Cannabis Licensing Application Guide: Application Requirements and Process to Become a Licence Holder under the Cannabis Act and its Regulations

Available now: To access an updated version of this document that reflects amendments to the Cannabis Regulations that will come into force on October 17, 2019, please visit the new guidance. For a copy of the new analytical testing and research application guides please contact us at cannabis@canada.ca.

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Organization: Health Canada

Publication Date: June 27, 2018
Updated: May 8, 2019
Implementation Date: October 17, 2018

Table of Contents

Foreword

The Cannabis Act establishes that an application for a licence 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 an application for a licence and the information that is required to be submitted. 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, please contact Privacy Coordinator at 613-946-3179 or HC.privacy-vie.privee.sc@canada.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 information on the application requirements to obtain a licence from Health Canada under the Cannabis Act and its Regulations.

2.0 Background

The Cannabis Act and its Regulations provide, among other things, the framework for legal access to cannabis and control and regulate its production, distribution and sale.

The oversight of the cannabis supply chain is a shared responsibility across federal and provincial and territorial governments, municipalities, industry and other stakeholders. One of Health Canada's responsibilities is to provide the licensing and oversight framework for legal production of cannabis. Under this framework, a person is required to obtain a licence issued by Health Canada in order to conduct various activities with cannabis. Applicants and licence holders are responsible for compliance with the Cannabis Act and its Regulations as well as compliance with other applicable federal, provincial and territorial legislation and municipal by-laws.

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

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

3.0 Scope

This document provides guidance to anyone wishing to apply for a licence ("the applicant") under the Cannabis Act and its Regulations to conduct activities in relation to the following classes and subclasses of licences:

  • Cultivation (including licences for micro- and standard cultivation or nursery)
  • Processing (including licences for micro- or standard processing)
  • Sale for medical purposes
  • Analytical testing
  • Research

The following activities are not addressed in this guide:

  • Application for an industrial hemp licence
  • Application for a cannabis drug licence
  • Test kit manufacturing
  • Post-licensing applications including licence amendments and renewals, notifications, and applications for import or export permits
  • Reporting including inventory, recall, and information related to promotions and adverse reaction reporting
  • Applications for registration by an individual to access cannabis for medical purposes as outlined in Part 14 of the Cannabis Regulations
  • Any other items identified as regulatory requirements outside the scope of these specific application requirements

For more information on requirements associated with the activities that are not addressed in this guide, applicants may refer to the Cannabis Act and its Regulations, additional guidance published on the Health Canada website, or contact Health Canada as outlined in section 8 of this guide.

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

Of particular note, Health Canada has established a national cannabis tracking system, referred to as the Cannabis Tracking and Licensing System (CTLS), to enable the tracking of high-level movements of cannabis and to help prevent diversion from and inversion into the regulated supply chain. The system is also used by applicants to apply to Health Canada for a cannabis licence. Applicants should be familiar with the use of this system and should refer to the CTLS User Guide for more information, available upon request from cannabis@canada.ca. This guide is based on the CTLS release 1.2.

Supplemental information, including on cost recovery fees, will be provided by Health Canada when applicable.

Important: In cases of discrepancy between the CTLS and the Cannabis Regulations or guidance, or if the use of the CTLS is not feasible, Health Canada should be contacted for further information. 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 ease of reference.

Cannabis product

As defined in the Cannabis Regulations means, cannabis of only one of the classes that are set out in Schedule 4 to the Cannabis Act — or a cannabis accessory if that accessory contains such cannabis — after it has been packaged and labelled for sale to a consumer at the retail level, but does not include a drug containing cannabis.

Cannabis Tracking and Licensing System (CTLS)

The name of the national cannabis tracking system as referred to in the Cannabis Act, established and maintained by Health Canada to enable tracking of high-level movements of cannabis and to help prevent diversion from and inversion into the regulated supply chain. It is also the system that applicants should use to apply to Health Canada for a cannabis licence.

Key Investor

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

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

Refer to Appendix G: Key investors, for more information.

Local government

As defined in the Cannabis Regulations, includes:

  • an incorporated city, metropolitan area, town, village or other municipality;
  • an authority responsible for delivering municipal services that are related to the activities to be conducted under the licence to an unincorporated city, metropolitan area, town, village or other municipality;
  • a band, as defined in subsection 2(1) of the Indian Act; or
  • a First Nation, Métis or Inuit government that is party to a self-government or land claims agreement that is given effect by an Act of Parliament, or a First Nation, Métis or Inuit government established under a provincial Act.
Organizational security plan (OSP)

An integrated plan that broadly outlines security information and operating procedures. It captures the security risk mitigation measures a licence holder takes to prevent, detect and respond to potential security incidents that could result in the diversion of cannabis to or from the illicit market.

Organizational chart

Visual representation of how authority, responsibility, and information are to flow within a formal organizational structure. It usually depicts different management functions (accounting, finance, human resources, marketing, production, research and development [R&D] etc.) and their subdivisions as boxes linked with lines along which decision making power travels downwards and answerability travels upward. For the purposes of the application, the following two types of organizational charts are required:

Corporate organizational chart (for corporations, cooperatives and partners: Outlining the relationships of directors and officers (if a corporation or cooperative) or partners in a partnership, as well as any individuals, partnerships, cooperatives or corporations that directly control the licence.

Site organizational chart: This chart, which forms part of the organizational security plan, outlines the structure of the licence holder's organization showing the relationships of the management positions within it. For example, in addition to the officers, this chart must identify all persons who are primarily responsible for the following activities or have the following knowledge:

  • any product movement beyond minimal amounts
  • setting operational procedures, including standard operating procedures
  • sensitive security or business knowledge
  • financial controls, including but not limited to the ability to enter into contracts for goods and services
Security clearance
As defined in the Cannabis Regulations means, except in paragraph 53(2)(g) of the Regulations, a security clearance granted by the Minister under section 67 of the Act and includes, for the purpose of paragraph 53(2)(e) of the Regulations, a security clearance granted under section 112 of the former Access to Cannabis for Medical Purposes Regulations.
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

CTLS
Cannabis Tracking and Licensing System
FDA
Food and Drugs Act
GPP
good production practices
OSP
organizational security plan
QAP
quality assurance person
R&D
research and development
RCMP
Royal Canadian Mounted Police
SOP
standard operating procedure

The following icons are used throughout this guide to highlight specific information of interest:

Important: Key or cautionary information, in particular, around data into the CTLS.

Information: Highlights that there may be differences in requirements among licence classes (e.g. different requirements for analytical testing or research).

Tip: Information that could be helpful.

5.0 Application requirements: Getting Started

There are some specific actions that applicants should undertake when creating an application to Health Canada. The CTLS User Guide may be referred to for more information. The process flow outlined in Figure 1 provides a general summary.

Figure 1: Application steps – getting started
Figure 1
Figure 1 - Text Description
  • Step 1: Become familiar with all relevant Federal and provincial, territorial and municipal legislation (section 5.1 of this guide)
  • Step 2: Identify licence class and subclass of interest (section 5.2 of this guide)
  • Step 3:  Create a CTLS Account (section 5.3 of this guide)
  • Step 4:  Inform all required individuals associated with the proposed licence holder to create a CTLS account, and apply for a security clearance, if applicable (section 5.4 of this guide)
  • Step 5:  Create corporate account, if applicable (section 5.5 of this guide)
  • Step 6:  Create an application and gather all information (section 6 of this guide)
  • Step 7:  Submit application (section 7 of this guide)

Tip: The applicant is not required to complete the application process in one session. The application may be started in CTLS and left in 'Draft' status until the applicant is ready to submit it.

5.1 Knowledge areas

When applying for a licence, it is recommended that the applicant be familiar with the knowledge areas outlined below. This knowledge will help the applicant comply with the applicable requirements of the Cannabis Act and its Regulations as well as other federal and provincial or territorial legislation and regulations and/or municipal by-laws.

Table 1: Knowledge areas
Key areas to be familiar with: Notes/References

The Cannabis Act and its Regulations

Links may be found on Cannabis laws and regulations.

Other federal Acts and Regulations

Applicants are responsible for complying with applicable requirements of other Acts and Regulations such as the Food and Drugs Act (FDA), the Pest Control Products Act and the Fertilizer Act, among others.

For some research licences under the Cannabis Act as well as for cannabis drug licences, additional approvals are also required under the FDA and its Regulations.

The Canada Revenue Agency

Depending which activities will be conducted with cannabis, a cannabis licence under the Excise Ac (2001) may also be required. For more information consult the Canada Revenue Agency at:

canada.ca/cannabis-excise

cannabis@cra-arc.gc.ca

1-866-330-3304

Provincial or territorial legislation and regulations, and municipal by-laws

It is the applicant's responsibility to comply with all applicable provincial or territorial laws and regulations (e.g., environmental laws) as well as municipal by-laws (e.g., zoning and building permits).

The provincial or territorial or municipal body may be contacted for more information.

The Cannabis Tracking and Licensing System (CTLS)

Health Canada has established that the CTLS is the primary manner in which licence applications should be submitted. If this is not feasible, applicants may contact Health Canada for more guidance.

Applicants should be familiar with the use of the CTLS. The CTLS can be accessed directly (https://ctls-sscdl.hc-sc.gc.ca/) or through the Health Canada website at http://www.canada.ca/cannabis. For more information, refer to the CTLS User Guide.

The licensing application requirements and process found in this guide

All applicable requirements need to be met in order for a licence to be issued.

Additional Health Canada guidance (e.g., including on promotions, packaging and labelling)

The Cannabis Act and its Regulations include requirements and prohibitions which go beyond the scope of this guide. This includes prohibitions around promotions and requirements for packaging and labelling, among others. It is the responsibility of the applicant to read and understand all the applicable requirements and any associated guidance found on the Health Canada website before applying.

5.2 Determine the type of licence to apply for

Applicants should be familiar with the classes and subclasses of licences to determine which class their activities of interest fall under. Requirements differ based on the licence class or subclass. Appendix B: Cannabis Classes and Subclasses of Licences should be referred to for details on each class and subclass, and Figure 2 can be used as a general reference.

Figure 2: Cannabis classes and subclasses of licences
Figure 2

An industrial hemp licence and a cannabis licence are two other types of licences, but are outside the scope of this guide.

Figure 2 - Text Description
  • If I want to grow cannabis on a large scale, the licence I need to apply for is a standard cultivation licence. This allows me to produce dried, fresh, plants and seeds.
  • If I want to grow cannabis on a small scale (less than 200 square metres), the licence I need to apply for is a micro-cultivation licence. This allows me to produce dried, fresh, plants and seeds.
  • If I want to grow cannabis for starting material (that is, plants and seeds), the licence I need to apply for is a nursery licence. This allows me to produce plants, and seeds in an area that is less than 50 square metres.
  • If I want to make cannabis products on a large scale, the licence I need to apply for is a standard processing licence. This allows me to manufacture cannabis products.
  • If I want to make cannabis products on a small scale (that is, using less than the equivalent of 600 kilograms of dried cannabis in a calendar year), the licence I need to apply for is a micro-processing licence. This allows me to manufacture cannabis products.
  • If I want to sell cannabis for medical purposes, the licence I need to apply for is a sale for medical purposes licence. This allows me to sell cannabis to registered clients.
  • If I want to do testing of cannabis, the licence I need to apply for is an analytical testing licence. This allows me to do any third party testing.
  • If I want to do research with cannabis, the licence I need to apply for is a research licence. This allows me to do research and development with cannabis.
  • An industrial hemp licence and cannabis drug licence are two other types of licences, but are outside the scope of this guide.

Tip: Applicants may apply for any combination of class or subclass of licences in relation to the same site; however, the Minister may refuse to issue a licence, depending on the combinations, in accordance with section 29 of the Cannabis Regulations. Refer to Table 2:  General guide for combinations of licence classes and subclasses at a single site. 

Table 2: General guide for combinations of licence classes and subclasses at a single site
no data Standard Cultivation Micro-cultivation Nursery Standard Processing Micro-processing SaleFootnote 2 Analytical Testing Research
Standard Cultivation N/A N/A N/A Acceptable N/A Acceptable Acceptable Acceptable
Micro-cultivation N/A N/A N/A N/A Acceptable Acceptable Acceptable Acceptable
Nursery N/A N/A N/A N/A N/A Acceptable Acceptable Acceptable
Standard Processing Acceptable N/A N/A N/A N/A Acceptable Acceptable Acceptable
Micro-processing N/A Acceptable N/A N/A N/A Acceptable Acceptable Acceptable
SaleFootnote 2 Acceptable Acceptable Acceptable Acceptable Acceptable N/A Acceptable Acceptable
Analytical Testing Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable N/A Acceptable
Research Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable Acceptable N/A

Important: Although an applicant may wish to apply for multiple licence classes or subclasses at the same site, the CTLS may not currently allow this, depending on the combination of licences sought.  In this case, a separate application may be submitted in the CTLS, or the applicant may contact Health Canada for more information.  

Tip: Licence holders can conduct research and development activities within their authorized licensed activities. If the licence holder wishes to conduct research and development activities outside of their authorized licence activities, they must apply for a separate research licence.

5.3 Create an account in the CTLS

Health Canada has established the CTLS as the primary manner in which licensing applications should be submitted. The first step to create an application is to set up an individual user account in the CTLS (i.e., for the applicant who is the individual or the person who will be setting up the application for an organization). The CTLS Getting Started Guide (available on the Health Canada website) should be referred to for more information on the steps to create an account. To request an account, basic information is required including full name and salutation, email, phone number, date of birth, language preference and security information. Health Canada then provides an access code that can be used to enter the CTLS. Once an account is established, the user will have an Account ID in the CTLS.

Important: Part of the application process requires documents to be uploaded directly within the CTLS. For each section that requires documents to be uploaded, a maximum of 5 documents can be uploaded per section, each with a maximum size of 10MB per document. Applicants should combine documents where suitable and minimize extraneous content in order to submit the required documents. For assistance related to a specific licence application, an email may be sent to: HC.licensing-cannabis-licences.SC@canada.ca. The email must clearly indicate the application file number, the applicant's name and the subject of the correspondence in the subject line of the email.

Tip: Should the CTLS (or internet) not be available, the applicant may contact Health Canada directly by phone at 1-866-337-7705 or by email at cannabis@canada.ca for more guidance.

Information for Indigenous Affiliated Applicants: The Indigenous Navigator Service is designed to help Indigenous affiliated applicants effectively navigate the cannabis licensing process. This service is available to help guide self-identified Indigenous affiliated applicants through each step of the licensing process. Applicants may choose to self-identify in their CTLS application. See section 7.1 Submitting an application for further information. Indigenous affiliated applicants who wish to utilize the support of the navigator service should contact Health Canada at navig@canada.ca prior to submitting their application within CTLS.

5.4 Associated individuals create accounts in the CTLS

User accounts are required for a number of individuals associated with an application. These individuals must create their own individual accounts in the CTLS before an application can be submitted to Health Canada. Individuals can use the same account information for each licence application that they may be associated with. Refer to Table 3: Individuals to be identified.

Important: The CTLS requires that individuals who require a security clearance submit their security clearance application form before a licence application can be submitted in the CTLS. As such, the applicant may wish to have these individuals obtain their criminal record checks and apply for their security clearance, if applicable, as soon as is feasible. A licence will not be granted unless required security clearances have been granted. For information on application requirements related to personnel security clearances, refer to Appendix C: Personnel Security Clearance Application Requirements.

The applicant must ensure that the persons identified have the knowledge, qualifications, experience and ability to fulfill their responsibilities, as applicable. For more information on these elements, refer to Appendix A: Key individuals.

Tip: The applicant should create a list of all Account ID's of individuals associated with an application. Account ID's are used to link individuals to an application in the CTLS. 

Tip: An individual may hold one or multiple roles within the company, for one or more classes of licences at one site, or in some cases, multiple sites, assuming they meet all the requirements.

Important: The CTLS requires at least one director or officer be named per corporate profile.  In the case where there is no director or officer for the organization, the responsible person should be identified as an officer in this section of the CTLS. 

Table 3: Individuals to be identified
Role Account ID's required Security clearance application required prior to submitting application

Directors

For all licence classes if the applicant is a corporation or a cooperative

Yes (for all except research and analytical testing)

Officers

For all licence classes if the applicant is a corporation or a cooperative

Yes (for all except research and analytical testing)

Partners

For all licence classes if the applicant is a partnership

Yes (for all except research and analytical testing)

Licence holder (where holder is an individual)

For all licence classes

Yes (for all except research and analytical testing)Footnote 3

Responsible person

For all licence classes. Note: this can be the individual who is the licence holder

Yes (for all except research and analytical testing)Footnote 3

Head of security

For cultivation, processing or sale for medical purposes licence only

Yes

Master grower

For cultivation licence only

Yes

Quality assurance person(QAP)

For processing licence only

Yes

Head of laboratory

For analytical testing only

No

Any individual, partnership (partners), corporation (directors and officers), or cooperative (directors and officers) in a position to directly control the applicant (For additional information refer to Appendix H: Direct control)

For all licence classes, except research and analytical testing

Yes(for all except research and analytical testing)

5.5 Create a corporate profile for organizations (partnership, cooperative or corporation)

Important: The CTLS does not have a distinct section for organizations such as partnerships or cooperatives. In these cases, the "Corporate Profile" section must be used in the CTLS to provide the information required in this guide about the organization. In the "Other Registered Names" section of the CTLS corporate profile section, the applicant must clearly indicate whether they are a corporation, partnership, or cooperative.

Applicants that are partnerships, cooperatives, and corporations (in essence any applicant that is not an individual/sole proprietor) also need to create a corporate profile. Once a corporate profile is created, the individual who creates the corporate profile will have access to an Account ID for the corporation. When creating a corporate profile, the applicant lists and links (using their respective Account IDs) all the directors and officers of the corporation or cooperative, and the partners if a partnership. Once a corporate profile is created in the CTLS, the applicant can use that profile to create an application.

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

Table 4: Corporate profile requirements
Requirement Required details to include

The full legal name(s) of the organization

Any other name(s) registered federally or provincially under which the entity intends to do business, if applicable.

The incorporation number

As provided on the certificate of incorporation. In the case of a partnership or cooperative, if there is not an identification number, indicate "Not applicable".

Business address and contact details

The business address and the contact details used for correspondence with the corporation, not the individual applicant (e.g., head office).

Controlling organizations (noted as "Parent Corporation" in the CTLS), if applicable

The Account ID of each controlling organization. Note that any controlling organization will be required to create a corporate profile as per these requirements.

Refer to Appendix H: Direct control for more information.

Certificate of incorporation (or partnership agreement)

As part of an application, certificate of incorporation documents are required. In the case of a partnership or cooperative, a partnership/cooperative agreement is required.

Organizational chart

As part of submitting an application, a corporate organizational chart is required. The organizational chart:

  • Must demonstrate the relationships between senior positions within the organization and the various controlling individuals or entities, if applicable.
  • Must include all names and titles of senior management positions such as directors and officers of the organization and any controlling individual or entity, if applicable. Does not need to include the site-specific organizational information (e.g., the site head of security, master grower, QAP). This specific organizational information is required as part of a specific application and is to be included in the OSP.

Organization personnel

As part of an application, specific organization personnel must be identified. These individuals must have individual CTLS accounts created so that their Account IDs can be associated with the corporate profile.

Directors or officers of corporations or cooperatives, and partners in a partnership must be included as part of the corporate profile.

Important: The CTLS does not have a specific section for partners in the case of a partnership. These should be included in the officers section.

Important: As noted earlier, where there is no director or officer for the organization, the responsible person should be identified as an officer in this section of the CTLS.

Health Canada considers any officers of a corporation named on incorporation documentation (e.g., certificate of incorporation), such as the chief executive officer, the chief operations officer and the chief financial officer (or officers equivalent in responsibility), as officers who require a security clearance. It is the responsibility of the applicant to identify all officers and directors of an organization accurately.

Prior to submitting an application in the CTLS, these individuals will also be required to submit an application to obtain a security clearance in the CTLS.

In addition, all officers, directors, partners and individuals who control the applicant must be identified and will require security clearances.

Consult the Cannabis Regulations for details regarding security clearance requirements.

Tip: Before an application is submitted, the corporate profile can be changed. Once an application is submitted, changes are not permitted in the CTLS. Refer to section 7.3.3 Changes to an Application/ Unsolicited Information for more information.

6.0 Application requirements: Creating an application

This section of the guide includes the application requirements that are required for each class of licence. The requirements in this section are categorized by "Requirement Areas" which are found in the CTLS.

All applications are strictly and thoroughly reviewed by Health Canada against the application requirements outlined in this guide.

Applicants are expected to comply with applicable requirements as outlined in the Regulations, and compliance may be verified at any time by Health Canada. Licences may be issued once all applicable requirements are met.

Information for Processing, Cultivation and Sale for Medical Purposes with Possession Licences: In addition to documents submitted as a part of a CTLS application, applicants are required to submit a site evidence package with visual evidence to demonstrate the completion and functionality of their facility. Applications will only be processed once both the document portion of the application is submitted within the CTLS and the site evidence package is submitted and received by Health Canada. Instructions for how to submit a site evidence package are found in section 7.1.1 Submitting Site Evidence.

When creating a new licence application in the CTLS, the applicant must first identify the licence class they are applying for in the CTLS. The licence classes within the scope of this guide include:

  • Cannabis licence class (cultivation, processing, sale for medical purposes)
  • Research
  • Analytical testing

Refer to Appendix B: Cannabis licence classes and subclasses for more information.

Tip: As noted earlier, applicants may apply for more than one class or subclass of licence at the same site depending on the licence class or subclass. For example, applicants may apply for a cultivation, processing and sale for medical purposes licence in one application. However, the design of the CTLS requires a separate application be submitted for analytical testing and research licences. 

Important: This guide establishes the application requirements to obtain a licence. It is up to the applicant to confirm that all application requirements set out in this guide are submitted with the application. This guide also provides details on how to submit this information into the CTLS and, if required, how to submit a site evidence package, directly to Health Canada. Table 5 outlines the relevant sections of this guide where required information must be submitted to Health Canada, according to licence class.

Tip: When the applicant uploads a document into the CTLS, or submits the site evidence package (if required) the file names should clearly identify the name of the application requirement outlined in this guide. For example, Site Survey, OSP, Security Reports.

Table 5: Application Guide Sections with Required Information in the CTLS, by Licence Class
Guide section Requirement area Cannabis Licence Class
Cultivation (Micro, Standard, Nursery) Processing (Micro, Standard) Sale for medical purposes (with possession of cannabis) Sale for medical purposes (without possession of cannabis) Analytical testing Research
6.1 Proposed licence holder (licence ownership) Required Required Required Required Required Required
6.2 Mailing address Required Required Required Required Required Required
6.3 Licence class and subclass (identified as "site activities" in the CTLS) Required Required Required Required N/A N/A
6.4 Site details (including activities) Required Required Required Required Required Required
6.5 Site personnel Required Required Required Required Required Required
6.6 Site ownership Required Required Required N/A N/A N/A
6.7 Notice to local authorities Required Required Required N/A N/A N/A
6.8 Physical security (including organizational security plan) Required
Additional visual evidence to be submitted outside CTLS
Required
Additional visual evidence to be submitted outside CTLS
Required
Additional visual evidence to be submitted outside CTLS
Required
Only organizational security plan is required

Required Organizational security plan not required
Required
Organizational security plan not required
6.9 Good production practices(GPP) Required
Additional visual evidence to be submitted outside CTLS
Required
Additional visual evidence to be submitted outside CTLS
Required
Additional visual evidence to be submitted outside CTLS
N/A N/A N/A
6.10 Record keeping (and reporting) Required Required Required Required Required Required

Important: For a sale for medical purposes licence where there will be possession of cannabis, after selecting the licence class and subclass, the applicant should select "Site Details" and in the "room activity" area of the CTLS, add "sale with possession of cannabis." This opens the additional requirement sections in the CTLS.

6.1 Proposed licence holder (licence ownership)

An application can be created for an individual or an organization. If an applicant is an organization, they must ensure that they have completed a corporate profile for the organization in the CTLS as outlined in section 5.5.

A responsible person must be designated for all applications. The responsible person has the authority to bind the licence holder, has overall responsibility for the activities conducted and is responsible for submitting the application. The responsible person is the official point of contact with Health Canada. Refer to Appendix A: Key Individuals for more information.

Tip: As per the Cannabis Regulations, the applicants may designate one individual as an alternate responsible person who is qualified to replace the responsible person. However, only one responsible person may be designated within the CTLS. To change the responsible person after an application has been submitted, an email should be sent to HC.licensing-cannabis-licences.SC@canada.ca, with the subject line: "Request to change responsible person" and along with the application number and details. Health Canada will contact the applicant for additional details.

6.2 Mailing address

The mailing address entered must be the Canadian address where the applicant would like to receive official mailed correspondence (e.g., the licence when issued).

Tip: This is not necessarily the same as the site address or corporate address.

6.3 Licence class and subclass (identified as "site activities" in the CTLS)

The applicant must select the licence classes and subclasses for which they are applying.

Information: For analytical testing and research licences, this section does not need to be filled out in the CTLS as this information is already identified when initially creating a new application.

Important: Although there is an option in the CTLS to select "Sale Non-Medical Online," this should not be selected.

Tip: As noted in Section 5.2, licence holders can conduct research and development activities within their authorized licensed activities. If the licence holder wishes to conduct research and development activities outside of their authorized licence activities, they must apply for a separate research licence.

6.4 Site details (including activities)

There is certain information required for a site. Requirements differ depending on the licence class (e.g., analytical testing and research requirements differ). Tables 6, 7 and 8 show the different classes of licence, namely cultivation, processing, sale for medical purposes, analytical testing, and research licences.

Information: Licensed activities cannot beconducted in a dwelling-house (i.e., a place of residence).

Important: Licences are site specific with the exception of research, which can have multiple sites set out in a licence. If an applicant, other than an applicant for a research licence, intends to conduct licensed activities at more than one site, a separate application must be submitted for each site.

Table 6: Site detail requirements for cannabis licence class (cultivation, processing, sale for medical purposes)
Requirement Required details to include

Complete site address

Include Canadian address as well as latitude and longitude.

Important: The CTLS allows for entry of a single address in relation to a site. Should the site have multiple addresses (e.g., several buildings in an area used exclusively by the licence holder), all site details as outlined in this section must be uploaded into the CTLS as a separate document titled Additional Site Details. This must be uploaded in the "Site Survey" section of the CTLS.

Site survey

A building location survey, location certificate or similar document, prepared and certified by a person qualified to do so in the jurisdiction where the site is located, such as a qualified land surveyor. The survey must be up to date at the point of submission.

Aerial view

A clear and legible aerial view of the proposed site and surrounding lots to within 500 metres. The aerial view must be up to date at the point of submission.

Production capacity
(Not required for sale for medical purposes)

An estimate of the proposed annual production amount (e.g., kg per year, number of plants or seeds per year) for each applicable cannabis class as found in Schedule 4 of the Act.

The total combined area (m2) of the grow areas and the total combined area (m2) of the operations areas excluding grow areas that are being proposed for licensing. For the grow areas, the total combined area should include all surface areas, taking into account if multiple surfaces are being utilized (e.g., vertically arranged).

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Site Survey" section.

Areas (buildings and rooms, outdoor areas) and activities

Each outdoor area (if applicable), and indoor area (building or part of building) including rooms must be named and this name must be provided. The names used to identify each area must match all other information submitted (e.g., on the site plan). All activities conducted in each room must also be identified (e.g., propagation, drying, labelling, etc.). There is no requirement to identify areas and rooms in CTLS in which no activities with cannabis will take place (e.g., lavatory) or transitory areas (e.g., hallways). However, these areas and rooms should still be identified on the floor plan(s).

More than one activity can occur in each area. Additional information may be requested to assess how the proposed activities meet all regulatory requirements.

Important: These site details are also considered part of the site plan and must match all information provided to meet the requirements detailed in section 6.8 of this guide related to physical security.

Important: As noted earlier, for a sale for medical purposes licence where there will be possession of cannabis
The applicant should first select "Site Details" and in the "room activity" area of CTLS, add "sale with possession of cannabis." This will open the additional requirement sections in the CTLS. All rooms where cannabis is present must be included and room details must be provided.

Information: Each site must have at least one indoor area (building or part of a building).

Cultivators may also have outdoor areas to cultivate, propagate or harvest cannabis.

Table 7: Site detail requirements for analytical testing licence class
Requirement Required details to include

Complete site address

Include Canadian address.

Analytical testing processes to be conducted

Identify the purposes of all analytical testing activities that the applicant is proposing to conduct:

For example, testing for:

  • Chemical (i.e., contaminants such as heavy metals, foreign matter)
  • Microbial (i.e., contaminants such as yeast, molds, bacteria, aflatoxins)

Note: Sterility will appear as an independent item in the CTLS, however it is typically captured in the context of microbial testing.

  • Cannabinoid content (e.g., delta-9-tetrahydrocannabinol [THC], delta-9-tetrahydrocannabinolic acid [THCA], cannabidiol [CBD], and cannabidiolic acid [CBDA])
  • Dissolution/Disintegration
  • Pesticides
  • Solvent residue
  • Sterility
  • Stability (e.g., if the licence holder proposes to include a product expiry date, disintegration test for capsules)
  • Other (e.g., seed viability testing)
Table 8: Site detail requirements for research licence class
Requirement Required details to include

Complete site address

Primary Canadian site at which the research is proposed to occur.

Research grant

The grant number may be provided as additional information, if applicable.

Cultivation

If cannabis is proposed to be cultivated, propagated or harvested, provide information on where it is proposed to be cultivated, propagated or harvested (latitude/longitude, indoor/outdoor).

Synthesis of cannabis

Indicate whether cannabis will be synthesized.

Additional sites

If there are additional sites where activities with cannabis are proposed to occur (e.g., clinical trial conducted at multiple sites), provide the address of each site as well as the name and contact information of an individual at each site. The address of each additional authorized site will appear on the licence, if it is issued.

Intent to sell

Indicate if there is intent to sell the product of the research (e.g., cannabis plants and/or cannabis plant seeds to a licensed cultivator, researcher, cannabis drug licence or exemption holder).

Type of research

Indicate the type(s) of research (e.g., in vitro, in vivo (animal), clinical trial, plant genetics, cannabis product development, non-cannabis product development, other) that is proposed to be conducted with cannabis. An example of non-cannabis product development would be research on lights used to grow cannabis plants. Synthetic cannabinoid development should be included as "Other" and details should be included in the Research Protocol section (see below).

Research protocol

A document outlining the research that is proposed to be conducted, and the quantity of cannabis that is proposed to be possessed or produced by the applicant (e.g., kilogram, litre or number of plants or seeds as appropriate) must be provided. This must also include the duration for which the research licence is sought (up to five years).

For an in vivo (animal) study: FDA authorization, if applicable

For an in vivo study where FDA authorization is required, the Experimental Study Certificate must be submitted as part of the licence application.

Additional information on the Experimental Study Certificate can be found in the Experimental Studies Certificate Application Form for a Veterinary Drug.

For a clinical trial: No objection letter for a clinical trial

For a clinical trial, the applicant must first obtain a no objection letter from Health Canada or an acknowledgement email from the Office of Clinical Trials which must be submitted as part of the licence application. Additional information on clinical trial application requirements can be found in the Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications as well as on the Health Canada website.

Tip: To meet the needs and circumstances of researchers, applications can be submitted with:

  1. One research licence per protocol, per site
  2. One research licence per protocol for multiple sites (e.g. a clinical trial at numerous hospitals)
  3. One research licence for multiple research protocols for one site (e.g. numerous researchers or projects at a single university)

A research licence is granted for a specific research project. A research licence may be effective for the duration of the research project up to a maximum of five years. If the research project needs to continue past the expiry date of the licence, the licence holder may apply for a renewal of the licence. More than one type of research may be conducted under a single licence. The research protocol must describe all types of research to be conducted.

Tip: Depending on the type of activities proposed to be conducted with cannabis and the quantity of cannabis on-site, additional security measures may be required, such as security clearances of key personnel. The licence may also be subject to additional conditions, such as the need for an OSP or increased physical security measures. Each submission will be assessed on a case-by-case basis.

6.5 Site personnel

As outlined in section 5.4 of this guide, as part of the application the applicant should identify individuals that must have accounts and security clearances. The individuals will differ based on the licence class or subclass as well as the type of licence holder (i.e., if it is an individual or a corporation, cooperative or partnership). These individuals should create CTLS accounts and provide their Account IDs to the applicant. Some of these individuals need to be identified if the applicant is creating a corporate profile. Other individuals need to be identified within the "Site Personnel" section of the CTLS. The applicant must ensure that the persons identified have the knowledge, qualifications, experience and ability to fulfill their responsibilities, as applicable. For more information, refer to Appendix A: Key Individuals.

Tip: Qualifications are only required to be submitted for the QAP (and alternate QAP, if applicable) for a processing licence, and the head of laboratory (and alternate, if applicable) for an analytical testing licence.

Tip: An individual may hold one or multiple roles for a licence, for one or more classes of licences at one site, or in some cases, multiple sites, assuming they meet all the requirements.

Important:

For cultivation, processing and sale for medical purposes licences: The CTLS requires that a security clearance application form be submitted for at least one individual in each position that requires a security clearance.

In the case where an applicant wishes to designate an alternate, as authorized under the Regulations, this may be done at any time. However, any alternate must also hold a valid security clearance, as applicable, before assuming the duties of the position. The Minister may also specify other individuals that must hold a security clearance, either by name or position. Should this occur, the licence holder or applicant is notified in writing.

Table 9: Site personnel requirements
Requirement Required details to include

Identification of personnel

Specific individuals must be identified that are associated with an application in the CTLS as follows:

Cultivator (standard, micro or nursery): Head of security, alternate head of security if applicable; master grower, alternate master grower if applicable

Processor (standard or micro): Head of security, alternate head of security if applicable; QAP, alternate QAP if applicable

Sale for medical purposes: Head of security, alternate head of security if applicable

Analytical testing: Head of laboratory, alternate head of laboratory if applicable

Research: None

The responsible person must be identified within the "Licence Ownership" section of the CTLS as noted in section 6.1 of this guide.

To associate these individuals with an application, their Account IDs need to be included in the CTLS.

Important note for researchers:  The CTLS asks for an authorized person; however, this is not required for research licence applications. Only the responsible person should be provided. In addition, the CTLS asks for qualifications for the responsible person, although these are not required for a research licence application. A blank document needs to be uploaded into the CTLS indicating that these are not required.

Qualifications for the QAP (Processing licence only)

Submit details of the proposed individual's qualifications, and any proposed alternate QAP, along with an explanation of how their training, experience and technical knowledge relate to the requirements in Part 5 (GPP requirements) of the Cannabis Regulations including:

  • Development and approval of SOPs
  • Pest control management and pesticide testing
  • Quality control relating to storage and shipment of substances
  • GPP as they pertain to facilities (including air filtration), equipment, sanitation and employee hygiene and protection
  • Complaint management and investigation
  • Approving product quality prior to release for sale
  • Analytical testing and validation of testing methods
  • Residues of solvents (for cannabis oil), if applicable
  • Microbial and chemical contaminants
  • Disintegration/dissolution of cannabis capsules, if applicable
  • Cannabinoid content (THC, THCA, CBD and CBDA, as applicable)
  • Sample collection and retention

In addition, the QAP typically handles recalls and adverse reaction reports

Include clear, concrete examples and details of how the QAP and any alternate meets the technical knowledge, training, and experience requirement, including when, where and how the knowledge, training and, experience was obtained.

The applicant should also submit the QAP's and any alternate's resume and any other information that supports their qualifications such as a letter of reference or a copy of their diploma, degree, certificate or transcripts that may be applicable.

A proposed work schedule and a summary of the roles and responsibilities of the QAP and any alternate if applicable (including if they are employed as a QAP at another licensed site) should also be provided to demonstrate how the QAP will be able to complete all the required activities to maintain compliance.

Tip: For more information regarding the roles and responsibilities of the QAP and any alternate refer to the Good Production Practices Guide for Cannabis.

Qualifications for the head of laboratory
(Analytical testing licence only)

Submit details of the individual's qualifications, and any designated alternate head of laboratory, as they relate specifically to the duties of the position.

  • The applicant should submit proof of the individual(s)' education, such as a copy of their degree, their resume, and any other information that would be relevant such as a letter of reference, or a copy of their university transcripts.

6.6 Site ownership

Information: This section does not apply to analytical testing, research or sale for medical purposes without possession licences.

The following information is required to confirm site ownership:

Table 10: Site ownership requirements
Requirement Required details to include

Site owner

If the site is owned by the individual or the corporation applying for the licence, this must be indicated by linking the Account ID in the CTLS.

If the site is owned by another individual(s) or corporation, a site owner consent form is required (see section below).

Site owner consent form (if the site or any portion of the site is not owned by the applicant)

A declaration, signed and dated by the site's owner— or, if the owner is a corporation, by an authorized representative of the owner — consenting to activities with cannabis being conducted at the site.

The consent form must contain:

  • the full address of the site or any portion of the site for which the owner is not the applicant
  • the class and subclass if applicable of the licence being applied for
  • the proposed activities to be conducted on-site
  • a declaration signed by all owners of the site stating that they:
    1. are the owner(s) of the site, as described
    2. are fully aware of the activities with cannabis that the applicant proposes to conduct at the site
    3. consent to those activities with cannabis being carried out at that site

6.7 Notices to local authorities

Information: Notice to local authorities is not required for analytical testing, research and sale for medical purposes without possession licences.

Prior to submitting an application in the CTLS, applicants for licences to cultivate, process and sell for medical purposes (with possession of cannabis) must provide with their application a copy of the written notice to local authorities who are located in the area of the proposed site, as part of their application.

More specifically, 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(RCMP) that is responsible for providing policing services to that area

The content of the notice must include:

  • the name of the applicant
  • the expected date on which the applicant will submit the application to Health Canada
  • the class and subclass if applicable of licence that is being sought and the cannabis-related activities that are expected to be conducted under that licence
  • the site address (and address of each building on site, if applicable) at which the applicant is expecting to conduct cannabis-related activities

In order to submit an application, the following information is required:

Table 11: Notice to local authorities requirements
Requirement Required details to include

Notice to local authorities

The date each notice was sent or provided, and the name, title and address of the senior official to whom it was addressed.

A copy of the actual notices provided to:

  • 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

6.8 Physical security (including organizational security plan)

Requirements for physical security apply to all licence classes, but differ depending on the licence class, and subclass if applicable. For instance, an OSP is not required for analytical testing and research licences. For more information on the required physical security measures, refer to the Cannabis Regulations and The Physical Security Measures Guide for Cannabis.

Tables 12, 13, 14, and 15 provide summaries of the information that must be submitted as part of the licence application by licence class to demonstrate how the organizational security plan requirements and physical security requirements under the Cannabis Regulations will be met.

Information: The nomenclature of the site and floor plans must be consistent with the information submitted in the "Site Details" section of the CTLS (i.e., for outdoor areas and indoor areas including rooms) and the information submitted with the security reports and visual evidence in the site evidence package.

Table 12: Organizational Security Plan Requirements for Standard Cultivation, Standard Processing, Micro-processing, Micro-cultivation, Nursery and Sale for Medical Purposes Licences
Requirement Required details to include

Organizational security plan

An OSP must be submitted that includes the information detailed below.

1) Head of security: In addition to the information already provided about the head of security (name, contact information), a proposed work schedule including hours of work, as well as a phone number where the head of security can be reached in case of emergency must be provided. The same information for any identified alternate head of security must also be provided.

2) Business Plan: A description of the business model indicating the activities and products that the applicant intends to conduct or sell. Additionally, indicate any affiliations or relationships to other companies.

3) Site organizational chart: A chart outlining the structure of the organization showing the relationships of the officers and management positions within it, including supervisors, must be provided. The chart should include the titles and the names of all individuals who require a security clearance as well as any other positions that have significant influence on strategic business decisions, day-to-day operations and the movement of significant amounts of money or cannabis. For example, this chart must identify all persons who have management responsibility for the following activities or have the following knowledge:

  • any product movement of a significant amount in relation to the overall operations of the facility
  • setting operational procedures, including SOPs
  • responsibility for inputting data into the CTLS for cannabis tracking purposes
  • sensitive security or business knowledge
  • financial controls, including but not limited to the ability to enter into contracts for goods and services.

A description of the roles of each position indicated in the organizational chart must also be submitted.

4) List of individuals in key positions and security status: A list of all proposed individuals in key positions (those identified in the corporate profile and key individuals as described in section 5.4 and Appendix A: Key Individuals), as well as any proposed alternate individuals indicated as such, including their names, date of birth, positions, Account IDs and security clearance application number as applicable.

For an organization: A list of all officers, directors, partners and any individual who exercises, or is in a position to exercise, direct control over the corporation, cooperative or partnership as identified in the organizational chart, including their names, date of birth, positions, Account IDs and security clearance application number as applicable.

Other individuals or positions: Indicate whether there are other proposed individuals or positions that the applicant believes should hold a valid security clearance due to the nature of their work and possible security risks to the organization. For example, the applicant may want to propose security clearances for positions/individuals that have unsupervised or uncontrolled access to sensitive records and information, information technology infrastructure, or access card records (e.g., those identified in the site organizational chart). Note that it is not a requirement to identify additional positions/individuals, but this could be considered by the applicant as a means to mitigate identified security risks. Information including other individuals' name, position title and nature of the position should be provided.

5) Cannabis tracking: A list of all names, titles and contact information for all individuals in the organization who will input data into the CTLS for cannabis tracking purposes must be provided.

6) Security awareness and training: A description of the steps that the proposed head of security intends to take to ensure that guests and all employees/contractors of the site are trained and aware of security requirements and procedures, including:

  • initial training and awareness for all new employees/contractors or targeted employee groups
  • ongoing training and awareness for all employees/contractors or targeted employee groups
  • security briefings for guests

These descriptions should include, at a minimum, any security training and site orientation programs, security incident reporting and investigation management.

7) SOPs: A list of SOPs and a short description of each demonstrating the procedures in place to prevent, detect and respond to potential security incidents as outlined in Appendix D: Organizational Security Plan SOP Priority Areas must be provided.

8) Other security elements: A description of other security elements or features of the facility that would be helpful in evaluating the application (e.g., if the applicant will have measures in place to protect information technology infrastructure from a cyber-attack, business continuity plans, etc.)

9)Attestations: Provide the following signed attestations:

Physical Security: Attestation signed and dated by the head of security stating that they have reviewed the physical security of the site including the site plan and how the physical security requirements are met.

Organizational Security Plan: Attestation signed and dated by the head of security and responsible person that the organizational security plan has been approved.

Important: For Sale for Medical Purposes without possession, there is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Record Keeping Description" section.

Table 13: Physical Security Requirements for Standard Processing, Standard Cultivation and Sale for Medical Purposes with Possession Licences
Requirement Required details to include

Site plan (including floor plans)

The overall site plan must include the following details.

  • The perimeter of the site must be clearly identified. Indicate whether the site perimeter is defined by a fence or the building envelope.
  • The footprint of any building(s) must be clearly identified.
  • Indicate if the building is a multi-unit building or a stand-alone site (i.e., single unit). If it is a multi-unit building, the site perimeter should be placed accordingly and all units must be labelled with information on their current use (i.e., company name).
  • The location of any outdoor cultivation area must be clearly identified. For any outdoor area, the latitude and longitude coordinates for all four corners must be indicated.
  • The locations of, and area covered by the security devices and visual monitory devices for the site perimeter and any outdoor cultivation area.
  • All security devices must be clearly identifiable and uniquely labeled.

If there are areas, including buildings, that will not be used exclusively by the applicant, or areas that will be used by the applicant to conduct activities other than activities with cannabis, these areas must be outside of the proposed site perimeter.

Additionally, the application must also include a floor plan for each building with the following details.

  • Clear delineation of rooms where operations, grow and storage activities, as applicable, take place.
  • Clear identification of storage area(s) and the areas it is located within that meet the requirements of section 67 of the regulations, as applicable.
  • The locations of and area covered by the security devices and visual monitoring devices as they relate to any operations area (including grow areas) and storage areas, as applicable.
  • All security devices must be clearly identifiable and uniquely labeled.
  • Product flow between the rooms must be identified.

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Aerial View" section.

Security reports

Provide the following information to demonstrate how the intrusion detection system requirements will be met.

  • Alarm test reports for all intrusion detection devices for the site perimeter, all operations areas (including indoor and outdoor grow areas), and storage areas. These reports must contain the date and time of the test, the name of the device and location of the device.
  • A list of which alarm partition each intrusion detection device is assigned to.
  • Access (entry and exit) log reports for all doors leading to and from storage areas. These reports must contain the date and time of each access, the name of the device, location of the device and the identity of the individual entering and exiting from each storage area.

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Organizational Security Plan" section.

Visual evidence

Provide the following information in the site evidence package.

  • Guided video tour of entire site (including both indoor and outdoor areas), highlighting all security features of the site perimeter, operations areas (including all grow areas) and storage areas. All devices must correspond to their location as indicated on the site plan (including all floor plans).
  • Photographic overview of each side of the defined site perimeter.
  • Visual recording device footage that includes the front, back and sides of the defined site perimeter (e.g., east, west, south and north walls). Complete coverage may be best demonstrated by displaying multiple visual recording device feeds that capture an individual walking around the perimeter.
  • Footage from all visual recording devices in each operations areas (including the entry and exit points of the grow areas) and all storage areas.

All video and images must meet the following criteria:

  • Have sufficient resolution to clearly visualize the area (not a pixelated image);
  • Capture the entirety of the areas identified (i.e. no blind spots and/or obstructed views); and
  • Demonstrate the visual recording devices ability to capture the required information in both low light and night time conditions.

Important: Due to limitations on file size within the CTLS, site evidence packages are not able to be submitted as a part of the CTLS application. The site evidence package must be submitted to Health Canada outside of the CTLS. Refer to 7.1.1 Submission of Site Evidence for more information on how to submit site evidence.

Additional Information

Provide the following information to demonstrate how physical security requirements will be met.

  • Physical Barrier and Site Design
    • Description of the site and how it will prevent unauthorized access. Include any access controls at entry or exit points of the site such as windows, doors and vents.
    • Description of materials used in the construction of the physical barriers, as applicable, for the site perimeter and for all of the operations areas (including all grow areas) and storage areas, this may include fences, walls, floors, ceilings, and doors to ensure prevention of intrusion.
  • Visual Monitoring Devices
    • The type and specifications of the visual monitoring devices and how the devices meet the requirements (including operating temperature range, and any special features such as infrared or night vision and weatherproofing).
    • Description of how monitoring will be maintained at all times (e.g., during a power outage).
  • Intrusion Detection Devices
    • The type and specifications of the system installed for intrusion detection (including operating temperature range, motion detection range if applicable, intended use, and any special features such as weatherproofing, tamper-resistance).
    • Description of how intrusion detection system will be maintained at all times (e.g., during operating hours and a power outage).
    • Description of how any attempted or actual tampering with the system will be detected.
  • Restricted Access
    • Description of how the access to operations areas (including grow areas), and storage areas will be restricted to individuals whose presence is required by their duties.
    • Details on the types, specifications, and locations of access control or restriction devices installed and operating (e.g., Proximity card readers or keypads with electric door strikes or electromagnetic locks, door lock and key, combination lock, padlock).
    • Information on how and which personnel will be given access (e.g., issued cards, fobs, PINs, keys).
  • Access Log
    • Description of how access to storage area will be logged.
    • Method used to record the identity of every individual entering or exiting a storage area and the information that will be recorded.
  • Monitoring and Response
    • Information on how the intrusion detection devices will be monitored continuously (i.e. 365 days a year, 7 days a week and 24 hours a day), either on-site or off-site (e.g., use of a ULC-certified monitoring company).
    • Information on the procedure in place for when the intrusion detection system's alarm is triggered, and the procedure for creating and retaining records of detected occurrences.

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Organizational Security Plan" section.

Table 14: Physical Security Requirements for Micro-Cultivation, Micro-Processing, and Nursery Licences
Requirement Required details to include

Site plan (including floor plans)

The overall site plan must include the following details.

  • The perimeter of the site must be clearly identified. Indicate whether the site perimeter is defined by a fence or the building envelope.
  • The footprint of any building(s) must be clearly identified.
  • Indicate if the building is a multi-unit building or a stand-alone site (i.e., single unit). If it is a multi-unit building, the site perimeter should be identified accordingly and all units must be labelled with information on their current use (i.e., company name).
  • The location of any outdoor cultivation area must be clearly identified. For any outdoor area, the latitude and longitude coordinates for all four corners must be indicated.

If there are areas, including buildings, that will not be used exclusively by the applicant, or areas that will be used by the applicant to conduct activities other than activities with cannabis, these areas must be outside of the proposed site perimeter.

Additionally, the applicant must also include a floor plan for each building with the following details.

  • Clear delineation of rooms where operations, grow and storage activities, as applicable, take place.
  • Product flow between the rooms must be identified.

Delineate the respective surface areas to demonstrate how the site meets the surface area threshold (including both indoor and outdoor grow areas). As well, it should indicate whether the surface area comprises of multiple surfaces (e.g., is vertically arranged).

  • The delineated area shown on the site plan and/or floor plan should include dimensions which demonstrate how the total surface area of the cannabis plants do not exceed the applicable threshold.
  • A sample calculation should be included to demonstrate how the total surface area does not exceed the applicable threshold.

Information: For micro-cultivation, plant surface area cannot exceed 200 m2 (includes multiple surfaces such as surfaces vertically arranged). For nursery seed production the total surface area cannot exceed 50 m2 (for all the parts of budding or flowering plants).

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Aerial View" section. Key or cautionary information, in particular, around data into the CTLS.

Visual Evidence

Provide the following information in the site evidence package.

  • Guided video tour of entire site (including both indoor and outdoor areas), highlighting the entire site perimeter and all storage areas.
  • Visual footage showing entire physical barrier for the site and all storage areas.
  • Photographic overview of each side of the defined site perimeter.

Important: Due to limitations on file size with the CTLS, site evidence packages are not able to be submitted as a part of the CTLS application. The site evidence package must be submitted to Health Canada outside of the CTLS. Refer to 7.1.1 Submission of Site Evidence for more information on how to submit site evidence.

Additional Information

Provide the following information to demonstrate how physical security requirements will be met.

  • Physical Barrier and Site Design
    • Description of the site and how it will prevent unauthorized access. Including any access controls at entry or exit points of site such as windows, doors and vents.
    • Description of materials used in the construction of the physical barriers, as applicable, this may include fences, walls, floor/ceiling and doors to ensure prevention of intrusion (include this for both site perimeter and for all of the storage areas).
  • Restricted Access
    • Description of how the access to storage areas will be restricted to individuals whose presence is required by their duties.
    • Details on the types, specifications, and locations of access control or restriction devices installed and operating (e.g., Proximity card readers or keypads with electric door strikes or electromagnetic locks, door lock and key, combination lock, padlock).
    • Information on how and which personnel will be given access (e.g., issued cards, fobs, PINs, keys).

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Organizational Security Plan" section.

Table 15: Physical Security Requirements for Analytical Testing and Research Licences
Requirement Required details to include

Site plan (including floor plans)

The site plan must include the following details.

  • The perimeter of the site must be clearly identified. Indicate whether the site perimeter is defined by a fence or the building envelope.
  • The footprint of any building(s) must be clearly identified.
  • Indicate if the building is a multi-unit building or a stand-alone site (i.e., single unit). If it is a multi-unit building, the site perimeter should be identified accordingly and all units must be labelled with information on their current use (i.e., company name).

If there are areas, including buildings, that will not be used exclusively by the applicant, or areas that will be used by the applicant to conduct activities other than activities with cannabis, these areas must be outside of the proposed site perimeter.

The site plan must also include floor plans with the following details.

  • Within all building(s), provide a clear delineation of rooms where storage activities take place.

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Physical Security Document" section.

Additional Information
(Analytical testing licence only)

Provide the following information to demonstrate how physical security requirements will be met.

  • Description of how the physical barrier surrounding the storage area will prevent unauthorized access.
  • Description of materials used in the construction of the storage area physical barrier and how this will prevent intrusion.
  • Description of how the access to storage areas will be restricted to individuals whose presence is required by their duties.

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Physical Security Document" section.

Additional Information
Research licence only)

Provide a description of how the operations areas are designed to prevent unauthorized access.

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Physical Security Document" section.

6.9 Good production practices

Information:

Good production practices (GPP) requirements apply to a number of activities across many licence classes.

Only some of these must be demonstrated at the time of application. However, GPP compliance may be verified at any time by Health Canada. Applicants for analytical testing, research, and sale for medical purposes without possession licences do not need to demonstrate compliance with GPP as part of the licensing application process.

As part of the licensing application process, the applicant is required to provide a Good Production Practices Report that clearly demonstrates how the GPP requirements and the Good Production Practices Guide for Cannabis provide more information on what is required.

Table 16: GPP requirements for Cultivation, Processing, Sale for Medical Purposes with Possession Licences
Requirement Elements to demonstrate that GPP requirements will be met:

Good Production Practices Report

Provide the following information as a part of the Good Production Practices Report.

  • Description of how and where cannabis will be stored, including conditions of any storage area(s) (e.g., presence of temperature and/or humidity control) and how the requirements of section 82 of the Cannabis Regulations are met.
  • Include a description of the storage procedure for the various categories of cannabis (e.g., in-process, bulk, immediate containers, samples, quarantined, product approved for sale, rejected, returned or recalled product, and material awaiting destruction) and how these procedures will ensure that the requirements of section 82 of the Cannabis Regulations are met.
  • Process flow diagram and/or a "step-by-step" description showing the movement of cannabis and/or cannabis products through the building and the separation of operations areas (including grow areas), storage areas and non-cannabis areas.
  • Description and/or depiction of the building detailing the construction of the surfaces such as walls, ceilings, (e.g., non-porous panels, sealant), floors (e.g., polished concrete, epoxy sealant), and seams (e.g., caulking, joints between floor, walls, and ceiling) demonstrating how the requirements of section 84 of the Cannabis Regulations are met.
  • Description of water supply source; if the source is not municipal water, provide evidence that the water meets potable water standards (e.g., analytical test results of the water source). Potable water should meet the Guidelines for Canadian Drinking Water Quality see http://www.hc-sc.gc.ca/ewh-semt/water-eau/drink-potab/guide/index_e.html for more information.
  • Description of any non-potable water sources and how cross connection with potable water sources will be prevented.
  • When the water source is not municipal water, provide a description of the water quality testing procedure used, including the frequency of testing.
  • Description of air filtration system, including type, specifications, number and location of air filters installed (e.g., HEPA, carbon, charcoal, combination, portable filters) and a diagram and/or floor plan detailing the air filtration and ventilation system (e.g., air intake and air exhaust locations and direction of air flow within the building(s)).
  • Description of the sanitation program demonstrating how the requirements of section 87 of the Cannabis Regulations are met for all operations areas (including grow areas), storage areas, transitory areas and non-cannabis areas. This should include the frequency or schedule.

Visual Evidence

Video and photographic evidence must include the following details.

  • Guided video tour of entire site (including both indoor and outdoor areas), highlighting all GPP features of the building, including all operations areas (including grow areas) and storage areas.
  • Close-up images of the surfaces (including walls, floors, ceilings and joints) of all operations areas (including grow areas) and storage areas demonstrating that they meet the requirements of section 84 of the Cannabis Regulations.
  • A video of an individual entering and moving through different areas of the facility demonstrating the intended production process flow through the facility.

Important: Due to limitations on file size within CTLS, site evidence packages are not able to be submitted as a part of the CTLS application. The site evidence package must be submitted to Health Canada outside of CTLS. Refer to 7.1.1 Submission of Site Evidence for more information on how to submit site evidence.

Starting material authorized quantities
(Cultivation licence only)

Provide the types of starting material (e.g., plants or seeds) and authorized source of this material (e.g. federally authorized licence holder or authorized foreign source). In the case where the applicant intends to use cannabis plants or cannabis plant seeds that were not obtained in accordance with the former Access to Cannabis for Medical Purposes Regulations or with the Cannabis Regulations or from a person authorized to sell cannabis under a provincial Act, they must provide a declaration, signed and dated by the applicant, indicating the quantity of cannabis plants and cannabis plant seeds that they will have in their possession on the effective date of the licence. This declaration can be provided to Health Canada at any time prior to licensing, including when the applicant is contacted by an officer as part of the review process.

Important: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Good Production Practices" section.

6.10 Record keeping (and reporting)

Information: Required for all licence types, based on the regulatory requirements.

There are a number of regulatory requirements for record keeping and reporting that must be met by a licence holder. The applicant is encouraged to refer to the Cannabis Regulations and Appendix E: Record Keeping Attestation for details about record keeping required for the licensing process, and to consult the Cannabis Regulations to obtain an understanding of the post-licensing regulatory record keeping and reporting requirements.

Table 17: Record keeping (and reporting) requirements
Requirement Required details to include

Record keeping attestation

Include a signed and completed attestation form found in Appendix E: Record Keeping Attestation.

Copy of government issued identification (Analytical testing and research licences only

In order to verify the identity of the applicant and/or responsible person, a copy of government-issued identification must be provided.

Important: NOTE: There is no specific section in the current version of the CTLS to upload this information. This information should be uploaded as an attachment under the "Record Keeping Description" section.

Key investor reports (Cultivation, processing or sale for medical purposes licences only)

An applicant seeking a licence for cultivation, processing or sale for medical purposes, who does not trade its shares on the public market, must provide information on their key investors as part of an application. Please refer to Appendix G: Key investors for more information. The information includes the key investor's name and address; a description of the means by which the key investor exercises, or is in a position to exercise, control over the licence holder; details regarding any benefit received as a result of being an investor; and whether the controlling interest has been, will be, or could be assigned, pledged, mortgaged, hypothecated or sold, in whole or in part, to any person.

If there are no investors, an attestation must be provided in this regard.

Refer to section 241 of the Cannabis Regulations for the additional record keeping and reporting requirements relating to investors once licensed.

Important: Note: There is no specific section in the CTLS to upload this information. This information should be uploaded as an attachment under the Record Keeping Description section.

Detailed description of the record keeping methods proposed for additional requirements for sale for medical purposes
(Sale for medical purposes licence only)

Include a description of the record keeping methods that will capture the following information:

  • medical client registration information
  • filling of orders and refusal to fill orders
  • medical documents provided by clients
  • communication with provincial or territorial professional licensing authorities

Examples of the following should also be provided

  • The medical practitioner verification process;
  • An example of the registration document that will be provided to clients upon registration;
  • A description of how the system will ensure that the quantity of cannabis distributed or sold will not exceed the equivalent of 150g of dried cannabis (calculated in accordance with Schedule 3 of the Cannabis Act).

Important: There is no specific section in the CTLS to upload this information. This information should be uploaded as an attachment under the Record Keeping Description section.

7.0 Submitting an application and administrative procedures

Once the applicant has included all of the requirements in the application within the CTLS and is ready to submit the application, the additional steps in the licensing process will begin as outlined in Figure 3: Steps following submission of an application.

Figure 3: Steps following submission of an application
Figure 3
Figure 3 - Text Description

Section 7.1 of this guide outlines the steps for submitting the application.

After this, section 7.2 outlines the next steps, which includes application screening, review and security clearance, pre-licensing and approval process, and then issuance of licence. Requests for more information can occur at any point in time through this process and are found in section 7.3 of this guide.

7.1 Submitting the application

Once the applicant has input all required information, they can submit their application. This involves the following steps:

  • Self-Identification: The CTLS includes an opportunity to self-identify as Indigenous affiliatedFootnote 4. A no response includes not wanting to self-identify.
  • Submission (declarations and attestations): Prior to submitting the application, the applicant, through their responsible person, must electronically attest to the following:
    • that the proposed personnel submitted as part of the application are familiar with the provisions of the Cannabis Act and its Regulations that will apply to the licence
    • that none of the activities that the applicant is proposing to conduct in the application will be conducted, or records of these activities maintained, at a dwelling-house
    • that all information and documents submitted in support of the application, are, to the best of the applicant's knowledge, correct and complete
    • that the person submitting the application has the authority to bind the application/applicant and to have overall responsibility for the management of the activities to be conducted under the licence

Once the application is submitted, it appears in the "Submitted Licence Applications" section of the CTLS. Each application will have a unique Licence Application ID. All correspondence with Health Canada in relation to the application should include this identifier in the subject title. It is important to note that once an application is submitted, no further changes can be made by the applicant. Refer to section 7.3.3 Changes to an application/unsolicited information for more information.

Tip: An applicant may check the status of their application in the CTLS at any time during the application process. For more information, refer to Appendix F: Application Status Meanings in CTLS.

Important for Processing, Cultivation, and Sale for Medical Purposes with Possession Licences: A site evidence submission must be received by Health Canada before an application can be considered. Site evidence package submissions must be received by Health Canada within 10 business days following the submission of their CTLS application. Applicants who do not submit their site evidence package within the timeframe may have their application refused as incomplete. or cautionary information, in particular, around data into the CTLS.

7.1.1 Submission of Site Evidence

If you are applying for a Processing, Cultivation, and Sale for Medical Purposes with Possession Licence, please submit visual evidence in accordance with the following:

  • All submitted packages must be clearly identified with the APP number (APP-XXXXXXXXXX-20XX) associated with the CTLS portion of the licence application. Any packages which are inappropriately identified may result in a delay to the review process or refusal of the application.
  • Photographic evidence must be provided in PDF-formatted files.
    • Visual evidence for each operations area (including grow areas) and storage areas identified must be submitted in separate files (e.g. Grow-Room.pdf, Facility-Perimeter.pdf)
  • Visual evidence must show the area in question followed by images derived from the visual monitoring devices located in those cannabis-present areas.
  • Video evidence must be submitted in any of the following supported formats:
    • MP4 Video file (.mp4, .m4v, .mp4v, .3g2, .3gp2, .3gp, .3gpp)
    • QuickTime Movie file (.mov)
    • Audio Visual Interleave (.avi)
    • Microsoft Digital Video Recording (.dvr-ms)
    • Moving Pictures Experts Group (.mpg, .mpeg, .m1v, .mp2, .mp3, .mpa, .mpe, .m3u)

Please note that site evidence packages must be submitted to Health Canada electronically using USB storage devices. If submitting site evidence packages using a courier service, please provide the Licensing and Medical Access Directorate with the tracking number for the package. The tracking number should be sent in an email to HC.licensing-cannabis-licences.SC@canada.ca with the APP number (APP-XXXXXXXXXX-20XX) provided by the CTLS listed in the subject line of the email.

The submission package can be sent to the following address:
Licensing and Medical Access Directorate
Health Canada
Address Locator: 0300A
Ottawa ON K1A 0K9

Due to Health Canada's internal IT security policy, any information submitted by CD ROM storage will be returned to the applicant. Cloud storage hosting services are also not permitted.

7.2 After submission

Once an application is submitted in the CTLS, there are a series of steps Health Canada undertakes to review and issue the licence as outlined below. It is important to note that in accordance with subsection 62(5) of the Cannabis Act, the Minister may request the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to consider the application. This would be in the form of a request for more information as outlined in section 7.3.1 of this guide.

7.2.1 Application screening

  • During screening, the application, attached documents and, if required, the submitted site evidence package are assessed for completeness, legibility and ability to be further assessed. For Processing, Cultivation, and Sale for Medical Purposes Licence applications there is a 30 day service standard for completion of screening of the application by Health Canada. Please note that application screening cannot take place until Health Canada receives the site evidence package. The 30 day service standard will commence upon receipt of the complete application submission.

7.2.2 Review and security clearance

  • Once an application has passed the screening stage, and security clearance applications are being processed, the application will undergo a detailed review of both documents submitted through the CTLS and, if required, visual evidence submitted as a part of the site evidence package to verify that the requirements are met. Health Canada will work with the RCMP on security clearance applications. Refer to Security Clearances under the Cannabis Act and Regulations for more information on the security clearance process.

7.2.3 Pre-licensing and approval process

Following the review of this information, an on-site pre-licence inspection by Health Canada inspectors may be deemed necessary prior to further licensing decisions. If an inspection is required, the inspection team will contact the applicant to schedule the pre-licence inspection. In the case where an on-site pre-licence inspection is not required, the licence issuance will be based on the thoroughness of information submitted to Health Canada.

7.2.4 Issuance of licence:

Once all information has been reviewed, including the results and observations from a pre-licence inspection, if necessary, and all security clearances have been granted, an initial licence for authorized activities is issued. A hard copy of the licence as well as an accompanying issuance letter detailing any conditions around the issued licence is mailed to the identified mailing address. In addition, all security-cleared key personnel are sent letters regarding the status of their security clearances for that site, under that application. Following issuance of the licence, Health Canada holds a teleconference with the new licence holder to discuss the licence, including any conditions.

Immediately after issuance of their licence, licence holders will generally be permitted to sell cannabis, as authorized by their licence as set out in the Cannabis Regulations and in accordance with any licence conditions. Cultivation and processing licence holders will generally be restricted to the sale of cannabis products that are cannabis plants and seeds to a holder of a licence for sale, and a person authorized to sell cannabis under a provincial Act by reason of subsection 69(1) of the Cannabis Act. The sale of cannabis products of all other cannabis classes will usually be restricted by a condition placed on the licence. For processing licence holders, to gain authorization for the sale of cannabis products of all other cannabis classes, an amendment request must be submitted to the change this condition on a licence. Refer to the Cannabis Licensing Management Guide for more information on how to complete an amendment submission.

Tip: Licence holders must ensure that the quality of cannabis products they produce meet all applicable requirements. When a licence holder is first licensed, activities may be limited, particularly prior to being authorized to conduct the activity of sale for medical purposes. This graduated licensing is for the purpose of verifying that cannabis products intended for sale meet all of the quality standards set out under the Cannabis Regulations.

7.3 Administrative procedures

7.3.1 Receiving and responding to a request for more information

It is the applicant's responsibility to meet all of the licensing requirements. If information submitted as part of the application is unclear or requires further detail to show how it meets the requirements, Health Canada asks the applicant to clarify this information through a request for more information.

In these cases, Health Canada strives to be clear about what information is needed from the applicant. If the applicant is unclear about what is required to respond to the request for more information, they may contact Health Canada by email or phone for further guidance (refer to section 8.0 of this guide). Note that it is not a requirement to retain the services of a third party (e.g., consultant) to prepare responses to Health Canada.

A request for more information will be emailed to the responsible person. The applicant must respond by email, generally within 5 business days of the request. Some requirements for responding to requests for more information include:

  • Responses should be comprehensive and comment on each of the elements noted in the request for additional information.
  • The applicant should not resubmit a revised version of the original documents unless requested to do so, but should provide a clear and detailed response specific to each point requested. This can be submitted in tabular format or in a report format with subheadings associated with each item noted in the request.
  • It is important to be as specific and as detailed as possible when addressing each section. Incomplete responses may delay processing or lead to a refusal to consider an application.

Tip: If the applicant wishes another representative to be the primary recipient of communications or receive a copy of all communications, the applicant must provide a written and signed consent to Health Canada that permits Health Canada to communicate details about the application to the third-party individual. The consent must indicate the name(s) of the individuals, the application number and be sent to HC.licensing-cannabis-licences.SC@canada.ca from the email address captured within the CTLS for the responsible person with the subject line "Consent to Communicate". Note that as an applicant proceeds through review process, the application status and contact information of the applicant may be shared with persons authorized under subsection 69(1) of the Cannabis Act.

7.3.2 Refusals and withdrawals

Health Canada may refuse to consider an application if any of the required information is not provided.

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

  • Issuing a licence 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 the Cannabis Act, the Controlled Drugs and Substances Act, the FDA or any associated regulations, including an order or a condition of another licence, in the past 10 years
  • 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
  • The combination of classes or subclasses of licences proposed at the same site.  For further details refer to Table 2: General Guide for Combinations of Licence Classes and Subclasses at a Single Site and section 29 of the Cannabis Regulations.
  • The Minister is of the opinion that refusal is in the public interest

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 licence. This intent to refuse notice will generally provide the applicant with 30 days to respond, after which a notice of refusal will be issued.

The notice of refusal officially 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 licence. All decisions to refuse an application are without prejudice to filing a new application for a licence. If an applicant wishes to submit a new application at a future time, it will be processed as such. Information and data submitted to support an application will not be returned to the applicant.

At any time during the review of their application, the applicant may withdraw the application through the CTLS. Withdrawal of an application is without prejudice to re-filing. If an applicant wishes to resubmit an application at a future time, the application will be processed as a new application. Information and data submitted to support the original application will not be returned to the applicant.

For personnel security clearances, if the intent is to refuse to grant a security clearance, the individual applicant will be notified in writing of the basis for the intent to refuse and will be provided with a minimum of 20 days to make written representations. The individual applicant as well as the associated licensing applicant will be notified in writing if the Minister refuses to grant the clearance.

If an individual's security clearance is refused or cancelled, the individual who has been refused a security clearance cannot submit a new application for a security clearance until the circumstances that resulted in the refusal or cancellation have changed or until five years have elapsed after the refusal or the cancellation.

7.3.3 Changes to an application/unsolicited information

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

Any unsolicited information or submissions not clearly labelled with the above information may not be assessed by Health Canada.

8.0 Contact us

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

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

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

9.0 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 require in order to be compliant with the Cannabis Act and its Regulations.

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

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

Appendix A: Key individuals

Note that for the purposes of an application, other individuals may require accounts and/or security clearances in addition to the key individuals identified in this table. Refer to the Cannabis Regulations and Section 5 of this guide for more information.

Appendix A table 1: Key individuals
Individuals Responsibilities and qualifications (as defined in the Regulations) Cultivation Processing Sale for Medical Purposes Analytical Testing Research
Standard Micro Nursery Standard Micro
Licence Holder (as an Individual)
  • Overall responsibility for the licence

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Required to be identified

Responsible Person
  • A holder of a licence must retain the services of one individual as the responsible person who has the authority to bind the licence holder
  • Has overall responsibility for the activities conducted by the licence holder
  • Must have sufficient knowledge of the provisions of the Act and Regulations that apply to the holder of the licence

May designate one qualified alternate
Will be the official point of contact with Health Canada and through the CTLS

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Required to be identified

Head of Security
  • Responsible for ensuring that the physical security measures comply with Part 4 of the Cannabis Regulations
  • Responsible for the OSP

May designate one qualified alternate

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

N/A N/A
Master Grower
  • Responsible for the cultivation, propagation and harvesting of cannabis
  • Must be familiar with the provisions of the Act and Regulations that relate to his or her activities.

May designate one qualified alternate

Required to be identified

Security clearance required

Required to be identified

Security clearance required

Required to be identified

Security clearance required

N/A N/A N/A N/A N/A
QAP

Responsible for assuring the quality of the cannabis before it is made available for sale

Required to have the training, experience and technical knowledge related to the GPP requirements of the Regulations

Responsible for investigating every complaint received in respect of the quality of the cannabis and, if necessary, taking corrective and preventative measures

Responsible for approval of methods and procedures related to GPP

May designate up to two alternate QAPs who can replace the QAP, if and when required. These alternates must be identified in advanceand requires approval from Health Canada, because there are specified qualifications for this position

N/A N/A N/A

Required to be identified

Security clearance required

Required to be identified

Security clearance required

N/A N/A N/A
Head of Laboratory
  • Work at the licensed site and be responsible for the testing activities under section 91 of the Cannabis Regulations (testing of each lot/batch for composition)
  • Required to be familiar with the applicable provisions of the Act and associated regulations
  • Have knowledge and experience related to the duties of the position
  • Possess a degree in a science that is related to the work to be carried out awarded by either a Canadian university or, if awarded by a foreign university, one that is recognized by a Canadian university or Canadian professional association

An applicant may designate one or more alternates who can replace the Head of Laboratory, if and when required. These alternates must be identified in advance and requires approval from Health Canada, because there are specified qualifications for this position

N/A N/A N/A N/A N/A N/A

Required to be identified

N/A

Appendix B: Cannabis licence classes and subclasses

This table provides a summary of the cannabis licence classes and subclasses, and activities that can be authorized under the Cannabis Regulations. The Cannabis Regulations should be referred to for additional detail. In order to conduct any of the activities, they must be authorized by the licence.

Appendix B Table 1: Cultivation Licences
Subclass Restrictions Authorized Activities (if authorized by licence) Notes
Standard Cultivation no data
  • Possess cannabis
  • Obtain dried or fresh cannabis, cannabis plants or cannabis seeds by propagating, cultivating, harvesting
  • For the purpose of testing, alter the chemical or physical properties of the cannabis
  • Sell and distribute dried cannabis, fresh cannabis, cannabis plants or seeds to other licence holders (cultivators, processors, analytical testers, researchers, cannabis drug licence holders), with the exception that dried cannabis or fresh cannabis cannot be sold to the holder of a nursery licence
  • Sell and distribute cannabis plants or seeds to a licensed nursery
  • Sell and distribute cannabis products that are plants or seeds to a licence holder that is authorized to sell cannabis for medical purposes or to a person authorized to sell cannabis under a provincial or territorial Act
  • Send and deliver cannabis products that are plants or seeds to the purchaser at the request of a licence holder that is authorized to sell cannabis for medical purposes or to a person authorized to sell cannabis under a provincial or territorial Act
  • Conduct ancillary activities (e.g., drying, trimming, milling, etc.)
  • An applicant may apply for a standard cultivation licence, even with a proposed plant surface area of less than 200 square metres but standard cultivation requirements will apply in this case
  • Cultivation may be conducted indoors or outdoors
Micro-Cultivation
  • Plant surface area cannot exceed 200m2 (includes multiple surfaces such as surfaces vertically arranged)
  • Cultivation may be conducted indoors or outdoors but the cannabis plant surface area includes any indoor/outdoor areas at any single time)
Nursery
  • For seed production, total surface area of no more than 50m2 must contain all the parts of budding or flowering plants
  • Maximum of 5kg of flowering heads harvested from plants with the exception of seeds
  • Must destroy the flowering heads (with the exception of the cannabis plant seeds), leaves and branches of the plants within 30 days of harvesting them
  • Possess cannabis
  • Obtain cannabis plants or plant seeds by propagating, cultivating, harvesting
  • For the purpose of testing, alter the chemical or physical properties of the cannabis
  • Sell and distribute cannabis plants or seeds to other licence holders (cultivators, processors, analytical testers, researchers, cannabis drug licence holders)
  • Sell and distribute cannabis products that are plants or seeds to a licence holder that is authorized to sell cannabis for medical purposes or to a person authorized to sell cannabis under a provincial or territorial Act
  • Send and deliver cannabis products that are plants or seeds to the purchaser at the request of a licence holder that is authorized to sell cannabis for medical purposes or to a person authorized to sell cannabis under a provincial or territorial Act
  • Conduct ancillary activities (e.g., drying )
  • Cultivation may be conducted indoors or outdoors
Appendix B Table 2: Processing Licences
Subclass Restrictions Authorized Activities (if authorized by licence) Notes
Standard Processing no data
  • Possess cannabis
  • Produce cannabis, other than obtaining it by propagating, cultivating, or harvesting
  • For micro-processing, the cannabis cannot be obtained by synthesis.
  • Sell and distribute cannabis to other licence holders (processors, analytical testers, researchers, cannabis drug licence holders)
  • Sell and distribute to licensed micro-cultivators or standard cultivators:
    • dried cannabis, fresh cannabis, cannabis plants, or cannabis seeds
    • cannabis produced for the purposes of testing that is necessary to determine the chemical characterization of cannabis, such as a reference standard
  • Sell and distribute to licensed nursery:
    • cannabis plants or seeds
    • cannabis produced for the purposes of testing that is necessary to determine the chemical characterization of cannabis, such as a reference standard
  • Send and deliver cannabis products to a licence holder that is authorized to sell cannabis for medical purposes or to a person authorized to sell cannabis under a provincial or territorial Act
  • Send and deliver cannabis products that are plants or seeds to the purchaser at the request of a licence holder that is authorized to sell cannabis for medical purposes or to a person authorized to sell cannabis under a provincial or territorial Act
  • All activities must be conducted indoors
Micro-processing
  • Maximum of 600kg of dried cannabis (or equivalent) in 1 calendar year as per section 21 of the Cannabis Regulations.

Note: If licence holder also holds a micro-cultivation licence for the same site and the cannabis comes exclusively from that site, this maximum quantity does not apply.

Appendix B Table 3: Sale for Medical Purposes Licences
Subclass Restrictions Authorized Activities (if authorized by licence) Notes
N/A
  • Must sell cannabis products in the packaging in which they were sold or distributed to them
  • Possess cannabis products
  • Sell or distribute cannabis products to a client
  • Sell or distribute cannabis products to a licence holder (with the exception of a cultivator)
  • Sell or distribute cannabis products that are dried, fresh, plants or cannabis seeds to micro-cultivator or standard cultivator
  • Sell or distribute cannabis products that are plants or plant seeds to a licensed nursery
  • Sell or distribute cannabis products other than plants or seeds to a hospital employee
  • Requirements for the application for a sale for medical purposes licence with possession of cannabis differ from those that do not have possession. Refer to Section 6 of this guide for more information
  • Sale is to registered clients authorized to use cannabis for medical purposes
Appendix B Table 4: Analytical Testing Licences
Subclass Restrictions Authorized Activities (if authorized by licence) Notes
N/A
  • All samples of a lot or batch of cannabis must be destroyed within 90 days of the completion of the testing
  • If testing is not started within 120 days of sample receipt, samples must be destroyed
  • Possess cannabis
  • Alter the chemical or physical properties of the cannabis for the purposes of testing
no data
Appendix B Table 5: Research Licences
Subclass Restrictions Authorized Activities (if authorized by licence) Notes
N/A no data
  • For the purpose of research, possess, produce, and transport, send, or deliver cannabis between sites that are authorized by the licence
  • Sell cannabis plants or seeds to a cultivator, another researcher, cannabis drug licence holders, the Minister, exemption holder
  • In general, research licence holders will be required to destroy all cannabis in their possession upon the completion of their research project as part of the terms and conditions of their licence. They may be authorized to conducted limited sale and distribution activities such as the sale of cannabis plants and seeds to another researcher or a cultivation licence holder.

Appendix C: Personnel security clearance application requirements

Each individual requiring a security clearance must submit a Security Clearance Application in the CTLS with the following information:

  • Biographical information: Including name, date of birth, preferred official language, location of birth, birth certificate number and issuing province or territory, and descriptors such as eye and hair colour, weight and height. A valid piece of photo identification issued by the government (Canada or province or territory) or a copy of the passport with the passport number, country, expiry date and photograph must also be provided.
  • Criminal charges and convictions: The applicant must obtain a criminal record check and include information about past criminal charges and convictions in the application.

Tip: As part of the criminal record check process, the applicant must provide a "Security Clearance Fingerprint Third Party Consent to Release Personal Information Form." This must be provided to the local police force, the RCMP, or a private fingerprinting agency accredited by the RCMP. The form authorizes the RCMP to release the criminal record check and fingerprint verification results to Health Canada. Following fingerprinting, a document control number (DCN) is provided on the form, which is used as the identifier for the record check. Refer to the Health Canada website for this form.

  • Residential addresses: Must be included for the past five years, prior to the time of application.
  • Employment, education and unemployment history: Must be included for the past five years, prior to the time of application.
  • Marital status: Must include details of current and any previous spouses or common-law partners over the last five years.
  • Time spent outside of country of residence: The applicant must provide the dates, destination and purpose of travel for any travel exceeding 90 days in the past five years.
  • Signed consent: As part of this application, a consent and certification form must be uploaded with a signature by the individual. Refer to Appendix K: Security Clearance Consent and Certification Form.
  • Submission: The applicant must attest that the information, including supporting documents, in the application is true prior to submission.

Appendix D: Organizational security plan SOP priority areas

Health Canada has identified four priority security areas that all applicants and licence holders will be expected to address through SOPs. The number of SOPs required is at the discretion of the applicant, but all four priority areas below must be addressed. As part of its OSP the applicant is required to submit a list and short description of its SOPs, not the SOPs themselves.

Priority area 1: Security clearances and adverse information about employees

Risk areas and potential mitigation measures to consider:

  • Detecting and responding to new adverse information received that could compromise an employee's security clearance
  • Detecting and responding to adverse information received regarding a non-security-cleared employee that could compromise the organization's security

Priority area 2: Physical security

Risk areas and potential mitigation measures to consider:

  • Staff arrival and entry to the facility (procedure for gate/door to open, etc.)
  • Guest, vendor and contractor arrival and entry to the facility (including deliveries/pick-up)
  • Response procedures for any arrival and entry breaches
  • Staff access to areas where cannabis is present, including vault/storage areas (procedure for passing access controls/intrusion detection)
  • Guest, vendor and contractor access to areas where cannabis is present, including vault/storage areas (including deliveries/pick-up)
  • Response procedures for any access control or intrusion detection breaches to areas where cannabis is present, including vault/storage areas
  • Storage and retrieval of video monitoring footage
  • Testing of all physical security features and response procedures (frequency, method, etc.)
  • Steps and other security measures that will be taken to ensure the safekeeping of cannabis when being shipped, delivered and or transported
  • Destruction method and handling of cannabis waste

Priority area 3: Security awareness and training

Risk areas and potential mitigation measures to consider:

  • Internal security training and awareness requirements (for management and for employees)
  • How employees can report security concerns, incidents or breaches

Priority area 4: Record keeping, reporting and testing:

Risk areas and potential mitigation measures to consider:

  • Contingency plan if record keeping system fails or goes down
  • Detection of loss or theft
  • Validation that cannabis entering the facility is from a legal source
  • Protection of client information
  • Response procedure should cannabis be found to enter or leave the facility in an unauthorized manner
  • Testing of response procedures (frequency, method, etc.)

Appendix E: Licensing record keeping attestation

Download printable PDF form

PART 11 – Retention of documents and information

Applicant information

Applicant name:

Application number:

Instructions

  1. Complete the 'General Information' and 'Responsible Person Attestation Signature' fields in the attestation form provided below.
  2. Upload the completed attestation form as an attachment under the 'Record Keeping Example Section' in the Cannabis Tracking and Licensing System (CTLS).

General information

Please confirm the proposed record keeping method:

  • Electronic-based (please specify any record keeping software to be used):
  • Paper-based
  • Other:

Regulatory attestation

While applicants are expected to meet all regulatory requirements pertaining to Part 11 – Retention of Documents and Information of the Cannabis Regulations, the Licensing and Medical Access Directorate has identified requirements (see below) for which we would like to emphasize and draw your attention to as these may represent a greater risk in the event of a non-compliance.

Regulation

Inventory and distribution
224 Inventory – cannabis other than oil
225 Inventory – cannabis oil*
(*only applies to applicants applying for a processing licence)
226 Receipt of cannabis
227 Sale, distribution and export of cannabis

Destruction
229 Destruction

Security
230 Organizational security plan

Production
231 Good production practices
232 Standard operating procedures and sanitation program

Packaging and labeling
233 Packages and labels

System of control for recalls
235 System of control

Responsible person attestation signature

I, the undersigned, attest that:

  • All applicable documents and information pertaining to Part 11 – Retention of Documents and Information of the Cannabis Regulations, as required by the licence class(es) and activities being applied for at the time of licensing, will be retained accordingly for the noted retention period(s) as outlined by the respective regulation(s).
  • With respect to section 221 of the Cannabis Regulations, all applicable documents and information will be retained in a manner that will enable an audit to be made of it in a timely manner.
  • All information or documents under section 221 will be retained at the site of the licence holder, or, in the case of a person that does not hold a licence, at the person's place of business, or if they do not have one, at a place of business in Canada.

Responsible Person Name (Printed):

Responsible Person Name (Signature):

Date:

Appendix F: CTLS application status

An applicant may check the status of their application in the CTLS at any time during the application process. The table below provides an explanation of what the status means.

Draft
The application has not yet been submitted by the applicant. Health Canada does not receive, nor process, draft applications. The applicant must complete all sections of the application in order to submit an application for processing by Health Canada.
Payment (Pending)
Information on cost recovery fees will be provided by Health Canada, when applicable. The applicant has submitted the application but required payment for the processing of the application, if applicable, has not yet been processed.
Submitted
Once the payment, if applicable, is received by Health Canada, the application is considered 'submitted' and remains at this stage until the screening of the application commences.
In progress
The application has begun review by Health Canada. Refer to section 7.2 of this guide for more information.
Pending information
A request for more information has been sent and Health Canada is waiting for a response from the applicant. Refer to 7.3.1 of this guide for more information.

Appendix G: Key investors

The Regulations provide the complete definition of a key investor. In essence, a key investor is a person who exercises, or is in a position to exercise, direct or indirect control over the licence holder. When the term "in a position to exercise, direct or indirect control over the holder" is used, an individual, partnership, cooperative or corporation will be considered to be controlled by another individual or organization at any time where, at that time, the controller has any direct or indirect influence that, if exercised, would result in control in fact of the individual, partnership, cooperative or corporation.

As part of the licensing application, any person (except a corporation who trades its shares on a public market) who applies for a cultivation, processing or sale for medical purposes licence must provide certain information regarding key investors, such as the key investor's name and mailing address; a description of the means by which the key investor exercises, or is in a position to exercise, control over the holder and, if known, whether the controlling interest has been, will be, or could be assigned, pledged, mortgaged, hypothecated or sold, in whole or in part, to any person.

A person may have control in fact of an organization even though that person does not have legal control of the organization. Legal or direct control of an organization generally entails the right to elect the majority of the board of directors based on having a sufficient number of voting shares.

Control in fact includes the ability to control by any direct or indirect influence, and it may exist even without the ownership of any shares. It can take many forms such as the ability of a person to: change the board of directors or reverse its decisions; make alternative decisions concerning the actions of the organization in the short, medium or long term; directly or indirectly terminate the organization or its activities; or to appropriate its profits and property. The existence of such influence, even if it is not actually exercised, would be sufficient to result in control in fact.

In order to determine whether an investor has control in fact, and whether information about this investor needs to be reported, the following are some of the relevant general factors to consider:

  • the percentage of ownership of voting shares (when such ownership is not more than 50 per cent) in relation to the holdings of other shareholders although any ownership over 25 per cent, in combination with other factors would likely be a significant indication of control
  • ownership of a large debt of an organization which may become payable on demand
  • shareholder agreements including the holding of a casting vote
  • commercial or contractual relationships of the organization, e.g., economic dependence on a single supplier or customer.

Appendix H: Direct control

In some instances, a partnership, cooperative or corporation that holds a licence can be controlled by an individual or another partnership, cooperative or corporation. The Regulations require that individuals, or directors and officers of cooperatives or corporations, must hold a valid security clearance when they directly control any partnership, corporation or cooperative that holds a cultivator, processor or sale for medical purposes licence.

With respect to partnerships, the terms of the partnership agreement will dictate who has control. Anyone who directly controls a partnership needs to hold a valid security clearance this includes any individual, or if it is another partnership those partners, and if a corporation or a cooperative then its directors and officers.

Cooperatives and corporations can also be controlled by others individuals, partnership, cooperative or a corporation. In common language, when this kind of control is exerted by a corporation, it is often referred to as a "parent company", which is a company that is able to control another company's management and operations by influencing or electing its board of directors, among other things. The Cannabis Regulations require the directors and officers of any parent company/cooperative, which is a corporation or cooperative that has significant ownership over a subsidiary or group of subsidiaries, to hold security clearances. These partially or wholly owned companies or cooperatives are controlled by the parent, to varying degrees; however, all parent companies, for the most part, own more than 50% of a subsidiary's voting stock. This applies to any individual or partnership that owns more than 50% of a subsidiary's voting stock.

If an individual controls any of the above licence holders by holding an influential amount of voting stock or through the terms of a partnership agreement, they would require a security clearance.

Appendix I: Security clearance: Consent and certification form

PDF version (164 KB, 2 pages)

Providing misleading or false information on this application may result in a refusal or cancellation of the security clearance.

For security clearance purposes, I consent to the disclosure by the Royal Canadian Mounted Police (RCMP) to other law enforcement agencies, of any and all information provided by me in support of this application. Without limiting the generality of the foregoing, this includes information relating to my date of birth, education, residential history, employment history, and immigration and citizenship status in Canada. I also consent to the disclosure and use of my fingerprints and facial images for identification purposes.

I consent to the disclosure by law enforcement agencies to Health Canada and/or the RCMP of any and all information relevant to this security clearance application, including information in my criminal record and any other information contained in law enforcement records, including information gathered for law enforcement purposes, as well as any and all information that will facilitate the conduct of a security assessment. This includes non-conviction information, charges before the courts, findings of guilt or convictions and court orders registered in my name in the National Repository of Criminal Records and local records available to police services.

For security clearance purposes, I hereby authorize Health Canada to seek, verify, assess, collect, and retain for a period of two (2) years after the expiry date of the licence holder's licence, any and all information relevant to this application including any criminal records and any and all information contained in law enforcement files, including intelligence gathered for law enforcement purposes, and information with respect to my immigration and citizenship status, as well as any and all information that will facilitate the conduct of a security assessment. This includes non-conviction information, charges before the courts, findings of guilt or convictions and court orders registered in my name in the National Repository of Criminal Records and local records available to police services.

For security clearance purposes only, I consent to the release by other Canadian institutions or agencies to Health Canada, of information relevant to this application for a security clearance to enable Health Canada to perform security screening assessments in order to determine whether a security clearance should be granted to me.

This consent is given solely for security clearance purposes. Unless cancelled in writing by me and notification is given in writing to Health Canada, this consent shall remain valid for conducting all the necessary verifications, specified checks, assessments and/or investigations, including any subsequent required verifications, if need be, as well as any requirements for updates.

I certify that all the information set out by me in this application for a security clearance, including any supporting documentation, is true and correct to the best of my knowledge and belief.

Applicant's Name (print in block letters):

Date (YYYY/MM/DD):

Applicant's Signature:

Home telephone:

Work telephone:

Privacy Notice Statement

The personal information you provide on this form to Health Canada is governed in accordance with the Privacy Act. This Notice explains the purposes of the collection and use of the personal information you provide on this form. We only collect the information required for a security clearance as part of the application pursuant to the Cannabis Regulations. Security clearance is a requirement under the Cannabis Regulations for issuance of a licence. A refusal to provide the information requested on this form will result in a refusal to process the application. The personal information collected by Health Canada will be used to process the application. The personal information collected by Health Canada will also be disclosed to the Royal Canadian Mounted Police (RCMP) for the purpose of conducting a criminal record check and a check of the relevant files of other law enforcement agencies, including intelligence gathered for law enforcement purposes. In some cases, personal information may be disclosed without your consent for purposes not outlined here pursuant to subsection 8 (2) of the Privacy Act. A Personal Information Bank (PIB) is under development and will be included in infosource.gc.ca. You have the right to request access to and correction of your personal information. For more information about these rights, or about our privacy practices, please contact the Privacy Management Division at 613-946-3179 or HC.privacy-vie.privee.sc@canada.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.

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, it is anticipated that the decision-making function would not be exercised personally by the Minister, but instead by an official in the Department of Health who has been delegated that responsibility in accordance with the Salaries Act.

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Footnote 2

Sale for medical purposes

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Footnote 3

For analytical testing and research licence applications, a copy of Government Issued ID will be required in order to verify the identity of the applicant. Refer to section 6.10 of this guide for more information.

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Footnote 4

Indigenous affiliation can include any person or persons of First Nation, Inuit and/or Métis descent or any community, corporation or business associated with a First Nation, Inuit and Métis government, organization or community.

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