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Prepare your information for a cannabis licence application: Cultivation, processing and sale for medical purposes with possession of cannabis licence

On this page

  1. 1.0 CTLS submission information
    1. 1.1 For corporations, cooperatives or partnerships
    2. 1.2 Site details
    3. 1.3 Identified people
    4. 1.4 Site ownership
    5. 1.5 Organizational security plan
    6. 1.6 Good production practices
    7. 1.7 Record keeping
    8. 1.8 Key investor reports
    9. 1.9 For cultivation licences: Sources of starting material
  2. 2.0 Site evidence package
    1. 2.1 How to format
    2. 2.2 What to prepare
  3. 3.0 Forms and template

This page describes what you need to prepare before you can submit it in the Cannabis Tracking and Licensing System (CTLS) and in the site evidence package. This page only applies to these licences:

For information on applying for sale for medical purposes without possession of cannabis licences, refer to Prepare your information: Sale for medical purposes without possession of cannabis licences.

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

1.0 CTLS submission information

Generally, the information you need to submit in the CTLS is the same for these licences. It will be clearly indicated if the section doesn't apply to a licence.

1.1 For corporations, cooperatives or partnerships

You'll have to create a corporate profile in the CTLS, if you don't already have one, if you're applying for the licence as:

This section provides the information you need to prepare when you're creating a new corporate profile.

1.1.1 Parent (owning) corporation

Any controlling corporation is required to create a corporate profile, and directors and officers of that corporation need to apply for security clearances.

Who needs a security clearance

You need to gather the CTLS Account IDs of any controlling corporation, if applicable.

1.1.2 Certificate of incorporation or business registration document

You need to prepare the following document depending on your organization.

1.1.3 Directors, officers, partners

You need to gather the CTLS Account IDs of all your directors, officers and partners.

1.2 Site details

This section provides information on what you need to prepare about your site.

Important: If you'll be conducting Health Canada-regulated cannabis activities in First Nations, Inuit or Métis communities, email navigator-navigateur@hc-sc.gc.ca.

1.2.1 Health Canada licences, registrations and authorizations

You need to prepare information about licences, registrations and authorizations issued to the applicant from Health Canada for the same site. This can include information about any:

For each licence, registration or authorization, submit:

If the applicant doesn't have any licences, registrations and authorizations issued by Health Canada, indicate this in the document.

1.2.2 Aerial view

You need to prepare a clear and legible aerial view of the proposed site and surrounding area.

Note: A web mapping service, such as Google Maps, is enough for an aerial view. It needs to show an accurate and up to date proposed site and surrounding 500 metre radius.

1.2.3 For a site with multiple addresses

If your site has multiple addresses, such as an area that's exclusively used by the applicant with several buildings, prepare a document listing all addresses.

1.3 Identified people

This section provides information you need to prepare about the identified people that you'll need to submit.

1.3.1 Key site personnel

You need to gather the CTLS Account IDs of all your key site personnel. Include the following personnel.

1.3.2 Associated individuals

You need to prepare information for the associated individuals, if applicable.

1.3.2.1 Consent to communicate, reporter and responsible for finance

You need to gather the CTLS Account IDs of the people who will:

For reporters and people responsible for finance, you'll need to include them in the list of all associated individuals requiring security clearances.

1.3.2.2 Associated individuals requiring security clearances, if applicable

You need to prepare a document containing a list of all associated individuals requiring security clearances (including reporters and people responsible for finance), if applicable. Include the following for each person:

1.3.3 For processing licences: Quality assurance person

This section only applies to micro-processing and standard processing licences. For each of your identified quality assurance person (QAP) and up to 2 alternates (AQAP):

Important: If you're a processor who is only conducting activities with reference standards and test kits, you do not need to have a QAP.

For the Qualifications of the proposed QAP or alternate form:

There are many ways to show how the QAP is qualified for the role. The QAP doesn't need a specific degree or diploma, or previous experience in the cannabis industry. You can show how your QAP is qualified by providing information about their quality assurance training or experience, or a combination of both in other similar fields, such as:

In the Qualifications of the proposed QAP or alternate QAP section of the form, you need to provide information about your QAP's knowledge of, experience with, and training in all the sections. This is not required if the QAP has been previously approved by Health Canada. Refer to the following examples of principles and practices you can use to show how the QAP is qualified for the role:

  1. Development and approval of SOPs (standard operating procedures)
    • Preparing SOPs, such as document creation
    • Implementing SOPs, such as:
      • training
      • document control
      • compliance and following procedures
    • Maintaining SOPs, such as updating and revising SOPs
    • Managing of a SOP program
  2. Good production practices relating to facilities, equipment, sanitation, and employee hygiene
    • Facilities, such as:
      • air filtration and ventilation
      • lighting
      • water supply
      • temperature and humidity control
      • waste disposal
    • Equipment and conveyances, such as pruning shears and forklifts
    • Design and construction of facilities and equipment allow for production under sanitary conditions
    • Sanitation programs
    • Employee hygiene SOPs
  3. Investigations and risk mitigation
    • Identifying and investigating cannabis or ingredients which pose a risk of injury to human health, for example:
      • identifying hazards and source
      • determining affected lots or batches
      • determining seriousness of issue considering the exposure and toxicity, or the severity of adverse health consequences
    • Implementing and evaluating risk mitigation measures relating to cannabis or ingredients that pose a risk of injury to human health, for example:
      • increasing the monitoring of quality indicators
      • quarantining affected lots or batches
      • conducting a recall
      • performing an effectiveness study
    • Ensuring compliance with Part 5 of the Regulations and Part 6 of the Regulations, relating to:
      • identifying non-compliances, such as:
        • reviewing of out-of-specification test results
        • assessing personnel regularly
        • performing random verification of quality processes. For example, making sure protocols or procedures, and documentation practices are followed
      • investigating non-compliances, such as performing root cause analyses
      • implementing and evaluating risk mitigation measures relating to non-compliances, such as:
        • quarantining lots or batches
        • implementing process controls
        • performing regular training programs
        • complying with limits on microbial contaminations
        • complying with limits on use of caffeine
        • complying with restrictions on ingredients in extracts
  4. Complaint management or investigation
    • Determining if a complaint is quality related, such as:
      • interviewing the person who filed the complaint
      • reassessing lot or batch production records
      • re-testing retention samples
    • Performing root cause analyses
    • Implementing and evaluating corrective and preventative actions to address the immediate situation and to prevent similar future occurrences
  5. Approving product quality prior to release for sale
    • Following procedures for releasing products for sale, such as:
      • quarantining a lot or batch temporarily
      • reviewing lot or batch production records
      • performing visual inspection
      • tracking and releasing the lot or batch
    • Determining at what stage in production to test products. For example, testing the products before or after packaging
    • Assessing documents and information when approving a product lot or batch, for example:
      • assessing test results or the Certificate of Analysis against defined specifications
      • assessing lot or batch production records, such as historical information about:
        • storage or operating conditions
        • areas used
        • name of operator or technicians
        • date of operations
        • documented sanitation records
    • Determining the criteria for approving a product lot or batch
  6. Testing
    • Understanding analytical testing and validation of testing methods, which may include assessing the following elements:
      • specificity
      • linearity
      • accuracy
      • precision
      • range
      • limit of quantification
      • limit of detection
    • Interpreting test results, relating to:
      • trending and statistical analysis, such as:
        • tracking quality indicators or attributes
        • determining outliers and significance
      • products, such as:
        • microbial and chemical contamination
        • disintegration and dissolution of cannabis capsules, if applicable, as set out in a publication referred to Schedule B of the Food and Drugs Act
        • cannabinoid content
    • Collecting samples in a representative manner
    • Retaining samples for potential lot or batch investigation
  7. Recall and adverse reaction reporting
    • Performing recalls, such as:
      • product tracking
      • analysis of distribution records
      • recall simulations
      • product reconciliation
      • effectiveness checks
      • risk based decision making
      • required notifications for stakeholders and authorities
      • recall evaluation or audit
      • plan of action
      • initiation time
    • Reporting and assessing adverse reactions, such as:
      • identifying adverse reactions and assessing whether they are product related
      • following reporting requirements

1.4 Site ownership

You need to prepare 1 of the 2 options depending on the site ownership.

Important: If you'll be conducting Health Canada-regulated cannabis activities in First Nations, Inuit or Métis communities, email navigator-navigateur@hc-sc.gc.ca.

1.5 Organizational security plan

You need to prepare a copy of your organizational security plan.

Important: The information submitted in the plan and the CTLS needs to be consistent. Discrepancies or inconsistencies can cause a delay in processing your application.

Cannabis organizational security plan

1.6 Good production practices

This section provides information you need to prepare about your good production practices (GPP) that will need to be submitted.

Important: If you're a processor who is only conducting activities with reference standards and test kits, they do not need to meet GPP.

Refer to the Good production practices guide for cannabis for how to meet good production practices requirements. It gives examples of principles and practices you can use to show your compliance.

1.6.1 Good production practices report

You need to prepare a GPP report that addresses all the information described in each of the following sections. The GPP report can be in a document with each of the sections outlined, or in separate documents.

1.6.1.1 Storage

Include the following information in your GPP report.

A description of your storage procedures. Include:

Consider where you store:

1.6.1.2 Building or part of building

Include the following information in your GPP report.

Note: Refer to Before you start applying for a licence for information about good production practices for building construction materials.

Figures 1 to 4 show an example of a process flow diagram. Do not copy this example, it's a fictional setting. These process flows can include:

Figure 1 shows how cannabis is received into the building from the Shipping / Receiving Area. Flow arrow 1 represents cannabis plants and seeds received from the Shipping / Receiving Area. It goes through Corridor 2 into 3 possible areas:

Figure 1: Process flow of receiving cannabis into the building
Figure 1. Text version below.
Figure 1 - Text description

Figure 1 shows how cannabis is received into the building from the Shipping / Receiving Area. It goes through Corridor 2 into 3 possible areas:

  • they're transferred into the Grow room 1
  • they're transferred into the Grow room 2
  • they're transferred to the Storage area

Figure 2 shows the transfer of cannabis plants and seeds within the building.

Figure 2: Process flow of growing and transferring cannabis within the building
Figure 2. Text version below.
Figure 2 - Text description

Figure 2 shows the transfer of cannabis within the building.

  • Flow arrow 2 shows the transfer from the Storage area, going through Corridor 2, into Grow room 1 or Grow room 2
  • Flow arrow 3 shows the transfer from Grow room 1, going through Corridor 2, into Grow room 2

Figure 3 shows the transfer of harvested cannabis into the operations areas and storage area in the building.

Figure 3: Process flow of processing and storing cannabis within the building
Figure 3. Text version below.
Figure 3 - Text description

Figure 3 shows the transfer of cannabis into the operations areas and storage area in the building.

  • Flow arrow 4 shows the transfer of cannabis from Grow room 1 or Grow room 2, going through Corridor 2, into the Drying room
  • Flow arrow 5 shows the transfer of cannabis from the Drying room, going through Corridor 2, into 2 possible areas:
    • the Packaging room
    • the Storage area
  • Flow arrow 6 shows the transfer of cannabis from the Storage area, going through Corridor 2, into the Packaging room
  • Flow arrow 7 shows the transfer of cannabis from the Packaging room, going through Corridor 2, into the Storage area

Figure 4 shows the transfer of packaged and labelled cannabis and cannabis waste out of the building.

Figure 4: Process flow of shipping cannabis out of the building
Figure 4. Text version below.
Figure 4 - Text description

Figure 4 shows the transfer of cannabis out of the building.

  • Flow arrow 8 shows the transfer of cannabis from the Storage area, going through Corridor 2 and the Shipping/Receiving area, out of the building
  • Flow arrow 9 shows the transfer of cannabis from all the operations areas and storage area, going through Corridor 2 and the Shipping/Receiving area, out of the building
1.6.1.3 Filtration and ventilation system

Include the following information in your GPP report.

Figure 5 shows an example of a filtration and ventilation diagram. Do not copy this example, it's a fictional setting.

Figure 5: Air filtration and ventilation diagram
Figure 5. Text version below.
Figure 5 - Text description

The air is drawn into the building through a HEPA (high-efficiency particulate air) filter, before circulating through the duct openings and duct vents into the Storage area, Packaging room, Drying room, Grow room 1 and Grow room 2. There are also portable carbon filters in these areas. The air is drawn out from these areas through the duct openings, duct vents, and a carbon filter before it's exhausted outside of the building.

For more information about cannabis odours, odour control technologies and Health Canada's role in regulating cannabis odours in commercial production sites, refer to Cannabis odours and odour control.

1.6.1.4 Supply of water

Include the following information in your GPP report.

Note: Refer to Before you start applying for a licence for information about good production practices for water sources when processing cannabis extracts, edibles and topicals.

1.6.1.5 Lighting

Include the following information in your GPP report.

1.6.1.6 Sanitation program

Include the following information in your GPP report.

1.6.1.7 Hand cleaning and hand sanitizing stations and lavatories

Include the following information in your GPP report.

1.6.2 For processing licences: Good production practices attestation

You need to fill out the Good production practices attestation.

1.7 Record keeping

This section provides information you need to prepare about record keeping that will need to be submitted.

1.7.1 Record keeping attestation

You need to fill out the Record keeping attestation.

1.7.2 For sale for medical purposes licences: Proposed record keeping methods

You need to prepare the following.

Note: To be compliant with the Regulations, your process must verify that the medical document contains the following information:

  • health care practitioner's name, business address and phone number
  • province where the health care practitioner is authorized to practice and their licence number
  • name and date of birth of the patient
  • address of the location where the patient consulted with the health care practitioner
  • daily quantity of dried cannabis (in grams), authorized by the health care practitioner
  • period of use, up to 1 year (number of days, weeks or months)
  • signature and date of the health care practitioner and a statement that the information in the medical document is correct and complete

1.8 Key investor reports

You need to prepare either a report or an attestation about key investors. Refer to Cannabis key investors for more information about the requirements for applicants:

1.9 For cultivation licences: Source of starting material

This section only applies to micro-cultivation, nursery and standard cultivation licences.

You can receive starting materials (cannabis plants and seeds) that were obtained:

You can also receive starting materials from a source that is not listed above, on an exceptional basis. You'll need to submit a declaration under subsection 10(2) of the Regulations for your licence application. It needs to:

Before Health Canada and the Canada Revenue Agency (CRA) issue your licence:

Important: If you possess more cannabis starting material than what you've declared, or do any activities other than the ones you're allowed, it may result in enforcement actions from Health Canada and the CRA, such as financial penalties or seizure of material.

Once Health Canada and the CRA issue your licence:

All cannabis produced under the licence, regardless of its original source need to meet Part 5 of the Regulations and Part 6 of the Regulations.

2.0 Site evidence package

Note: Health Canada recommends that you develop your site evidence package at the same time as completing your application in the CTLS.

The site evidence package needs to show that your site is fully built and meets the physical security measures and the good production practices of the Regulations. This includes submitting evidence to show that you have an operational and functional site. For example, a building equipped with all permanent fixtures, such as:

For examples of principles and practices that you can use to show compliance for your fully built site, use:

The requirements for an operational and functional site only apply to the areas of your site where you plan to conduct activities with cannabis when you first get your licence. For example, if you'll only use some areas of the building, then you're only required to submit site evidence for the areas you'll use and would like to be approved, instead of the entire building.

You aren't required to submit any information on your cultivation and processing equipment or have it present during the site evidence video walkthrough. This includes your:

2.1 How to format

You need to prepare the site evidence package using the following format.

You don't have to use any professional or special equipment to produce your footage. You can use a smart phone or a camera. Just make sure you have good lighting, so that the features in the video recording are clearly visible.

2.2 What to prepare

The site evidence package you have to submit for micro-cultivation, nursery and micro-processing licences are different from that for standard cultivation, standard processing and sale for medical purposes with possession of cannabis licences. The main difference is the different physical security requirements you have to meet.

Important: If you're applying for a micro-cultivation, nursery or micro-processing licence together with:

  • a sale for medical purposes with possession of cannabis licence, you need to meet the physical security requirements for both licences, and will have to submit your physical security information in your site evidence package to show this
  • a sale for medical purposes without possession of cannabis licence, you don't need to meet the extra physical security measures

2.2.1 For micro-cultivation, nursery, and micro-processing licences

This section provides information about what you need to prepare for your site evidence package for micro-cultivation, nursery and micro-processing licences.

2.2.1.1 Site plan (includes storage areas)

You need to include the following information in your site plan.

2.2.1.2 Floor plans

Prepare floor plans for each building on your site where cannabis activities will take place. You can submit multiple floor plans to show different information. For example, a floor plan showing only the grow surface areas information or the cannabis flow information only. In each building's floor plan, include the following.

2.2.1.3 For micro-cultivation and nursery licences: Grow surface areas
2.2.1.4 Physical barrier and site design

You need to prepare the following information.

2.2.1.5 Restricted access

You need to prepare the following information.

2.2.1.6 Guided video tour

You need to include the following information in the guided video tour of the site.

2.2.1.7 Physical security measures attestation

You need to fill out the Physical security measures attestation.

2.2.2 For standard cultivation, standard processing and sale for medical purposes with possession of cannabis licences

This section provides information about what you need to prepare for your site evidence package for a standard cultivation, standard processing and a sale for medical purposes with possession of cannabis licences.

2.2.2.1 Site plan (includes storage areas)

You need to include the following information in your site plan.

2.2.2.2 For outdoor areas (security devices)

You need to include the following information (can be on the site plan).

2.2.2.3 Floor plans

Important: Your floor plan needs to include all areas and rooms, even if there are no activities with cannabis occurring inside. For example, lavatories and transitory areas such as hallways.

You need to prepare floor plans for each building on your site where cannabis activities will take place. You can submit multiple floor plans to show different information. For example, a floor plan showing only the security device information or the cannabis flow information only. In each building's floor plan, include the following.

2.2.2.4 Physical barrier and site design

You need to prepare the following information.

2.2.2.5 Visual monitoring devices

You need to prepare the following information.

2.2.2.6 Intrusion detection devices

You need to prepare the following information.

2.2.2.7 Restricted access

You need to prepare the following information.

2.2.2.8 Access log

You need to prepare information on how access (entry and exit) will be logged for all doors leading to and from storage areas. Include the following:

You don't need to submit the actual reports.

2.2.2.9 Guided video tour

You need to include the following information in the guided video tour of the entire site.

2.2.2.10 Physical security measures attestation

You need to fill out the Physical security measures attestation.

3.0 Forms and template

Attestations required in completing your licence application:

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