations allow individuals to apply for a security clearance if they will be required to hold one once a pending business transaction is completed.  

5.3 Changes requiring approval by Health Canada

Some changes are not considered amendments but must still be approved by Health Canada before they are implemented by the licence holder.

Table 3: Applying for a change requiring approval outlines the circumstances for a change requiring approval and how to submit it.

Table 3: Applying for a change requiring approval
Change type (Cannabis Regulations section) Required information CTLS instructions

For a processing licence, replacing the quality assurance person (QAP) or designating or replacing an alternate (s. 20)

The name and birth date of the proposed QAP or alternate.

Details of the proposed QAP or alternate’s qualifications, demonstrating that they have the training, experience and technical knowledge related to all the requirements in Part 5 (good production practices requirements) of the Cannabis Regulations (e.g., resume; letters of reference; diploma, degree or certificate; transcripts).

A proposed work schedule and a summary of the roles and responsibilities of the QAP or alternate, demonstrating how the person will complete required activities and maintain compliance.

Note: The QAP or alternate must hold a valid security clearance before the licence amendment will be approved.

In the Site Personnel section: Associate the account ID of the new QAP with the licence.

In the Quality Assurance Person Qualifications section: Upload the QAP or designate’s qualifications, proposed work schedule and a summary of the roles and responsibilities.

For an analytical testing licence, replacing the head of laboratory or designating or replacing an alternate (s. 24)

The name and birth date of the proposed head of laboratory or alternate.

Details of the proposed individual’s qualifications showing they have the knowledge and experience related to the duties of the position (e.g., resume, letters of reference, copy of degree, transcripts).

In the Site Personnel section: Associate the account ID of the new head of laboratory with the licence.

In the Head of Laboratory Qualifications section: Upload the person’s qualifications.

Change to the site plan that requires physical security measures to comply with the physical security requirements of the Cannabis Regulations. (Part 4, s. 33)

*Refer to the tip box immediately below for some examples.

The proposed site plan

A description of the changes, including updated information as required to demonstrate how the physical security requirements outlined in the Cannabis Licensing Application Guide will be met.

In the Site Details section: Update this section if changes are proposed to activities conducted in a specific room.

In the Physical Security section: Upload all required information including the proposed site plan and relevant physical security requirements. In addition, provide an attestation, signed by the head of security and responsible person, that the organizational security plan has been updated.

Where a licence holder is proposing changes to its site plan, they must first determine whether the proposed change requires physical security measures to comply with the Regulations. If it does, it is considered a change requiring approval by Health Canada; if it does not, it is considered a change requiring notification. Examples of site plan changes that could require physical security measures include:

  • Changes to the site design or physical barriers such as splitting a room into two rooms, adding a physical barrier to an approved space (i.e. an additional door or perimeter fence gate)
  • Changes to areas within the perimeter (e.g., adding an outdoor cultivation area)
  • Adding a new operations or storage area (e.g., building expansion, adding a new room and/or adding activities in a room).  If this results in a change to the authorized activities, it is also considered an amendment and will be processed in one application.
  • Reducing access control or monitoring and recording devices
  • Any other change that could require physical security measures

Examples of site plan changes that may not require physical security measures include:

  • Adding or upgrading visual monitoring recording devices, intrusion detection devices or alarm systems or relocating them so long as the security in the area is not impacted
  • Replacing barriers such as replacing a pre-existing door in an approved space, replacing the perimeter fence door or adding/upgrading access control devices
  • Upgrading equipment, such as the air filtration or other systems

Health Canada reviews applications for a change requiring approval against the requirements in the Cannabis Act and Cannabis Regulations. The Cannabis Licensing Application Guide provides more information. If all requirements are met, a notice of approval of change request is emailed to the licence holder and the application appears as approved in the CTLS.

5.4 Changes requiring notification to Health Canada

A licence holder may implement some changes that do not require approval. However, the licence holder must notify Health Canada within five calendar days of making the change. Changes that require notification are defined in s. 34 of the Cannabis Regulations and are summarized in Table 4: Requirements for notification.

The CTLS only provides the option to select a renewal or amendment; there is no option to select a notification. Licence holders must submit their notification request in the CTLS as a renewal (if within 4 months of licence expiry) or amendment (if more than 4 months of licence expiry). They must also submit a change to cannabis licence attestation form, as found in Appendix B to identify and attest that the changes being made are notifications. This form should be uploaded in the Record Keeping section of the CTLS.
Health Canada approval is not required for changes that require notification. However, they remain active in the CTLS until Health Canada updates the file.

Health Canada will not provide the licence holder with a formal acknowledgement of a notification, unless clarification is required. 

Table 4: Requirements for a change notification (section 34)
Notification type CTLS instructions

A change to the mailing address, telephone number, email address or facsimile number of the licence holder

For an organization: Change the contact information in the Corporate Profile section.

For an individual: Change the contact information in the Individual Account section.

These actions modify the contact information for all licences and applications associated with that licence holder.

For a specific site associated with an application: Change the contact information in the Mailing Address section.   

A change to the site plan that does not require physical security measures to comply with Part 4 of the Cannabis Regulations

*Refer to the tip box under Table 3 of this guide for some examples.

In the Physical Security section: Upload a document describing the site plan changes.

Replacing or adding individuals who must hold a security clearance (e.g., directors and officers)

Does not include changes related to the licence holder or a quality assurance person (these are considered changes requiring approval, as per section 5.3 of this guide)   

In the Corporate Profile section: Associate the account ID of the new individuals with the Corporate Profile. Deletions can also be made here.

In the Corporate Profile section: Upload modified certificates of incorporation or agreements as applicable, and a new organizational chart.

For individuals associated with a specific licence (e.g., head of security, master grower, QAP), in the Site Personnel section: Associate the account ID of the new individuals with the licence. Deletions can also be made here.

In the Physical Security section: In all cases, the relevant sections of the organizational security plan must be updated; in particular, section 1 (if head of security changes), section 2 (site organizational chart), section 3 (list of individuals in key positions and security status), and others as applicable. Upload the modified sections that have been signed and dated by the head of security and responsible person.

Refer to Part 3 of the Cannabis Regulations and the Cannabis Licensing Application Guide for more details.

NOTE: Any individual who is required to hold a security clearance must hold it before assuming the duties of the position. In addition, the licence holder must ensure they have someone in the required positions at all times.

For holders of a licence for cultivation, processing or sale, a change to the organizational security plan

In the Physical Security section: Upload the updated sections of the organizational security plan and a summary of the changes, signed and dated by the head of security and the responsible person.

In addition to the notification requirements defined in s. 34 of the Cannabis Regulations, individuals who hold security clearances must, without delay, provide Health Canada with notice in writing if they are charged with, or found guilty of, an offence under the Cannabis Act, the Controlled Drugs and Substances Act or the Criminal Code. The notice in writing should be emailed to HC.licensing-cannabis-licences.SC@canada.ca

Licence holders are responsible for ensuring that all changes they submit are accurate and meet the requirements. They should pay particular attention to changes requiring approval by Health Canada prior to being implemented. If a licence holder makes a change that does not comply with the requirements, Health Canada may take compliance and enforcement actions.

5.5 Multiple changes

A licence holder can make multiple types of changes at once (i.e., an amendment, a change requiring approval, and a change requiring notification) through one “amendment” application in the CTLS. The licence holder must provide a summary of the changes using the change to cannabis licence attestation form, as found in Appendix B, to identify and attest to the changes being made. The licence holder should upload this form in the Record Keeping section of the CTLS, with the application for change.

5.6 Amendments triggered by Health Canada  

The Cannabis Act (s. 63) allows Health Canada to amend a licence or permit if Health Canada is of the opinion that this is necessary to protect public health or safety, including to prevent cannabis from being diverted to an illicit market or activity.

In this case, Health Canada sends a written notice that sets out the reasons for the proposed amendment and gives the licence holder an opportunity to be heard, prior to the amendment taking effect.

5.7 Requests for more information and refusal to issue

In accordance with s. 62(5) of the Cannabis Act, Health Canada may ask a licence holder to submit additional information related to the application for renewal or amendment that is necessary for the Health Canada to consider the application. This is sent as a Request for More Information as outlined in the Cannabis Licensing Application Guide.

Health Canada may refuse to consider an application for renewal or amendment if any of the required information is not provided. In addition, Health Canada may refuse to issue a renewal or amendment under a number of circumstances set out in s. 62(7) of the Cannabis Act. These include:

  • The renewal or amendment is likely to create a risk to public health or public safety including the risk of diversion
  • There are reasonable grounds to believe that false or misleading information has been submitted
  • The applicant has contravened in the past 10 years the Cannabis Act, the Controlled Drugs and Substances Act, the Food and Drugs Act or any associated regulations, including an order or a condition of another licence
  • The applicant is a young person, an individual who is not ordinarily resident in Canada or an organization that was incorporated, formed or otherwise organized outside of Canada.
  • A security clearance associated with the application has been refused or cancelled
  • An individual who is required to hold a security clearance does not hold one
  • For an amendment, the combination of classes or subclasses of licences proposed at the same site. Section 29 of the Cannabis Regulations provide more details
  • The Minister is of the opinion that refusal is in the public interest
  • For a renewal or amendment, the licence holder does not hold a cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required

In these cases, Health Canada may send an intent to refuse notice, either to refuse to consider the application or to refuse to issue a licence. This notice will generally provide the applicant with 30 days to respond, after which a notice of refusal will be issued.

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

If an application for renewal is refused and the licence expires, the licence holder is no longer authorized to conduct the activities and must stop all activities immediately as of the date of expiry. If activities are not stopped, Health Canada may take compliance and enforcement actions, or, in appropriate circumstances, may make a referral to law enforcement.

6.0 Import/Export Permits

6.1 Applications for an import or export permit for medical or scientific purposes

Under Part 10 of the Cannabis Regulations, licence holders who wish to import or export cannabis for medical or scientific purposes must hold an import or export permit for each shipment of cannabis that is imported or exported. Table 5: Import and export permit application requirements outlines the application requirements for an import or export permit.

Table 5: Import and export permit application requirements
Application requirement  Import permit application requirement Export permit application requirement

Licence holder information

Name of licence holder

 

 

Mailing address of licence holder

 

 

Licence number

 

 

Transit details

The name and address of the importer

 

The name and address of the exporter

 

The port of entry into Canada

 

The port of exit from Canada and country of import

 

The address of the customs office where the shipment will be delivered

 

The address of the customs office, sufferance warehouse or bonded warehouse where the shipment will be delivered, if applicable

 

Each mode of transport used

 

 

Any country of transit or transhipment, if applicable

 

 

Shipment details 

Anticipated shipment date , if known

 

 

Description of the cannabis

 

 

Name and address of the exporter

 

 

Intended use of the cannabis

 

 

Brand name, if applicable

 

 

Quantity of the cannabis

 

 

Percentage of THC weight by weight (w/w) and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds

 

 

Competent authority authorization

Import permit from the competent authority in the country of import

 

An Import or Export Permit Application Form for medical or scientific purposes, as found in Appendix C and Appendix D respectively,should be used to apply for a permit. Email the completed form to HC.import-export-cannabis-importation-exportation.SC@canada.ca. The subject of the email and the file name should indicate Import/Export Permit Application Form.

Additional information on the circumstances for permitting the importation or exportation of cannabis for medical or scientific purposes can also be found on the Health Canada website.

Permits are valid only until the earliest of the date on which the:

  • shipment is imported/exported
  • permit expires or is revoked
  • licence expires or is revoked
  • date the import or export permit is revoked by the competent authority of the country of import/export pertaining to the shipment

Import/export permit holders are also authorized to possess, transfer, transport, send or deliver, or in the case of export, sell, the shipment of cannabis to the extent necessary to import or export the cannabis.

6.2 Notification of shipment

An import or export permit holder must provide a copy of the import or export permit to the customs office at the time of import or export.

Within 15 days after the release of a shipment of cannabis in Canada or the export of a shipment of cannabis, the permit holder must provide Health Canada with specific information as outlined in s. 209 (for import) and s.218 (for export) of the Cannabis Regulations using the cannabis shipment detail notification form, as found in Appendix E. Email the completed form to HC.import-export-cannabis-importation-exportation.SC@canada.ca. The subject line of the email and the file name should indicate Import/Export Notification of Shipment and the permit number.

The holder of an import permit must ensure that after the imported cannabis is released from the Canada Border Services Agency, it is transported directly to the site set out in the licence referred to in the permit.

Health Canada may provide information received in the import or export permit application as well as the permit and the notification of shipment or the status (i.e., if the permit has been suspended or revoked) to a customs officer to verify compliance with the Cannabis Regulations.

6.3 Refusal to issue an import or export permit

Health Canada may refuse to consider an application for an import or export permit if required information is not provided.

In addition, Health Canada may refuse to issue an import or export permit under a number of circumstances set out in s. 62(7) of the Cannabis Act and outlined in section 5.7 of this guide.

Sections 206 and 215 of the Cannabis Regulations outline additional reasons to refuse to issue an import or export permit, including:

  • The applicant does not hold a licence
  • Health Canada has reasonable grounds to believe that the shipment to which the permit application pertains contravenes the Cannabis Regulations or the laws of the country of import or export or any country of transit or transshipment
  • In the case of import, the importation of the cannabis is for the purpose of exporting it
  • In the case of export, it does not comply with the permit for importation issued by a competent authority of the country of import

In these cases, Health Canada may send an intent to refuse notice, either to refuse to consider an application, or to refuse to issue a permit. The notice will generally provide the applicant with 30 days to respond, after which a notice of refusal will be issued.

The notice of refusal closes the file and sets out the specific reasons or deficiencies that resulted in the decision to refuse to consider the application or issue a permit. All decisions to refuse an application are without prejudice to filing a new application for a permit. 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.

7.0 Other Notification and Reporting Requirements

This section details other notification and reporting requirements outlined in the Cannabis Regulations. Appendix A: Summary of Other Notification and reporting requirements summarizes these requirements, including the frequency and manner to submit them.

7.1 Notice to local authorities

Under s. 35 of the Cannabis Regulations, holders of licences for cultivation, processing and sale that authorize the possession of cannabis must provide written notice to the local authorities within 30 calendar days of the following events:

  • issuance of the licence
  • amendment to the licence
  • suspension, reinstatement or revocation of the licence

The notice must be provided to a senior official of the following local authorities:

  • the local government
  • the local fire authority
  • the local police force or Royal Canadian Mounted Police detachment that is responsible for providing policing services to that area

The notice must include:

  • the name of the licence holder
  • the site address on the licence
  • a description of the applicable circumstances including details of any amendment if applicable
  • the effective date of the circumstance

Licence holders are also required to provide a copy of the notice to Health Canada at HC.licensing-cannabis-licences.SC@canada.ca. The subject of the email and the file name should indicate Post-Licensing Notification to Local Authorities.

7.2 Notice of cessation of activities

The Cannabis Regulations (s. 36) require that licence holders notify Health Canada of their intent to cease authorized activities 30 calendar days before the activities cease.

Notification of intent to cease conducting activities is required if the cessation will occur before or on the date the licence will expire.  
The notice must include the following information:

  • The date on which the activities are expected to cease
  • A description of the manner in which any cannabis remaining at the site as of the date will be disposed of by the licence holder, including
    • If it will be sold or distributed, the name and address of the person to which it will be sold or distributed to
    • If it will be destroyed, the day and location of the destruction 
  • The location at which the licence holders’ records, reports, electronic data and other documents that are required to be retained will be retained after activities have ceased
  • The contact information of a person from whom further information can be obtained after activities have ceased

The cannabis notice of cessation of activities form, as found in Appendix F, should be used to provide the required information to Health Canada. Email the completed form to HC.licensing-cannabis-licences.SC@canada.ca. The subject line and the file name should indicate Notice of Cessation of Activities.

The CTLS provides the option to cancel a licence. This should be used once the form is submitted. Regardless, Health Canada will cancel the licence after receipt of the form.

If there are further changes after having ceased activities, the licence holder must submit an updated form to Health Canada using the process outlined above. For example, if the address of the location where the records, reports and documents are stored has changed, or the person who can be contacted for more information has changed, the licence holder must submit an updated form.

Under section 222 of the Cannabis Regulations, documents or information that must be retained and for which the retention period has not yet ended must continue to be retained even if the individual ceases to hold a licence.

If cannabis inventory will be sold or distributed before cessation of activities, the person it is sold or distributed to must be authorized to conduct the specific activities. For example, if they are planning to possess or sell, they must be authorized for those activities.

7.3 Record of key investors

This requirement applies to licence holders for cultivation, processing and sale for medical purposes that are not organizations whose equity securities are listed on a published market. Further definition of key investors can be found in the Cannabis Regulations and the Cannabis Licensing Application Guide.

The Cannabis Regulations (s. 241) require that licence holders for cultivation, processing or sale maintain a record of key investors.

A copy of this record must be provided to Health Canada no later than January 31 of each given year. Further information on the form and manner to submit this information will be provided by Health Canada at a later date.

The licence holder must retain a copy of the key investor record for at least two years after the day on which the licence holder ceases to be required to maintain it. In addition, the record must be available at the site specified in the licence and be maintained in a manner to enable an audit of it to be made in a timely manner.
Records related to former investors must continue to be retained in the record even if the person ceases to be an investor.
Licence holders must not delete any information from the record.

7.4 Notice of new cannabis products

This requirement only applies to licensed processors.

The Cannabis Regulations (s. 244) require that licensed processors notify Health Canada of their intent to sell a cannabis product, except cannabis plants or cannabis plant seeds, which they have not previously sold in Canada. This notification must be provided to Health Canada at least 60 days before making the cannabis product available for sale.

A new cannabis product is one that is distinct from other products sold by the licence holder. For example, a new cannabis product could include:

  • A product of a new cannabis class (i.e., dried cannabis, fresh cannabis, cannabis oil) or form (e.g., oil in capsules)
  • Cannabis that is contained in a cannabis accessory or form (e.g., pre-rolled joints or capsules)
  • A new method of administration (e.g., smoking, vaporizing, oral, topical, sublingual, nasal)
  • Anything else that significantly distinguishes the product

Changing the package (e.g., the size of a container), label, suppliers of accessories, carrier oils or colourants are generally not considered to be a significant characteristic change.

Licence holders are invited to contact Health Canada at HC.licensing-cannabis-licences.SC@canada.ca if they are uncertain as to when a proposed new product requires notification to Health Canada.

Notification of a new product does not constitute approval for sale by Health Canada, nor that the product complies with legislative requirements.
Licence holders are responsible for making sure their cannabis products meet the requirements of the Cannabis Act and the Cannabis Regulations. If there are concerns with a submitted notification (e.g., cannabis class is not authorized by the licence), compliance and enforcement actions may be taken.

As per the Regulations, the information that must be submitted includes:

  • the cannabis class
  • a description of the product including the brand name
  •  the date on which the cannabis product is expected to be made available for sale

Licence holders must email the information to HC.licensing-cannabis-licences.SC@canada.ca. The subject line and the file name should indicate New Cannabis Product Notification.

The licence holder must retain a copy of the notice for at least two years after the date on which the cannabis product is expected to be made available for sale. (s.244 (2))

7.5 Reporting information related to promotions

The Cannabis Act outlines general prohibitions related to promoting cannabis, cannabis accessories and services related to cannabis. The primary objective is to protect the health of young persons by restricting their access to cannabis and to protect young persons and others from inducements to use cannabis. For more information on promotion prohibitions, refer to the Cannabis Act and the Fact Sheet: The Cannabis Act - Promotion Prohibitions.

As per the Cannabis Regulations (s. 245), all licence holders are required to provide information about any promotional activities of cannabis, cannabis accessories or services related to cannabis that they conduct.

The information that must be submitted includes the total amount of money spent in a given calendar year on promotion, separated by promotions that are directed at consumers who purchase cannabis at the retail level in Canada, and all others. The information must also include a description of the types of promotion on which the money was spent.

This information must be provided no later than March 31 of the year following the year when the promotion occurred. Further information on the form and manner to submit this information will be provided by Health Canada at a later date.

Health Canada may request additional information related to promotion, in accordance with s. 43 of the Cannabis Act. This could include copies of promotional materials.

“Consumers who purchase cannabis at the retail level” includes those who purchase from a retailer authorized by their province or territory as well as those who purchase directly from a licence holder authorized for sale for medical purposes. Activities not directed at consumers could encompass a wide variety of individuals or companies, such as promotions targeted to health care practitioners.

Services related to cannabis includes clinics where advice may be provided, or specialized delivery services for cannabis, among others.

The licence holder must retain a copy of the information sent to Health Canada for at least two years after the date it is sent, as well as samples or copies of any promotional materials for at least two years after the event or promotion take place. (s. 236)

7.6 Other reporting requirements

The Cannabis Act and the Cannabis Regulations include a number of additional reporting requirements for licence holders. Details on these requirements can be found in other guidance documents on the Health Canada website.  

Requirement

  • Inventory reporting into the Cannabis Tracking System (Part 6 of the Cannabis Act and Ministerial Order)
  • Theft or loss of cannabis (s. 246 of the Cannabis Regulations)
  • Recalls (s. 247 of the Cannabis Regulations)
  • Adverse Reactions (s. 248 of the Cannabis Regulations)

Health Canada has annual reporting obligations to the International Narcotics Control Board and may request information from licence holders, including analytical testing and research licence holders, to meet these needs.

8.0 Licence Suspensions and Revocations

8.1 Suspension of a licence or permit

Health Canada may suspend a licence under s. 64(1) of the Cannabis Act or s.30 of the Cannabis Regulations without prior notice if: 

  • Health Canada has reasonable grounds to believe that the suspension is necessary to protect public health or public safety, including preventing cannabis from being diverted to an illicit market or activity
  • An individual who is required to hold a security clearance in respect of the licence does not hold such a security clearance
  • The licence holder has failed to pay a fee in relation to the licence
  • The licence issued under subsection 14(1.1) of the Excise Act, 2001 is suspended under subsection 23(2) of that Act

Health Canada may suspend an import or export permit without prior notice if Health Canada has reasonable grounds to believe that the suspension is necessary to protect public health or public safety, including preventing cannabis from being diverted to an illicit market or activity. 

In the case where Health Canada intends to suspend a licence or import or export permit, Health Canada issues a notice of suspension that sets out the reasons for the suspension. The suspension takes effect immediately.  

Licence holders may be heard by providing Health Canada with reasons why they believe the suspension is unfounded within 10 days of receipt of the notice. This must be emailed to HC.licensing-cannabis-licences.SC@canada.ca. If the reasons for the suspension no longer exist or the licence holder provides sufficient information and evidence that might demonstrate that the suspension was unfounded, Health Canada may reinstate the licence or permit.

8.2 Revocation of a licence or permit

Health Canada may revoke a licence or permit under a number of circumstances set out in s. 65 of the Cannabis Act. These include if:

  • there are reasonable grounds to believe that it was issued on the basis of false or misleading information or false or falsified documents submitted in, or in support of, the application
  • the licence holder has, since its issuance, 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 these Acts
  • there are reasonable grounds to believe that the holder has, since its issuance, contravened:
    • an order made under the Cannabis Act, the Controlled Drugs and Substances Act or the Food and Drugs Act, or
    • a condition of another licence or permit issued to the holder under the Cannabis Regulations
  • information received from a peace officer, a competent authority or an international organization of states or any of its institutions raises reasonable grounds to believe that its holder has been involved in the diversion of cannabis, or of any controlled substance or precursor as those terms are defined in subsection 2(1) of the Controlled Drugs and Substances Act, to an illicit market or activity
  • the holder is an individual who has, since its issuance, ceased to be ordinarily resident in Canada
  • since the issuance of the licence or permit, a security clearance in respect of the licence or permit has been cancelled
  • the Minister is of the opinion that it is in the public interest to revoke it
  • any prescribed circumstance exists

An import or export permit can also be revoked if the:

  • licence has been revoked
  • permit that has been suspended is not reinstated because the reasons for the suspension still exist or the permit holder has not provided sufficient information or evidence that might demonstrate to Health Canada that the suspension is unfounded
  • for an import permit, the importation of the cannabis is for the purpose of exporting it

In the case where Health Canada proposes to revoke a licence or permit, Health Canada sends a notice in writing that includes the reasons for the proposed revocation and provides the permit holder with an opportunity to be heard.

9.0 Contact Us

For specific questions related to a specific licence application, email HC.licensing-cannabis-licences.SC@canada.ca and indicate the application file number, the applicant name and the subject of the correspondence in the subject line of the email. Meeting or teleconference requests will be 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 or contact the Cannabis Legalization and Regulation Branch by phone at 1-866-337-7705.

10.0 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 need to comply with the Cannabis Act and its Regulations.

We would appreciate receiving your feedback on whether this guide was useful, and we welcome your suggestions for improvement. Email your feedback to us at cannabis@canada.ca and indicate in the subject line: “Feedback on Cannabis Licence Management Guide.”

Your comments will help us improve this guide and better serve all applicants and licence holders.

Appendix A: Summary of Other Notification and Reporting Requirements

This table summarizes the other notification and reporting requirements outlined in this guide. It does not include notifications regarding a licence under s. 34 of the Cannabis Regulations; these are detailed in Table 1: Changes to a cannabis licence.

Table 6: Summary of notification and reporting requirements (as outlined in section 7 of this guide)
Requirement and section of the Cannabis Regulations Frequency Form and manner

Notice to local authorities  (s.35)

Within 30 days of licence issuance, amendment, suspension, reinstatement or revocation

Email copy of notice to Health Canada

Notice of cessation of activities (s. 36)

Within 30 days of intent to cease authorized activities

Email completed notice of cessation of activities form

Record of key investors (s. 241)

Annually, no later than January 31

Refer to the Health Canada website for more information

Notice of new cannabis products (s. 244)

At least 60 days prior to making a new cannabis product available for sale

Email information to Health Canada

Reporting information related to promotions (s. 245)

Annually, no later than March 31 of the year following the year when the promotion took place

Refer to the Health Canada website for more information

Organizational Security Plan (s. 45)

On request of Health Canada

Email updated organizational security plan

For other reporting requirements, such as inventory reporting, theft or loss, recalls, and adverse reactions, refer to the Regulations and other guidance as listed in section 7.6 of this guide.

Appendix B: Change to Cannabis Licence Attestation Form

PDF version (740 KB, 2 pages)

This form should be included as part of an application to Health Canada for an amendment, a change requiring approval or a notification under s.34 of the Cannabis Regulations.  It should be uploaded in the “Record Keeping” section of the CTLS in the application. Please see details in section 5.0 of the Licence Management Guide for other information required to assess the change.

SECTION 1: Administrative information 

Name of licence holder:
Licence number:
Responsible Person name:
Contact details (email and phone number):

SECTION 2: Change being requested 

Amendment (Requires Health Canada approval as per s.32 of the Cannabis Regulations)

  • Change to the name of the licence holder
  • Change to the address of the site or building within the site where the activity is authorized
  • Change to the authorized activity at the site or the authorized activity that may be conducted at each building within the site.

Change requiring approval (Requires Health Canada approval as per sections 20, 24 and 33 of the Cannabis Regulations)

  • Change to site plan that would require physical security measures to be carried out in order to comply
  • Change to Quality Assurance Person
  • Change to head of laboratory

Change requiring notification (must be submitted within five days of making the change)
(As per s. 34 of the Cannabis Regulations)

  • Change to the telephone number, email address or the facsimile number of the licence holder
  • Change to the site plan that would not require physical security measures to be carried out in order to comply
  • Replacing an individual who must hold a security clearance referred to in any of paragraphs 50(b) to (g), (i) and (j) or the addition of another such individual, other than an individual who is designated as an alternate for the position of quality assurance person referred to in section 19
  • For holders of a licence for cultivation, a licence for processing or a licence for sale, a change to the organizational security plan

Effective date of change:
Description of change:

SECTION 3: Attestation by responsible person

  • If my licence expires before the amendment or change requiring approval is approved, I would like Health Canada to renew my licence under the existing conditions of my current licence while the existing application (e.g., amendment, change requiring approval) continues to be processed separately. 

I hereby attest that all of the information provided is correct and complete to the best of my knowledge. By submitting the information in the CTLS, I attest that all changes are reflected on this form and no other changes have been made in the system.

Signature of responsible person
Date

Appendix C: Application for Permit to Import Cannabis for Medical or Scientific Purposes

PDF version (740 KB, 2 pages)

This form should be used to apply for a permit to import cannabis for medical or scientific purposes under the Cannabis Regulations. Email the completed form to HC.import-export-cannabis-importation-exportation.SC@canada.ca. The subject of the email and the file name should indicate Import Permit Application Form.

SECTION 1: Licence holder information 

Name of Licence holder
Mailing address
Licence number

SECTION 2: Transit details 

Name of exporter
Country of export
Address details
Port of entry in Canada
Address of customs office to which shipment is to be delivered
Each mode of transportation used
Any country of transit or transhipment, if applicable

SECTION 3: Shipment details 

Anticipated shipment date, if known
Description of cannabis
Intended use of cannabis
Brand name, if applicable
Quantity of cannabis
The percentage of THC w/w and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds

SECTION 4: Attestation 

I hereby attest that all of the information submitted in support of the application is correct and complete, to the best of my knowledge and that any imported cannabis is for medical or scientific purposes only.
Name of responsible person 
Signature
Date

Appendix D: Application for Permit to Export Cannabis for Medical or Scientific Purposes

PDF version (740 KB, 2 pages)

This form should be used to apply for a permit to export cannabis for medical or scientific purposes under the Cannabis Regulations. Email the completed form to HC.import-export-cannabis-importation-exportation.SC@canada.ca. The subject of the email and the file name should indicate Export Permit Application Form.

SECTION 1: Licence holder information 

Name of licence holder
Mailing address
Licence number

SECTION 2: Transit details

Name of importer
Country of import
Address details
Port of exit from Canada
Address of customs office, sufferance warehouse or bonded warehouse to which shipment is to be delivered, if applicable
Each mode of transportation used
Any country of transit or transhipment, if applicable

SECTION 3: Shipment details 

Anticipated shipment date, if known
Description of cannabis
Intended use of cannabis
Brand name, if applicable
Quantity of cannabis
The percentage of THC w/w and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds

SECTION 4: Competent authority authorization 

Attach the import permit from the competent authority in the country of import

SECTION 5: Attestation 

I hereby attest that all of the information submitted in support of the application is correct and complete, to the best of my knowledge and that any exported cannabis is for medical or scientific purposes only.
Name of responsible person
Signature
Date

Appendix E: Cannabis Shipment Detail Notification Form

PDF version (740 KB, 2 pages)

This form should be used to notify Health Canada within 15 days after the release of a shipment of cannabis in Canada or the export of a shipment of cannabis for medical or scientific purposes under the Cannabis Regulations. Email the completed form to HC.import-export-cannabis-importation-exportation.SC@canada.ca. The subject line of the email and the file name should indicate Import/Export Notification of Shipment and the permit number.

SECTION 1: Import/export shipment details

Name of licence holder
Licence number
Permit type

  • Import permit
  • Export permit

Import or export permit number
Date shipment released/exported
Description of the cannabis
Intended use of the cannabis
Brand name, if applicable
Quantity of cannabis
The percentage of THC w/w and CBD w/w of the cannabis, except in the case of cannabis plants and cannabis plant seeds

SECTION 2: Attestation 

I hereby attest that all of the information submitted in support of the application is correct and complete, to the best of my knowledge.
Name of responsible person
Signature
Date

Appendix F: Cannabis Notice of Cessation of Activities Form

PDF version (653 KB, 3 pages)

This form should be used by licence holders to notify Health Canada of their intent to cease authorized activities as required by the Cannabis Regulations. Notification is required 30 calendar days before the activities cease. The completed form should be emailed to HC.licensing-cannabis-licences.SC@canada.ca. The subject line and the file name should indicate Notice of Cessation of Activities.

Part A: Administrative information   

  • New notice of cessation of activities
  • Update to previously submitted information 

(To update previously submitted information, outline the updates in the appropriate section of this form).
Name of licence holder:
Licence number:

Part B: Required information

Date on which activities are expected to cease:
Responsible person:
Describe how the licence holder will dispose of any cannabis remaining at the site
Total quantity of cannabis remaining on site as of date of cessation
Will any cannabis remaining on site be sold or distributed, in whole or in part?

  • Yes
    • If yes:
      Name and address of the person to whom it will be sold or distributed:
      Quantity to be sold or distributed:
  • No

Will any cannabis be destroyed in whole or in part?

  • Yes
    • If yes:
      Date when the destruction is to take place:
      Location where destruction will take place:
      Quantity to be destroyed:
  • No

Other Information
Address where the licence holder’s records, reports, electronic data and other documents that are required to be retained under the Cannabis Act will be retained after activities have ceased:
Person from whom Health Canada may obtain further information after activities have ceased
Name:
Address:
Telephone:
Email:

SECTION 3: Attestation by responsible person 

I hereby attest that all of the information provided in this report is correct and complete, to the best of my knowledge.
Full name of responsible person
Signature of responsible person
Date

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