Cannabis licence management guide: Cultivation, processing and sale for medical purposes

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Organization: Health Canada

Date published: 2018-11-09

Date updated: 2019-08-30

Note: Research and analytical testing licence holders should continue to refer to the version of the guide as released on June 13, 2019. For a copy of this guide please contact us at hc.sp-licensing-cannabis-licences-sp.sc@canada.ca.

Table of contents

Foreword

The Cannabis Act, s. 62, establishes that an application for a licence or permit, or for its renewal or amendment, must be filed with the Minister in the form and manner specified by the Minister and must include the information required by the Minister. This guide sets out the application process including the form and manner for submitting applications for the issuance, renewal and amendment of licences and permits. In accordance with the Cannabis Act, the Minister may also request any additional information that pertains to the information contained in an application and that is necessary to consider it. It is important to note that in the case where any information required to be submitted is not provided, the Minister may refuse to consider an application.

Health Canada is committed to protecting personal information as well as confidential business information that is under its control. Ensuring the confidentiality, integrity, and availability of information is essential to government decision making and the delivery of services and Health Canada recognizes that the protection of this information is an essential element in maintaining public trust in government. Health Canada has a systematic process in place to protect this information including the identification and categorization of information, implementation of appropriate privacy training for personnel and information technology safeguards consisting of restricting access, including the level of access, to information in the Cannabis Tracking and Licensing System (CTLS) to those who need access to perform their duties. There may be instances where personal and/or confidential business information contained in applications made to Health Canada may be disclosed, however only as required or permitted by law.

In addition to protecting your personal information, the Privacy Act gives you the right to request access to and correct your personal information. For more information about these rights, or about our privacy practices, contact the Privacy Coordinator at 613-946-3179 or privacy-vie.privee@hc-sc.gc.ca. You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information has been handled improperly.

Disclaimer:

This document should be read in conjunction with relevant sections of the Cannabis Act and its Regulations. In the case of any discrepancies between this document and the Cannabis Act and its Regulations, the latter shall prevail. In cases of discrepancy between the Cannabis Tracking and Licensing System (CTLS) and the Regulations or guidance, the Cannabis Regulations and this guide should be referred to for the established requirements and terminology.

1.0 Purpose

This document (the "Guide") provides holders of licences authorizing cultivation, processing and sale for medical purposes issued under the Cannabis Act and pursuant to the Cannabis Regulations with information on how to manage their licence after it has been issued, including how to renew their licence, how to amend their licence, and how to apply for an import or export permit, if applicable. 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 on behalf of the Minister after consideration of the application within the framework of 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. This guide provides licence holders with best practices to employ to meet these requirements.

Health Canada has established the Cannabis Tracking and Licensing System (CTLS) as the system through which applicants may apply for licences, amendments, renewals and security clearances and submit tracking reports. Licence holders may also 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 guide applies to those who hold licences for:

  • Cultivation
  • Processing
  • Sale for medical purposes

It does not apply to industrial hemp licence holders under the Industrial Hemp Regulations or analytical testing, research or cannabis drug licence holders under the Cannabis Regulations.

This document provides guidance 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
    • Reporting promotion-related information
    • Annual reporting of key investors
  • Licence and permit refusals, suspensions and revocations

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

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

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 2.0.

Important: 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. Some definitions that appear in the Act or in the Regulations are included in this section for ease of reference, and others appear for the purpose of this guide.

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.
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 ,
  1. cannabis, a cannabis accessory or a service related to cannabis; or
  2. a brand of any cannabis, cannabis accessory or service related to cannabis.
Brand name:
The name, whether or not it 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 extract:
As defined in the Cannabis Regulations means,
  1. a substance produced by
    1. subjecting anything referred to in item 1 of Schedule 1 to the Act to extraction processing, or
    2. synthesizing a substance that is identical to a phytocannabinoid produced by, or found in, a cannabis plant; or
  2. a substance or mixture of substances that contains or has on it a substance produced in a manner referred to in paragraph (a)
  3. It does not include a cannabis topical or edible cannabis

Cannabis plant:
As defined in the Cannabis Act, means a plant that belongs to the genus Cannabis.
Cannabis product:
As defined in the Cannabis Regulations, means cannabis of only one of the classes set out in Schedule 4 to the Cannabis Act - or a cannabis accessory that contains such cannabis - after it has been packaged and labelled for sale to a consumer at the retail level. A cannabis product does not include:
  1. cannabis that is intended for an animal;
  2. a cannabis accessory that contains cannabis that is intended for an animal; or
  3. a drug containing cannabis.
Cannabis topical:
As defined in the Cannabis Regulations, means a substance or mixture of substances that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Act and that is intended for use, directly or indirectly, exclusively on external body surfaces, including hair and nails.
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 or 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
Dried cannabis:
As defined in the Cannabis Act, means any part of a cannabis plant that has been subjected to a drying process, other than seeds.
Edible cannabis:
As defined in the Cannabis Regulations means, a substance or mixture of substances that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Act and that is intended to be consumed in the same manner as food. It does not include dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds.
Fresh cannabis:

As defined in the Cannabis Regulations, means freshly harvested cannabis buds and leaves, but does not include plant material that can be used to propagate cannabis.

Ingredient, as defined in the Cannabis Regulations, means

  1. In the case of a cannabis extract or a cannabis topical, a substance, other than anything referred to in item 1 or 3 of Schedule 1 the Act, that is used to produce the cannabis extract or cannabis topical, including any substance used in the manufacture of that substance, and that is present in the final form of the cannabis extract or cannabis topical.
  2. In the case of edible cannabis,
    1. a substance, other than anything referred to in item 1 or 3 of Schedule 1 to the Act,
      1. that is used to produce the edible cannabis if the use of the substance results, or may reasonably be expected to result, in the substance or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or
      2. that is part of a mixture of substances referred to in item 2 of that schedule that is used to produce the edible cannabis if the use of the mixture results, or may reasonably be expected to result, in the substance or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or
    2. a mixture of substances, other than anything referred to in item 1 or 3 of Schedule 1 to the Act,
      1. that is used to produce the edible cannabis if the use of the mixture results, or may reasonably be expected to result, in the mixture or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or
      2. that is part of a mixture of substances referred to in item 2 of that schedule that is used to produce the edible cannabis if the use of the latter mixture results, or may reasonably be expected to result, in the former mixture or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis.
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:
  1. having provided money, goods or services directly or indirectly to the holder;
  2. 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 information that must be submitted through the CTLS to apply for, change or renew a licence as follows:
  • New licence application: 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 for 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
  • Sale for medical purposes
  • Analytical testing
  • 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

CBD:
cannabidiol
CBDA:
cannabidiolic acid
CTS:
Cannabis Tracking System
CTLS:
Cannabis Tracking and Licensing System
GPP:
Good Production Practices
QAP:
Quality Assurance Person
THC:
delta-9- tetrahydrocannabinol
THCA:
delta-9-tetrahydrocannabinolic acid

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. Refer to section 5.1 in this Guide for information on submitting licence renewals.

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 that can be initiated by a licence holder, as follows:

  • Changes requiring approval by Health Canada (see sections 20, 32 and 33 of the Cannabis Regulations). Refer to section 5.2 in this guide for more information about changes requiring approval.

For the purposes of this Guide, an application for a cultivation, processing or sale for medical purposes licence at an approved licensed site is also considered a change requiring approval.

  • Changes requiring notification to Health Canada ( see section 34 of the Cannabis Regulations). 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 Regulations. Therefore, it is critical that licence holders be familiar with the regulatory requirements and follow the processes as outlined in this guide.
Licence holders are expected to comply with applicable requirements as outlined in the Regulations, and compliance may be verified at any time by Health Canada.

Table 1: Changes related to a licence lists the types of changes that may be made, as well distinguishes between those which require approval and those which require notification and how the changes must be submitted to Health Canada. Some changes only apply to certain licence types (e.g., change of Quality Assurance Person [QAP] only applies to licences for standard processing 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 5.3 of this guide

Submission method

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

 

Email
Change licence holder name

 

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

 

- CTLS
Licence classes and activities Add a new licence class to a licensed site (i.e., cultivation, processing, sale for medical purposes)

 

- CTLS
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

 

- CTLS
Personnel changes Change the QAP

 

- CTLS
Change other individuals who require a security clearance such as corporate personnel or master grower -

 

Email
Change to the responsible person -

 

CTLS
Site changes Change to the site plan that requires physical security measures to be carried out in order to comply with Part 4 of the Cannabis Regulations (e.g., the addition of a grow or operations area, converting a grow or operations area into a storage area)

 

- CTLS
Change to the site plan that does not require physical security measures to be carried out in order to comply with Part 4 of the Cannabis Regulations (e.g., the removal of extra cameras within a room not required by the Regulations or a change in nomenclature for areas on the site plan, converting a storage area to an operations area) -

 

Email
Change an organizational security plan (e.g., updates to the business plan, change in the site organizational chart) -

 

Email
Licence conditions Change the conditions on the licence to authorize a new cannabis class for sale to a provincially or territorially authorized retailer and/or holder of a licence for sale for medical purposes

 

- Email
Other Change concerning good production practices or record keeping practices 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. N/A

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 CTLS can be accessed directly or through the Health Canada website.

A licence renewal application is initiated by navigating to the Licences tab in CTLS and clicking the green arrow icon renew icon next to the licence to be renewed. After pressing confirm, the status of the target licence will change from "Issued" to "Renewal in progress". To review and submit the licence renewal, navigate to the Licence Applications tab in CTLS and click the green pencil icon edit icon next to the newly generated draft amendment application.

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

Licence holders are not required to re-enter information to renew a licence. Health Canada assumes renewals are based on information provided in support of the current licence. Licence holders must, however, confirm that all the information in the CTLS is up to date at the time of the licence renewal. Licence holders should review all information captured in the CTLS to ensure its accuracy prior to the submission of the licence renewal. If information is captured incorrectly in the CTLS, please contact Health Canada at HC.licensing-cannabis-licences.SC@canada.ca.

Prior to renewing a licence, Health Canada may request additional information which may include but is not limited to:

  • names of individuals in key positions at the licensed site
  • corporate organizational chart and the names of directors and officers of the licence holder and parent company, if applicable
  • updated site plan indicating the site perimeter and the names and locations of all buildings within the perimeter
  • updated floor plans of the interior of each building indicating the names and locations of all rooms/areas in which cannabis may be present
  • updated list of rooms within each building and the activities being conducted in each
  • updated Organizational Security Plan
  • Key Investor Report

Note: The names used to identify each room/area in the CTLS must match all other information submitted (e.g., site plan, floor plans).

Important: Licence holders who wish to make changes to their licence when they renew it may do so by initiating a licence renewal application as described above and then following the process(es) outlined in 5.2 Changes Requiring Approval and/or section 5.3 Changes Requiring Notification to Health Canada 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 verifies:

  • the security clearance status of the individuals involved
  • the information in the licence record in the CTLS
  • the status of fees paid, if applicable
  • the status of licences issued under the Excise Act, 2001 (by the Canada Revenue Agency)
  • in the case of a licence for processing, that the licence holder has not been convicted of an offence under the Safe Food for Canadians Act or an Act referred to in subsection 374(2) of the Safe Foods for Canadians Regulations

An inspection may also be conducted to verify ongoing compliance with the requirements of the Cannabis Act and its Regulations. The licence holder may also be asked to provide additional information to help Health Canada plan the inspection.

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 with the exception of an application to amend a licence to add sale of classes of cannabis which must be submitted via email, 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 may be initiated by opening the Licences tab in the CTLS and clicking the green pencil icon edit 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 edit icon next to the newly generated draft amendment application.

Once the application is submitted, the licence holder can no longer view or edit it, and no other changes to the licence can be submitted in the CTLS until Health Canada has reviewed and accepted or refused the application.

A licence holder may check the status of their amendment application in the CTLS at any time.

There are three categories in the CTLS that denote the status of the application as follows:

Submitted: Health Canada has received the application

In Progress: Health Canada has begun the screening or review of the application

Pending Information: A request for more information has been sent and Health Canada is waiting for a response from the licence holder

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 at HC.licensing-cannabis-licences.SC@canada.ca when they change and resubmit an application in the CTLS. Applications that are withdrawn and resubmitted are likely to be subject to processing delays.

Important: Licence holders may be asked to withdraw and resubmit a licence amendment application if the information submitted does not accurately reflect the information in the application (e.g., Application for approval of a change to the site plan [see Appendix J] indicates additional grow rooms but these were not added under the Site Details section of the application for an amendment in the CTLS).

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 applicable form (see Appendix B or J) into the Record Keeping Description section before submitting the application.
Licence holders should ensure that the file name of all documents that they upload to the CTLS indicate 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.

Tip: Personnel changes requiring approval
Licence holders who wish to make personnel changes that require approval (e.g., QAP or alternate QAP), should send an email to HC.licensing-cannabis-licences.SC@canada.ca to identify the proposed new individuals as being linked to the licensed site, as well as identify any individuals who are no longer linked to the licensed site. Licence holders should confirm that they have applied for a security clearance through the CTLS prior to submitting the amendment application. This will allow licence holders to submit other amendment applications in the CTLS as they wait for the security clearance to be granted. Once the individual receives their clearance, an amendment application can be submitted in the CTLS.

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

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

A change to the name of the licence holder (if the licence holder is a corporation, partnership or cooperative).

Note: This triggers an amendment to all licences held by the licence holder.

  • Cannabis Licence Attestation Form (see Appendix B)
  • 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 held by the corporate profile and each application will need to be completed and submitted by the responsible person and approved before a licence with the modified name can be issued.

Update the following sections in the licence amendment application:

In the Licence Holder section: Verify that the licence holder is accurate.

In the Record Keeping Description section: Upload a Cannabis Licence Attestation Form (see Appendix B)

A change to the name of the licence holder (if the licence holder is an individual).

Note: This triggers an amendment to all licences held by the licence holder.

  • Cannabis Licence Attestation Form (see Appendix B)
  • A document that shows the name change, such as the legal name change certificate, or marriage certificate

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 held by the licence holder and each application will need to be completed and submitted by the responsible person and approved before a licence with the modified name can be issued.

Update the following sections in the licence amendment application:

In the Licence Holder section: Verify that the licence holder is accurate.

In the Record Keeping Description section: Upload a Cannabis Licence Attestation Form (see Appendix B)

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.

  • Cannabis Licence Attestation Form (see Appendix B)
  • 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.
  • An updated site survey, if applicable

Initiate a licence amendment application and update the following sections:

In the Site Details section: Modify the address of the site.

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 Site Survey section: If the change in address results in a change to the site survey upload a new or revised site survey (see section 6.4 of the Cannabis Licensing Application Guide: Cultivation, Processing and Sale for Medical Purposes).

In the Record Keeping Description section: Upload a document showing the address change, and a Cannabis Licence Attestation Form (see Appendix B) describing the change.

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

Note: This also includes applying for a cultivation, processing or sale for medical purposes licence at the approved licensed site.

  • Cannabis Licence Attestation Form (see Appendix B)

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 requirements would be met for the proposed change.

Refer to sections 6.8, 6.9, and 6.10 as applicable of the Cannabis Licensing Application Guide: Cultivation, Processing and Sale for Medical Purposes for instructions on the required details to include.

Initiate a licence amendment application and update the following sections:

In the Site Activities section: Indicate any licence classes to be added to the existing licensed site.

Note: Applications to apply for a standard or micro processing licence will only be reviewed if the proposed QAP already holds a valid security clearance. As security clearance application 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 Physical Security and GPP sections upload all required information.

In the Record Keeping Description section, upload a Cannabis Licence Attestation Form (see Appendix B) 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 Regulations)

  • Cannabis Licence Attestation Form (see Appendix B)
  • 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 relevant requirements in Part 5 (good production practices requirements) and Part 6 (cannabis products) of the Cannabis Regulations.

Refer to Table 7 of the Cannabis Licensing Application Guide: Cultivation, Processing and Sale for Medical Purposes for instructions on the required details to include.

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 proposed QAP or alternate QAP with the licence.

In the Quality Assurance Person Qualifications section: Upload the proposed QAP's or alternate QAP's qualifications, proposed work schedule and other supporting information (e.g., resume, transcripts).

In the Record Keeping Description section, upload a Cannabis Licence Attestation Form (see Appendix B) describing the changes.

The following changes to the site plan that require physical security measures to comply with Part 4 of the Cannabis Regulations:

  • Addition of new grow or operations area
  • Modification to an approved grow or operations area
  • Modification to an approved storage area
  • Modification to an approved building in a manner that does not affect the site perimeter
  • Application for Approval of a Change to the Site Plan (see Appendix J) and requested supporting documentation

Initiate a licence amendment application and update the following sections:

In the Site Details section: Add or remove rooms as necessary. Add or remove activities being conducted within each room as necessary.

In the Record Keeping Description section: Upload proposed new site plan with the security measures identified.

In the Record Keeping Description section: Upload the completed Application for Approval of a Change to the Site Plan (see Appendix J).

The following changes to the site plan that requires physical security measures to comply with Part 4 of the Cannabis Regulations:

  • Addition of new building
  • Addition of new storage area
  • Modification to an approved building in a manner that affects the site perimeter
  • Change to the site perimeter
  • Cannabis Licence Attestation Form (see Appendix B)
  • The proposed site plan with security measures identified
  • A description of the changes, including updated information as required to demonstrate how the physical security requirements outlined in the Cannabis Regulations are met.

Refer to Section 6.8 of the Cannabis Licensing Application Guide: Cultivation, Processing and Sale for Medical Purposes for additional information on the required details to include.

  • 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:
    • 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 and GPP sections: Upload all required information including the proposed new site plan with the security measures identified. 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 Description section: Upload the Cannabis Licence Attestation Form (see Appendix B) describing the changes.

Change to amend a licence to add sale of classes of cannabis (e.g., authorization of a new cannabis class for sale to a provincially or territorially authorized retailer and/or holder of a licence for sale for medical purposes)

  • Application to Amend a Licence to Add Sale of Classes of Cannabis (see Appendix I) and requested supporting documentation

An on-site inspection by Health Canada may also be required

Do not submit in the CTLS

When a licence holder is applying to amend their licence conditions to add the authorization of sale of a new class of cannabis products, they must complete Application to Amend a Licence to Add Sale of Classes of Cannabis (see Appendix I). The completed form and all required documentation should be emailed directly to Health Canada at HC.licensing-cannabis-licences.SC@canada.ca.

Licence holders should ensure that the file name of all documents that they include in the email indicate the topic of the document and the date it was submitted (e.g., Certificate of Analysis for lot X, Release SOP). Failing to provide a clear title may result in processing delays.

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 Cannabis Licence Attestation Form (see Appendix B), or Application for Approval of a Change to the Site Plan (see Appendix J), there will be a delay in processing the application and the licence holder may be asked to withdraw it in order to make corrections.

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 activities with cannabis can be conducted in the proposed areas and the licence record will be updated to reflect the change.

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

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: Cultivation, Processing and Sale for Medical Purpose as well as the Physical Security Measures Guide for Cannabis provide more information. If all requirements are met and 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 permitted for the licence class or subclass.
For example, a holder of a micro-processing licence that wishes to synthesize cannabis cannot do so by applying for 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 a cannabis extract or solvent used), 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 after 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 number.

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 this change in the CTLS.

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 (see Appendix C), 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 (see Appendix C), 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 (see Appendix C), 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.

Note: The individuals who have been identified to fill a role listed in s. 50 of the Cannabis Regulations must hold a security clearance prior to occupying the position.

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 (See Appendix C), 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 Description section, upload a Notification Attestation Form (see Appendix C) 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.

Tip: Personnel changes requiring notification
Licence holders who wish to make personnel changes that require notification (e.g., master grower, head of security, directors and officers), should send an email to HC.licensing-cannabis-licences.SC@canada.ca to identify any proposed new individuals as being linked to the licensed site, as well as identify any individuals who are no longer linked to the licensed site. Licence holders should confirm that all new personnel have applied for a security clearance through the CTLS. After the individual receives their clearance, a notification designating them to the position can be submitted by email.

A change to the responsible person cannot be submitted via email and requires the submission of an amendment application in the CTLS. Licence holders should send an email to HC.licensing-cannabis-licences.SC@canada.ca to identify the proposed new responsible person as being linked to the licensed site, and confirm that they have applied for a security clearance through the CTLS. Once the individual receives their clearance, an amendment application can be submitted in the CTLS. This will allow licence holders to submit other amendment applications in the CTLS as they wait for the security clearance to be granted.

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 in the CTLS. A summary of the changes must be provided using the Cannabis Licence Attestation Form, (see Appendix B). The completed form is to be uploaded in the Record Keeping Description section of the amendment application. All other applicable forms (e.g., Appendix J) and required supporting documentation must also be submitted as outlined in section 5.2 of this Guide.

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 for a renewal or amendment. This is sent as a Request for More Information as outlined in the Cannabis Licensing Application Guide: Cultivation, Processing and sale for Medical Purposes.

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 and may refuse to issue, renew or amend a licence under a number of circumstances set out in section 29 of the Cannabis Regulations.

In these cases, Health Canada may send a notice of intent to refuse, either to refuse to consider the application or to refuse to issue a licence. This intent to refuse notice will provide the licence holder with a timeframe within which to respond, after which a decision on the refusal will be made.

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 the cannabis (e.g., extract, 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 for LIC number.

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.

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 import, 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, the permit number and LIC 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 subsection 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 an import or export permit may be refused, including:

  • The applicant does not hold a licence
  • The Minister 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 a notice of intent to refuse, either to refuse to consider an application, or to refuse to issue a permit. This notice will provide the licence holder with a timeframe within which to respond, after which a decision on the refusal will be made.

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 for medical purposes 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, as defined by the Regulations
  • 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 for LIC number.

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 for LIC number.

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 specified 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: Cultivation, Processing and Sale for Medical Purposes.

Section 241 of the Cannabis Regulations requires that licence holders for cultivation, processing or sale for medical purposes 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.
Information 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

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. Please refer to the "Notice of New Cannabis Product Guide" for more information.

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 Fact Sheet: 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. Services related to cannabis include clinics where advice may be provided, or specialized delivery services for cannabis, among others.

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 from Health Canada.

Appendix H shows an Annual Reporting Form: Reporting Information Related to Promotions that may be used to submit 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 to 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 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

Tip: Health Canada has annual reporting obligations to the International Narcotics Control Board. It may request information from 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

Health Canada may revoke a licence or permit under a number of circumstances as set out in section 65 of the Cannabis Act.

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 licence or 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 (section 35) 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 authorized 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 Refer to Notice of New Cannabis Product Guide
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 (sections 34 and 45) At Health Canada's request and within 5 days of making a change to the plan 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 than 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 (120 KB, 2 pages)

This form must be included as part of the licence amendment applications referred to in section 2 of this form. The completed form should be uploaded in the "Record Keeping Description" 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.

Appendix C: Notification Attestation Form

PDF version (412 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 related to cultivation, processing and sale for medical purposes licences should be sent to HC.licensing-cannabis-licences.SC@canada.ca

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

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

PDF version (87 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 and the LIC number.

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

PDF version (617 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 and the LIC number.

Appendix F: Cannabis Shipment Detail Notification Form

PDF version (568 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 the permit number and the LIC number.

Appendix G: Notice of Cessation of Cannabis Activities Form

PDF version (679 KB, 3 pages)

This form should be used to notify Health Canada of a licence holder's intent to cease all cannabis activities authorized by a licence. 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 Cannabis Activities and the LIC number.

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: Application to Amend a Licence to Add Sale of Classes of Cannabis

PDF version (147 KB, 4 pages)

This form should be used to apply for an amendment to add sale of classes of cannabis.

Appendix J: Application for Approval of a Change to the Site Plan

PDF version (595 KB, 6 pages)

This form should be used to apply for the approval of a change to the site plan of the types described in this form.

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 employed in a capacity appropriate to making the decision and who has been delegated that responsibility in accordance with the Salaries Act.

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