Before you start applying for a cannabis drug licence

On this page

• Determine if you require a licence
• Familiarize yourself with the legislation
• Self-identify as an Indigenous affiliated applicant
• Prepare your site
• Identify people

This page provides the information you should consider before applying for a licence.

Determine if you require a licence

Before applying for a licence, determine if you require a cannabis drug licence for your intended activities.

A cannabis drug licence allows you to work with drugs containing cannabis. This licence allows you to:

• possess cannabis
• produce drugs containing cannabis
• sell or distribute drugs containing cannabis
• research and development within the authorized activities

This licence doesn’t allow you to administer cannabis or drugs containing cannabis to a human research subject. If you want to do this, you need to apply for a research licence and in some cases clinical trial authorization. If you want more information about this, refer to the Cannabis licensing application guide: Research.

You can’t add a cannabis drug licence by amending your existing licence. You need to start a new licence application specifically for a cannabis drug licence in the Cannabis Tracking and Licensing System (CTLS).

Drug establishment licence

In most cases, you’ll need a drug establishment licence and a cannabis drug licence for your intended activities.

If you already hold a drug establishment licence, you do not need to apply for a new drug establishment licence. However, you may need to amend your drug establishment licence to include new sites and activities. All sites and activities that require a drug establishment licence must be listed on the licence document. Refer to Drug establishment licence application: forms and instructions for how to amend your drug establishment licence.

If you need a drug establishment licence, you should apply for one before or at the same time as for your cannabis drug licence. For questions about this type of licence or to confirm if you require one, refer to the Guidance on drug establishment licences or contact hpfb_cannabis_dgpsa@hc-sc.gc.ca.

Familiarize yourself with the legislation

Familiarize yourself with the legislation listed below to see how they apply to your application.

• Cannabis Act and its regulations, including the Cannabis Regulations
• Legislation in your province or territory
• Your municipality’s or local government’s laws, by-laws, policies

These laws, among others, could also apply to you:

• Food and Drugs Act
• Pest Control Products Act
• Tobacco and Vaping Products Act
• Controlled Drugs and Substances Act

Self-identify as an Indigenous affiliated applicant

Indigenous affiliation can include:

• any person or persons of First Nation, Inuit or Métis descent
• any community, corporation or business associated with a First Nation, Inuit and Métis government, organization or community

Self-identification is optional.

Health Canada offers the Navigator services to guide Indigenous affiliated applicants through the licensing process, and once they’ve become a licence holder.

There’s a section to identify your application as Indigenous affiliated in the CTLS. Once this section is filled out in the CTLS, the Navigator service will reach out to you for an introductory teleconference after you’ve submitted your licence application.

If you’d like help before submitting your licence application, or if you have any questions about applying as an Indigenous affiliated applicant, email navigator-navigateur@hc-sc.gc.ca.

Prepare your site

You need to show that your site is fully built and meets all the requirements with security measures in place when you submit your licence application.

The following section describes the things you should consider when preparing your site details for your proposed site.

A site is defined as an area that’s used exclusively by the licence holder that consists of at least 1 building or 1 part of a building. You need to have at least 1 building on your site when you submit your licence application.

Site perimeter

You need to define the site perimeter for your site. Only the licence holder can do activities on the site. If someone other than the licence holder uses any areas, rooms or buildings, they need to be outside of the proposed site perimeter.

Licences are site specific

If you’re planning to do licensed activities at more than 1 site, submit a separate licence application for each site.

Multiple licence holders at 1 location

There isn’t a limit to the number of licence holders on a single piece of land or in a building. More than 1 licence holder is allowed if each licence holder is within a separate site or defined site perimeter. If there are multiple licence holders at 1 location, each licence holder will need to keep their activities separated between each site. For example, each licence holder will need to:

• have a unique civic or mailing address for each licensed site for keeping shipping, receiving and mail delivery separated
• keep separate record-keeping documents

If there are multiple licence holders at 1 location, Health Canada will assess the risks associated with the increased amount of cannabis on each site. This can happen during the application process or after licensing, based on your current or future proximity to other licence holders. If the co-location of licences increases risks, we may add or revise conditions on your licence, or require more physical security measures for the site.

Storage areas

You should have enough storage areas to handle your intended activities and amount of cannabis that will be at the site. You’ll need to have storage for:

• viable cannabis seeds
• any part of a cannabis plant, including the phytocannabinoids produced by, or found in the cannabis plant, processed or not
• any substance or mixture of substances that contains or has on it any part of a cannabis plant
  • for example, drugs containing cannabis
• any substance that is identical to any phytocannabinoid produced by, or found in a cannabis plant regardless of how you obtained the substance

The following aren’t considered cannabis and don’t need to be stored in the storage area:

• non-viable seeds
• roots or any part of the root
• mature stalks, without any leaf, flower, seed or branch
• fibres derived from a mature stalk, without any leaf, flower, seed or branch

Cannabis waste is still considered cannabis. This includes cannabis buds, leaves and branches. If you’re not destroying cannabis waste on the same day as it’s produced, you’ll have to store it in a storage area overnight.

Cannabis waste destruction

You’re not required to use a specific disposal method for cannabis. Your destruction method will have to meet section 146 of the Cannabis Regulations. This includes making sure people won’t be exposed to cannabis smoke or vapour during destruction. An acceptable method can be shredding cannabis and mixing it with organic waste or soil before disposal. The destruction can be performed on site or at another location.

You need to destroy cannabis in the presence of at least 2 qualified people. At least 1 witness needs to be the senior person in charge, the qualified person in charge or the alternate qualified person in charge, and the other may be an employee of the licence holder.

If you want to send your cannabis waste to be destroyed elsewhere, you can either:

• have your qualified person in charge or their alternate, or the senior person in charge witness the destruction off site
• send your cannabis to another cannabis licence holder or a licensed dealer

Physical security

Before determining what physical security measures you need, you should determine your activities with cannabis. You’ll need to show how your site meets these requirements when you’re submitting information later in the licence application process.

If you already have a cannabis licence at your site, such as a standard cultivation, processing or medical sales licence, you may already have some physical security measures in place. You only need to submit the required information in your physical security document to demonstrate that you meet the requirements that apply to your site, based on the activities you are conducting with cannabis.

If you have a security environment that was approved under the Controlled Drugs and Substances Act and can demonstrate that you are storing cannabis in accordance with the Directive on Physical Security Requirements for Controlled Substances, you’re exempt from the Physical Security provisions in Part 4 of the Cannabis Regulations.

Use the following diagram to help you determine which physical security measures you need for your site.

Figure 2: Text description

1. You must meet the physical security measures outlined in the Directive on Physical Security Requirements for Controlled substances if:
   • you have a secured environ approved under the Controlled Drugs and Substances Act
   • you intend to securely store all cannabis at your site in accordance with the Directive on Physical Security Requirements for Controlled Substances
2. You must meet the physical security measures outlined in Division 1 of Part 4 of the Cannabis Regulations if:
   • Either:
   • you have a secured environ approved under the Controlled Drugs and Substances Act
   • you do not intend to securely store all cannabis at your site in accordance with the Directive on Physical Security Requirements for Controlled Substances
   • the amount of cannabis that will be sold or distributed to you is more than 600 kg of dried cannabis or equivalent per calendar year
   • Or:
   • you do not have a secured environ approved under the Controlled Drugs and Substances Act
   • the amount of cannabis that will be sold or distributed to you is more than 600 kg of dried cannabis or equivalent per calendar year
3. You must meet the physical security measures outlined in paragraph 76 (1) (b) of the Cannabis Regulations if:
   • you do not have a secured environ approved under the Controlled Drugs and Substances Act
   • the amount of cannabis that will be sold or distributed to you does not exceed 600 kg of dried cannabis or equivalent per calendar year
   • you intend to conduct activities at your site involving cannabis other than analytical testing
4. You must meet the physical security measures outlined in paragraph 76 (1) (a) of the Cannabis Regulations if:
   • you do not have a secured environ approved under the Controlled Drugs and Substances Act
   • the amount of cannabis that will be sold or distributed to you does not exceed 600 kg of dried cannabis or equivalent per calendar year
   • you do not intend to conduct activities at your site involving cannabis other than analytical testing

The following table shows the physical security requirements for each scenario.

Table: Physical security requirements

Physical security measures		Division 1 of Part 4 of the Cannabis Regulations	Section 76(1)(a) of the Cannabis Regulations	Section 76(1)(b) of the Cannabis Regulations
Site perimeter and physical barrier	Perimeter designed to prevent unauthorized access	Required	Not required	Required
	Visual monitoring devices Intrusion detection system	Required	Not required	Not required
Storage areas	Physical barrier to prevent unauthorized access Access restricted to only people whose presence is required	Required	Required	Required
	Record of every person entering or exiting the storage area Visual monitoring devices Intrusion detection system	Required	Not required	Not required
Areas where storage areas are located in	Physical barrier to prevent unauthorized access Access restricted to only people whose presence is required Visual monitoring devices Intrusion detection system	Required	Not required	Not required
Operations areas	Physical barrier to prevent unauthorized access Access restricted to only people whose presence is required Visual monitoring devices Intrusion detection system	Required	Not required	Not required

Identify people

There are specific people in key roles that have to be identified in the CTLS during the application process. They need to be qualified to meet all the regulatory responsibilities. Each person needs to create an account in the CTLS, if they don’t have one already. You can identify alternates, but they also need to have a CTLS account, if they don’t have one already. Refer to the CTLS Getting Started Guide for more information.

Site personnel

The responsibilities of the site personnel include, but aren’t limited to the following:

Senior person in charge: Required

• Has the authority to bind the licence holder
• Is responsible for the management of activities with cannabis
• Knows the sections of the Cannabis Act and the Cannabis Regulations that apply to the cannabis drug licence holder
• Is the official point of contact with Health Canada
• Is responsible for submitting the licence application in the CTLS

Qualified person in charge: Required

• Is responsible for supervising the activities with cannabis
• Works at the site specified on the cannabis drug licence
• Ensures that the cannabis activities comply with the regulations
• Is present at the site when activities involving drugs containing cannabis are being conducted
• Has training, experience and technical knowledge about the use and handling of drugs required for the activities conducted
• Knows the sections in the Cannabis Act and the Cannabis Regulations that apply to the licence holder
• Meets additional requirements for the qualified person in charge

The applicant or licence holder can designate any number of alternates.

Associated individuals

Consent to communicate

You may also choose to identify other associated individuals in the CTLS during the licence application process. You can identify someone who’s allowed to communicate with Health Canada about your application and licence. For example, it can be given to a lawyer, a consultant, or another person associated with the application other than the senior person in charge.

This role is optional. Each person added needs to create an account in the CTLS.