Cannabis licence management guide

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Organization: Health Canada

Date published: 2018-11-09

Date updated: 2019-08-30

Effective immediately this guide should no longer be used for cultivation, processing and sale for medical purposes licence holders. Please contact cannabis@canada.ca to request the updated version of this document that reflects amendments to the Cannabis Regulations effective October 17, 2019.
Research and analytical testing licence holders should continue to refer to this version of the guide as released on June 13, 2019.

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 or 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 Cannabis 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.

The following activities that are closely connected to licensing requirements are not addressed in this guide:

  • Applying for a licence under the Cannabis Regulations. Refer to "Apply for a licence under the Cannabis Act and Regulations" page on the Health Canada website for more information.
  • Requirements for individuals to accessing cannabis for medical purposes, as outlined in Part 14 of the Cannabis Regulations
  • Paying cost recovery fees

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

  • Cannabis tracking system monthly reporting
  • Theft or loss reporting
  • Recall reporting
  • Serious adverse reaction reporting

For more information on 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 1.2.

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.

Brand element: As defined in the Cannabis Act, includes a brand name, trademark, tradename, distinguishing guise, logo, graphic arrangement, design or slogan that is reasonably associated with, or that evokes ,

  • cannabis, a cannabis accessory or a service related to cannabis; or
  • a brand of any cannabis, cannabis accessory or service related to cannabis.

Brand name: The name, whether or not includes the name of any licence holder, in English or French, that is assigned to the cannabis product, under which the cannabis product is sold or promoted, and that is used to distinguish the cannabis product.

Cannabis Tracking System (CTS): The system created under the authority of the Cannabis Act and 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.

Cannabis Tracking and Licensing System (CTLS): The online portal used to apply to Health Canada for a cannabis licence and used by licence holders to manage their licence, including applying for amendments or changes to a licence and submitting monthly reports.

CTLS icons: the following icons are used to manage licences and applications in the CTLS:

Under the Licences tab in the CTLS
Icon Definition
edit icon
  • Initiate an application to amend a licence
renew icon
  • Initiate an application to renew a licence (appears in the CTLS four months before the licence expires)
cancel icon
  • Request cancellation of the target licence. Note: This icon locks the licence record and sends a cancellation request to Health Canada. Do not choose this to withdraw an application to amend a licence.
Licences applications in the CTLS
Icon Definition
edit icon
  • Edit draft application
delet icon
  • Withdraw a draft application
  • Withdraw a submitted application

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;
  • 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 application: The form that must be submitted through the CTLS to apply for, change or renew a licence as follows:

  • New licence applications: To apply for a new licence
  • Licence amendment application: To apply to change a licence or licensed site
  • Licence renewal application: To apply to renew a licence or a licence that is within four months of the expiry date

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 record: The complete record of all information related to a licensed site as approved by Health Canada. The record includes the information displayed on the physical (paper) licence as well as information regarding the site that is not displayed on the physical licence (e.g., activities and rooms within a building).

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.

Site: As defined in the Cannabis Regulations means, in respect of a holder of a licence, an area that is used exclusively by the holder that consists of at least one building or one part of a building. This typically includes:

  • Storage area: As defined in the Regulations means, in respect of a site set out in a licence, an area of the site where cannabis is stored.
  • Grow area: As defined in the Regulations means, in respect of a site set out in a licence, an area of the site where cannabis plants are cultivated, harvested or propagated.
  • Operations area: As defined in the Regulations means, in respect of a site set out in a licence, an area of the site - other than a storage area - where cannabis is present as a result of any activities conducted under the licence. It includes a grow area.

4.2 Abbreviations

CTS:
Cannabis Tracking System
CTLS:
Cannabis Tracking and Licensing System
GPP:
Good Production Practices
QAP:
Quality Assurance Person

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 Licence Renewals and Changes

A licence holder must renew their licence before it expires. 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 outline two types of changes, as follows:

  • Changes requiring approval by Health Canada (as defined under section 20, 24, 32 and 33 of the Cannabis Regulations)
  • Changes requiring approval must be requested by submitting a licence amendment application in the CTLS. Refer to section 5.2 in this guide for more information about changes requiring approval.
  • Changes requiring notification to Health Canada (as defined under section 34 in the Cannabis Regulations)
  • Changes requiring notification must be sent by email. Refer to section 5.3 Changes Requiring Notification to Health Canada for instructions on submitting notifications.

Important: The CTLS does not distinguish between the different types of changes as defined in the Cannabis Regulation. Therefore, it is critical licence holders be familiar with the regulatory requirements and follow the processes as outlined in this guide.

Table 1: Changes related to a licence lists the types of changes that may be made, as well as which require approval and which require notification. Some changes only apply to certain licence types (e.g., change of Quality Assurance Person only applies to licences for standard or micro-processing).

Table 1: Changes related to a licence
Type of change Example

Change requiring approval

See section 5.2 of this guide

Change requiring notification

See section 5.4 of this guide

Contact and licence holder information Change a mailing address or contact information -

 

Change licence holder name

 

-
Change the address of the site or building within the site where the activity is authorized, but the location stays the same

 

-
Licence classes and activities Add a new licence class to a licensed site

 

-

Change an authorized activity at the site or at each building within the site

Remove an activity, such as no longer selling in a building.

 

-
Personnel changes Change the QAP or head of laboratory

 

-
Change other individuals who require a security clearance such as the responsible person, corporate personnel, master grower. -

 

Site changes Change to site plan that requires physical security measures

 

-
Change a site plan that does not require physical security measures -

 

Change an organizational security plan -

 

Licence conditions Change the conditions on the licence

 

-
Other Change good production practices or record keeping No approval from or notification to Health Canada is required. Licence holders are responsible for ensuring that all of their activities comply with the Cannabis Act and Cannabis Regulations. This includes meeting good production practices and following record keeping requirements. Health Canada may verify compliance at any time.

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 shown on the licence.

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 and the licence holder is encouraged to apply for renewal at that time.

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

Important: Licence holders who wish to make changes to their licence when they renew it may do so by following the process outlined in 5.2 of this guide. However, they may be required to withdraw and resubmit a licence renewal application with the changes removed if it is determined that the processing time for one or more of the requested changes may extend past the expiry date of the licence.

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

  • the security clearance status of the individuals involved, if applicable
  • the status of fees paid, if applicable
  • the status of licences issued under the Excise Act, 2001 (by the Canada Revenue Agency), if applicable

An inspection may also be conducted to verify ongoing compliance with the requirements of the Cannabis Act and Regulations. 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.

Tip: Licence holders should ensure that the security clearances of their key personnel and their licence under the Excise Act, 2001 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 Changes requiring approval by Health Canada

Changes requiring approval must be submitted as a licence amendment application in the CTLS, and must be approved by Health Canada before they are implemented. Once they are approved, Health Canada issues an amended licence or, where an update to the physical licence is not necessary, a letter approving the changes.

Only the responsible person is able to initiate and submit a licence amendment application in the CTLS.

A licence amendment application is initiated by opening the Licences tab in the CTLS and clicking the green pencil icon next to the licence to be amended. Click "Confirm" and the status of the target licence will change from "Issued" to "Amendment in progress". To edit and submit the application, open the Licence Applications tab in the CTLS and click the green pencil icon next to the newly generated draft amendment application.

Once the application is submitted, the licence holder can no longer view or edit it. The status of the target licence remains as "Amendment in Progress" until Health Canada reviews the information and accepts or refuses the proposed change(s). During this time, no other changes to the licence can be submitted through the CTLS.

Licence holders may withdraw and resubmit an application at any time if they wish to make significant changes to it. They are encouraged to email Health Canada when they change and resubmit an application in the CTLS. Applications that are withdrawn and resubmitted are likely to be subject to processing delays.

Table 2: Applying to make changes to a licence shows the changes that require a licence amendment application to be submitted in the CTLS to request approval, as well as the required information and the instructions on how to submit the application in the CTLS.

Important: A Change to the Cannabis Licence Attestation Form (See appendix B) must be submitted with each application to amend a licence. This form should be uploaded in the Record Keeping section of the application. Licence holders may be asked to withdraw and resubmit a licence amendment application if the information on the attestation does not accurately reflect the information in the application (e.g., the attestation indicates additional grow rooms but these were not added under the Site Details section of the application for an amendment).

Tip: New draft amendment or licence renewal applications will automatically have all required fields filled in with information from the most recent licence record. Therefore, it is only necessary to update information in the sections relevant to the changes being requested and upload the Change to Cannabis Licence Attestation form into the Record Keeping section before submitting the application.

Licence holders should ensure that the file name of all documents that they upload to the CTLS indicates the topic of the document and the date it was uploaded (e.g., SitePlan [Upload date YYYY-MM-DD]). Failing to provide a clear title and a date may result in processing delays.

Table 2: Changes requiring approval by Health Canada (amendment application required)
Type of amendment Required information CTLS instructions

A change to the name of the licence holder.

Note: This triggers an amendment to all licences associated with the licence holder.

Corporation: 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 documents.

Draft licence amendment applications will be automatically initiated for each licence associated with the corporate profile and will need to be completed, submitted and approved before a licence with the modified name can be issued.

Individual: Government-issued ID showing the name change

In the individual's user account: Modify the name and email a colour copy of the government-issued ID showing the name change to HC.licensing-cannabis-licences.SC@canada.ca

Draft licence amendment applications will be automatically initiated for each licence associated with the licence holder and will need to be completed, submitted and approved before a licence with the modified name can be issued.

Change to the address (not a location change) of the site or a building within the site where the activity is authorized.

Note: A location change requires a new licence application.

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.

Initiated a licence amendment application and update the following sections:

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, and Change to Licence Attestation form describing the change.

Change to an authorized activity at the site (e.g., addition of cultivation, processing or medical sales) or an authorized activity that may be conducted at each building within the site

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.

Initiated a licence amendment application and update the following sections:

In the Site Activities section, indicate any new licence classes to be added to the existing licensed site.

Note that requests to add standard or micro processing licence can only be approved if the proposed QAP holds a valid security clearance. As security clearance processing timelines can vary greatly, licence holders may be required to withdraw their application and resubmit it after the proposed QAP has been granted a security clearance if there are other changes requiring approval that need to be submitted.

In the Site Details section, indicate any changes to the specific activities conducted within each room or building

In the Record Keeping section, upload a Change to Cannabis Licence Attestation form describing the changes.

Applies to a holder of a processing licence: Replacing the QAP or designating or replacing an alternate (section 20 of the Cannabis Regulation)

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 application will be approved.

Initiate a licence amendment application and update the following sections:

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.

In the Record Keeping section, upload a Change to Lice Attestation form describing the changes.

Applies to a holder of an analytical testing licence: Replacing the head of laboratory or designating or replacing an alternate (section 24 of the Cannabis Regulations)

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

A description of the proposed head of laboratory's or alternate's qualifications in respect of the matters referred to in subsection 23(2) of the Cannabis Regulations.

Initiate a licence amendment application and update the following sections:

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 head of laboratory's or alternate's qualification.

In the Record Keeping section: Upload a Change to Cannabis Licence Attestation form describing the changes.

Change to the site plan that requires physical security measures to comply with the physical security requirements of section 33 of the Cannabis Regulations

*The information boxes immediately following this table provide some examples

The proposed site plan

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

Additional site evidence relevant to the proposed changes may need to be provided for review and approval. These may include, but are not limited to:

  • Floor plans
  • Alarm reports
  • Access control logs
  • Camera still-shots (day/night)
  • Sanitation programs

Construction material and equipment specifications

Initiate a licence amendment application and update the following sections:

In the Site Details section, add or remove buildings and rooms as necessary. Add or remove activities being conducted within each room as necessary.

In the Physical Security section: upload all required information including the proposed new 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.

In the Record Keeping section, upload a Change to Cannabis Licence Attestation form describing the changes.

Change to the conditions on the licence

Varies depending on the condition. Changes to a condition may require one or more of the following before receiving approval:

  • Supporting documentation
  • Site evidence

On-site inspection by Health Canada

Initiate a licence amendment application and upload a Change to Cannabis Licence Attestation form under the Record Keeping section that clearly outlines the desired modifications. Health Canada will contact licence holders for additional information as necessary.

Important: The Site Details section of every application must accurately reflect all buildings, rooms and activities previously approved by Health Canada, as well as any buildings, rooms and activities being added or removed as a part of the application. If the information in this section does not match Health Canada's records, or the information provided on the Change to Cannabis Licence Attestation form, there will be a delay in processing the application and the licence holder may be asked to withdraw it in order to make corrections.

Important: Analytical testing or research licences cannot be applied for through an amendment to an existing cannabis licence, nor can a new commercial cannabis licence be added to an analytical testing or research licence through an amendment. Licence holders wishing to apply for these licences must submit a new licence application.

Requests to become a holder of a cannabis drug licence (CDL) cannot be made through the CTLS. CDL application forms are available on the Health Canada website. Completed CDL application forms, as well as general questions related to analytical testing licences, research licences and CDLs, can be emailed to hc.sp-licencing-cannabis-licences-sp.sc@canada.ca.

When a licence holder is proposing a change to the site plan, they must first determine whether the proposed change requires physical security measures to comply with the Cannabis Regulations. If it does, a licence amendment application requesting the change must be submitted through the CTLS and approved by Health Canada before the licence record can be updated to reflect the change.

If the proposed changes do not require physical security measures, it is considered a change requiring notification (see section 5.3 of this guide).

Examples of site plan changes that could require physical security measures include:

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

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

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

Health Canada reviews licence amendment applications for site plan changes that require physical security measures as per the requirements in the Cannabis Act and its Regulations. The Cannabis Licensing Application Guide as well as the Physical Security Measures Guide for Cannabis provide more information. If all the requirements are met, the application is approved in the CTLS, the licence record is updated to reflect the change and an amended licence and/or a letter approving the change(s) is issued to the licence holder.

Tip: Authorized activities vary depending on the class or subclass of a 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, as synthesizing cannabis is not an authorized activity under a micro-processing licence. Rather, the licence holder must apply for a new licence to be a standard processor.

Tip: 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 or changes requiring approval or notifications. The Cannabis Regulations specify the licence holder requirements for these.

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, and Health Canada will provide further instructions based on the context.

Tip: 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 notification to Health Canada

As per section 34 of the Cannabis Regulations, some changes require the licence holder to notify Health Canada rather than obtain approval from Health Canada. In these cases, the licence holder must notify Health Canada within five calendar days of making the change. Changes that require notification are defined in section 34 of the Cannabis Regulations and are summarized in Table 3: Changes Requiring Notification to Health Canada. To submit a notification, send an email with the supporting documentation listed in Table 3, and the Notification Attestation Form (see Appendix C) to HC.licensing-cannabis-licences.SC@canada.ca with the subject line: s.34 Notification - Corporation Name - Licence #.

Notifications as well as general inquiries related to analytical testing, research and cannabis drug licences should be sent to hc.sp-licensing-cannabis-licences-sp.sc@canada.ca.

Important: To replace the responsible person, licence holders should submit the notification to Health Canada through a licence amendment application in the CTLS. See Table 4: Changes to the responsible person for instructions on how to submit a licence amendment application in theCTLS.

Tip: Other than when changing the responsible person, licence holders are not required to update information in the CTLS related to notifications. Certain information in the CTLS related to a notification, such as a new email address, will be updated by Health Canada following receipt and review of the notification.

Table 3: Changes requiring notification to Health Canada as per section 34 of the Cannabis Regulations (email notification)
Type of change Required supporting documentation
A change to the mailing address, telephone number, email address or facsimile number of the licence holder
  1. A description of the change; and
  2. A Notification Attestation form, signed and dated by the responsible person indicating that all information provided in support of the notification is correct and complete to the best of their knowledge.
A change to the site plan that does not require physical security measures to comply with Part 4 of the Cannabis Regulations
  1. A description of the change; and
  2. A Notification Attestation form, signed and dated by the responsible person, indicating that all information provided in support of the notification is correct and complete to the best of their knowledge.

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

Replacing or adding a Head of Security or Master Grower.

  1. A description of the change;
  2. The name, date of birth and the CTLS User Account ID for each of the new individuals;
  3. If the individual replaced a director or officer, the certificate of incorporation or other amended incorporating instrument of the corporation or cooperative.
  4. A Notification Attestation form, signed and dated by the responsible person indicating that all information provided in support of the notification is correct and complete to the best of their knowledge.
Updates to the organizational security plan for cultivation, processing and medical sales licences
  1. A description of the change; and
  2. A Notification Attestation form, signed and dated by the responsible person indicating that all information provided in support of the notification is correct and complete to the best of their knowledge.
Table 4: Changes to the responsible person
Required information CTLS instructions
The proposed new responsible person's CTLS User Account ID

Initiate a licence amendment application and update the following sections:

In the Licence Ownership section, designate the new responsible person using their CTLS Account ID

In the Record Keeping section, upload a Notification Attestation form describing the change

Note: Only the current responsible person is able to initiate and submit a licence amendment application in the CTLS. If the responsible person is not able to complete this step for any reason (e.g., they left the company abruptly), licence holders must contact Health Canada for assistance

Any individual who is required to hold a security clearance under section 50 of the Cannabis Regulations must hold a valid clearance before assuming the duties of the position. In addition, the licence holder must ensure they have someone in the required positions at all times.

In addition to the notification requirements defined in section 34 of the Cannabis Regulations, individuals who hold security clearances must immediately 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 written notice should be emailed to HC.licensing-cannabis-licences.SC@canada.ca.

Tip: Licence holders are responsible for ensuring that all changes they submit are accurate and meet the legal requirements. They should pay particular attention to changes requiring approval by Health Canada as these changes must be approved by Health Canada before they are implemented.

If a licence holder makes a change that does not comply with the requirements, Health Canada may take compliance and enforcement actions.

5.4 Multiple changes

Licence holders can request multiple changes in one licence amendment application. A summary of the changes must be provided using the Change to Cannabis Licence Attestation form, found in Appendix B. The completed form is to be uploaded in the Record Keeping section of the amendment application.

Important: Applications for an amendment that request multiple changes cannot receive partial approval. Therefore, the amount of time from submission to final approval is dependent on the change that takes the most time to review and approve, as well as the number of changes requested. Licence holders are encouraged to prioritize and group their requests accordingly.

5.5 Amendments triggered by Health Canada

As per section 63 of the Cannabis Act, Health Canada may 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 to the licence holder 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.

5.6 Requests for more information and refusal to issue

In accordance with subsection 62(5) of the Cannabis Act, Health Canada may ask a licence holder to submit additional information related to the application related to the renewal or amendment 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 section 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 provides 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. Health Canada does not return information and data submitted to support an application.

Important: If an application for renewal is refused and the licence expires, the licence holder is no longer authorized to conduct the activities specified in the licence 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 form of cannabis (e.g., oil, seeds, plants) and description of the packaging if applicable

 

 

Name and address of the exporter

 

 

Intended use of the cannabis including a detailed description of what the imported/exported product will be used for

 

 

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 Valid import permit from the competent authority in the country of import -

 

An Import or Export Permit Application for medical or scientific purposes form, as found in Appendix D and Appendix E 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 be found on the Health Canada website.

Tip: 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

Tip: Import and export permit holders are also authorized to, in the case of important, 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 information outlined in sections 209 (for import) and 218 (for export) of the Cannabis Regulations using the cannabis shipment detail notification form, as found in Appendix F. 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 Notification of Shipment or Export Notification of Shipment, as applicable, 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.

Tip: Health Canada may provide information 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 as set out in section 62(7) of the Cannabis Act and as outlined in section 5.6 of this guide.

Sections 206 and 215 of the Cannabis Regulations outline additional reasons that issue an import or export permit may be refused, 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

As per section 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 by emailing 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

Section 36 of the Cannabis Regulations requires 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 found in Appendix G, 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 licence holder may cancel a licence through the CTLS and 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 activities have ceased, the licence holder must submit an updated form to Health Canada using the process outlined above. Further changes could include changes to the address of the location where the records, reports and documents are stored, or a change to the person who can be contacted for more information.

As per 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

Tip: 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.

Section 241 of the Cannabis Regulations requires 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.

Tip: 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 that enables 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

Tip: This requirement only applies to licensed processors.

As per section 244 of the Cannabis Regulations, licensed processors must notify Health Canada of their intent to sell a cannabis product, they have not previously sold in Canada, other than cannabis plants or cannabis plant seeds. This notification must be provided to Health Canada at least 60 calendar days before making the cannabis product available for sale.

A new cannabis product is one that is distinct from other products sold by the processor. For example, cases where a notice of intended sale of a new cannabis product could include a new:

  • cannabis class (i.e., dried cannabis, fresh cannabis, cannabis oil)
  • cannabis product form (e.g., pre-rolled joint, capsule, spray)
  • product that is an accessory that contains cannabis
  • intended use (e.g., inhalation, ingestion, topical)
  • brand name, or alternate brand name
  • THC and CBD concentration and/or quantity per discrete unit and any other cannabinoids, their concentration and/or amount
  • sensory attributes of the product such as the flavour, scent, colour or shape
  • anything else that significantly distinguishes the product (e.g., nano- or biotechnology based product, re-introduced terpenes)

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.notice-cannabis-avis.sc@canada.ca if they are uncertain as to when a proposed new product requires notification to Health Canada.

Important: Notifying Health Canada of a new product does not constitute approval for sale by Health Canada, nor does it mean that the product complies with legislative requirements.

Licence holders should not expect any communication back form Health Canada.

Licence holders are responsible for making sure their cannabis products meet the requirements of the Cannabis Act and the Cannabis Regulations and they comply with any other federal or provincial legislation.

A Notice of New Cannabis Product Form, as shown in Appendix I, should be used to notify Health Canada. One form should be submitted per new cannabis product notification.

As per section 244 of the Cannabis Regulations, the information that must be submitted includes:

  • the cannabis class (as per Schedule 4 of the Cannabis Act)
  • a description of the product including the brand name
  • the date on which the cannabis product is expected to be made available for sale

The description could include any of the key information that would define a new cannabis product as noted above.

Licence holders should submit the information to hc.notice-cannabis-avis.sc@canada.ca. The subject line and the file name should indicate "Notice of New Cannabis Product".

There is no fee associated with the new cannabis product notification process.

Tip: When a licensed processor has conditions on their licence that do not give the processor authority to sell a certain product, "pending amendment to licence to authorize for sale" should be indicated for date of sale on the new product notification. In this case, the licence holder may sell the product once they are authorized to do so and once 60 calendar days have passed since a complete notice of new product was submitted to Health Canada.

Tip: 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, as per subsection 244 (2) of the Cannabis Regulations.

Important: Notice of new cannabis products for edible cannabis, cannabis extracts and cannabis topicals under the proposed amendments to the Cannabis Regulations will not be accepted until the proposed amendments are in force, which will be no later than October 17, 2019. Additional guidance will be provided as it becomes available.

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 purpose of the promotion prohibitions is to protect public health and public safety, including protecting young persons and others from inducements to use cannabis. For more information on promotion prohibitions, refer to the Cannabis Act and The Cannabis Act - Promotion Prohibitions.

As per section 245 of the Cannabis Regulations, all licence holders, including those with research and/or analytical testing licences, are required to provide information about their promotional activities related to cannabis, cannabis accessories or services related to cannabis.

The information that must be submitted includes the total amount of money spent in a given calendar year on promotion, categorized into (1) promotions directed to consumers who purchase cannabis at the retail level in Canada and (2) all other promotions that are not directed to consumers who purchase cannabis at the retail level. The information must also include a description of the types of promotion on which the money was spent.

Tip: "Consumers who purchase cannabis at the retail level" are 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 who purchase cannabis at the retail level could encompass a variety of individuals or companies, such as promotions targeted to health care practitioners.

Licence holders are responsible for ensuring that their report on promotions meets all of the requirements listed under section 245 of the Cannabis Regulations. Large corporate entities holding multiple licences may submit a combined report on behalf of all of their licence holders; however, this document must contain separate reports for each licence number or each brand (i.e., brand element). If an individual or corporation chooses to report their promotions expenses by brand, all licence numbers associated with the brand should be clearly identified, and any non-brand specific promotions also need to be included in the report in order to fully fulfill the requirements listed under section 245 of the Cannabis Regulations.

This information must be provided no later than March 31 of the year following the year when the promotion occurred. Licence holders are encouraged to submit nil reports if no promotional spending occurred to demonstrate compliance with the reporting requirements and to limit the possibility of follow-up requests for information by Health Canada.

Appendix H shows an Annual Reporting Form: Reporting Information Related to Promotions that may be used to submit the information about promotions. Completed reports should be emailed to hc.ctls-bi-sscdl-ie.sc@canada.ca with the subject line 'Promotions Reporting' and the associated licence number or numbers.

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

Tip: 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 takes place as per section 236 of the Cannabis Regulations. Copies of the promotional material can be requested by Health Canada under section 43 of the Cannabis Act.

For more information on requirements associated with the promotions prohibitions and promotions reporting, licence holders are encouraged refer to the Cannabis Act and its Regulations.

Licence holders are invited to contact Health Canada at hc.ctls-bi-sscdl-ie.sc@canada.ca if they have any questions regarding promotions reporting or how to complete the promotions reporting form, with the term "Promotions" in the subject line of the email.

7.6 Other reporting requirements

The Cannabis Act and the Cannabis Regulations include several 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)

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

8.0 Licence Suspensions and Revocations

8.1 Suspension of a licence or permit

Health Canada may suspend a licence under subsection 64(1) of the Cannabis Act or section 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.

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, by emailing HC.licensing-cannabis-licences.SC@canada.ca within 10 days of receipt of the notice. 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

As per section 65 of the Cannabis Act, Health Canada may revoke a licence or permit 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 the licence was issued, 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
  • the 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

Section 31 of the Cannabis Regulations also set out additional reasons revoking a licence such as:

  • the holder of the licence has requested the revocation, in writing
  • the licence has been suspended and not reinstated because the reasons for the suspension still exist or the holder of the licence has not demonstrated to the Minister that the suspension is unfounded
  • since the issuance of the licence, a security clearance in respect of the licence has been refused
  • the holder of the licence no longer holds the cannabis licence issued under subsection 14(1.1) of the Excise Act, 2001, if it is required

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 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. Requests for a meeting or teleconference will be evaluated on a case-by-case basis.

For general questions about the Cannabis Act and its Regulations, outside of a specific application but including those related to the CTLS, email cannabis@canada.ca or contact Health Canada 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 section 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 (section of the Cannabis Regulations) Frequency Form and manner
Notice to local authorities (section35) Within 30 days of licence issuance, amendment, suspension, reinstatement or revocation Email copy of notice to: HC.licensing-cannabis-licences.SC@canada.ca
Notice of cessation of activities (section 36) Within 30 days of intent to cease activities Email Appendix G to: HC.licensing-cannabis-licences.SC@canada.ca
Record of key investors (section 241) Annually, no later than January 31 Email information to: HC.licensing-cannabis-licences.SC@canada.ca
Notice of new cannabis products (section 244) At least 60 days prior to making a new cannabis product available for sale Email Appendix I to hc.notice-cannabis-avis.sc@canada.ca
Reporting information related to promotions (section 245) Annually, no later than March 31 of the year following the year when the promotion took place Email Appendix H to: hc.ctls-bi-sscdl-ie.sc@canada.ca
Organizational security plan (section 45) At Health Canada's request Email updated organizational security plan to HC.licensing-cannabis-licences.SC@canada.ca
Monthly inventory reporting from cannabis licence holders (cultivators, processors and medical sales) No later that the 15th of each month for the previous month Refer to additional guidance documents on reporting requirements and procedures on the Health Canada website.
For other reporting requirements, such as on theft or loss, recalls, and adverse reactions, refer to the Cannabis Regulations and other guidance listed in section 7.6 of this guide.

Appendix B: Cannabis Licence Attestation Form

PDF version (645 KB, 2 pages)

This form must be included as part of all licence amendment applications submitted to Health Canada. The completed form 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.

The attestation form may also be uploaded under the Record Keeping section of licence renewal application by licence holders who wish to make changes to their licence at the time of renewal.

Appendix C: Notification Attestation Form

PDF version (595 KB, 2 pages)

This form must be emailed to Health Canada as notification of a change, as outlined in section 34 of the Cannabis Regulations.

Notifications relating to cultivation, processing, and medical sales licences should be sent to HC.licensing-cannabis-licences.SC@canada.ca

Notifications relating to analytical testing, research and cannabis drug licences should be sent to hc.sp-licensing-cannabis-licences-sp.sc@canada.ca

Changes to the responsible person should be submitted as a licence amendment application in the CTLS with this form being uploaded in the "Record Keeping" section of the CTLS in the application.

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

PDF version (681 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".

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

PDF version (653 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".

Appendix F: Cannabis Shipment Detail Notification Form

PDF version (602 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.

Appendix G: Notice of Cessation of Cannabis Activities Form

PDF version (694 KB, 3 pages)

This form should be used to notify Health Canada of a licence holder's 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".

Appendix H: Annual Reporting Form: Reporting Information Related to Promotions

PDF version (804 KB, 4 pages)

Information reported should only include information for the previous calendar year (January 1-December 31), with the format based on the attached forms below. Once completed, the forms should be emailed to hc.ctls-bi-sscdl-ie.sc@canada.ca no later than March 31. The subject line should contain the heading 'Promotions Reporting' and include the affiliated licence number or numbers. Licence holders are encouraged to submit nil reports if no promotional spending occurred to demonstrate compliance with the reporting requirements. This will limit any follow-up Health Canada may need to undertake in order to confirm this aspect.

Appendix I: Notice of New Cannabis Product Form

PDF version (789 KB, 4 pages)

This form should be used to notify Health Canada of a licensed processor's intent to sell a new cannabis product. The completed form should be emailed to hc.notice-cannabis-avis.sc@canada.ca. The subject line and the file name should indicate "Notice of New Cannabis Product".

As mentioned in section 7.4 of this guide, section 244 of the Cannabis Regulations requires 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 calendar days before the cannabis product is made available for sale.

Notifying Health Canada of a new product does not constitute approval for sale by Health Canada, nor does it mean that the product complies with legislative requirements.

It is the licence holder's responsibility to ensure all of its activities, including those related to new products, comply with the Cannabis Act and Regulations as well as any other federal and provincial legislation.

Footnotes

Footnote 1

Throughout this guide, there are references to actions that would be taken by the Minister under the Cannabis Act and its Regulations, often in the context of decision-making. In many cases, decision-making would not be exercised personally by the Minister, but instead by an official in the Department of Health who is in a capacity appropriate to making the decision and who has been delegated that responsibility in accordance with the Salaries Act.

Return to footnote 1 referrer

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