Notice of new cannabis product guide: Requirements under section 244 of the Cannabis Regulations
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Purpose
This document provides guidance to processing licence holders under the Cannabis Act (the Act) on the application of section 244 of the Cannabis Regulations (the Regulations) about notices of new cannabis products. The information is based on the Regulations, as amended by the Regulations Amending Certain Regulations Concerning Cannabis (Streamlining of Requirements). It is designed to help licence holders understand and comply with the requirements and process for providing notice of new cannabis products for sale in Canada for the first time.
Scope
This guide outlines the requirements for providing advance notice of new cannabis products that are expected to be made available for sale.
The notice of new cannabis product requirements apply to processing licence holders who intend to sell a cannabis product not previously sold in Canada.
A cannabis product is defined by subsection 1(2) of the Regulations and means cannabis that meets both criteria:
- of only 1 of the classes set out in Schedule 4 to the Act (or a cannabis accessory that contains such cannabis)
- after it has been packaged and labelled for sale to a consumer at the retail level
It does not include:
- cannabis that is intended for an animal
- a cannabis accessory that contains cannabis that is intended for an animal
- a drug containing cannabis
Section 244 does not require notification for products that are dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds.
Note: Co-packed products do not require notification. Only the immediate container within a co-pack requires notification.
Important: Notifying Health Canada of a new cannabis product:
- is not an approval for sale by Health Canada
- does not mean that the product complies with requirements
Licence holders cannot promote, package, or label a cannabis product in a way that is false, misleading, or deceptive. For example, stating that Health Canada has approved the product. Contravening this prohibition can lead to compliance and enforcement actions.
Licence holders should not expect any communication from Health Canada after submitting a notice of new cannabis product. However, Health Canada may contact licence holders for more information or to inform them of a potential non-compliance.
Licence holders must ensure:
- their cannabis product meets the requirements of the Act and the Regulations
- they comply with all applicable legislation
Notice: New cannabis product
Licence holders must submit the following information in their notice at least 60 calendar days before making the new cannabis product available for sale:
- the cannabis class (either edible cannabis, cannabis extract and cannabis topical, as defined in subsection 1(1) of the Regulations)
- the date on which the licence holder expects to make the cannabis product available for sale
- a description of the product, including the brand name
The description should include the key information that distinguishes a new cannabis product, including:
- brand name or any other brand element (as defined in the subsection 2(1) of the Act)
- intended use (for example, inhalation, ingestion, topical)
- cannabis product form (for example, joint (pre-rolled), vaping liquid, capsule, spray, confectionary, beverage, cream, lotion)
- accessory that contains cannabis
- net weight and number of units per immediate container (as defined in subsection 1(2) of the Regulations)
- total THC and CBD concentration in milligrams per gram as displayed on the label, and any other cannabinoids, their concentration or amount
- ingredients (as defined in subsection 1(2) of the Regulations) in the cannabis product as listed on the label
- anything else that significantly distinguishes the product (for example, nano- or biotechnology based, re-introduced terpenes, novel cannabinoids)
- sensory attributes of the product such as the flavour, scent, colour and shape of the product
For a notice of new cannabis product, a new cannabis product is one that is distinct from other cannabis products sold by the processing licence holder. If a licence holder changes any of the characteristics listed above, the product may:
- be considered a new cannabis product
- require a new notice
Batch to batch variability in line with the Regulations is not considered a change and notification by licence holders is not required.
Submitting a notice of new cannabis product
Licence holders should use the Cannabis Tracking and Licensing System (CTLS) to notify Health Canada of their intent to sell a new cannabis product. Processing licence holders can access the "Notice of New Cannabis Product" section within the CTLS to submit the required information.
Licence holders cannot edit a notice once it is submitted. If a licence holder wishes to make changes, they must submit a new notice. There is no fee associated with the Notice of new cannabis product process.
Submitting a notice in the CTLS
The CTLS contains fields to provide the required information as part of the notice of new cannabis product, which include:
General information section
- Licence ID: Licence associated with the licence holder who is selling the cannabis product
- Company product identifiers (if applicable): Any identifiers used by the company for internal purposes.
- Do not include any brand name in this field
- For example, a Stock Keeping Unit (SKU) or Global Trade Item Number (GTIN)
- Brand name: The cannabis product's name that is proposed to be sold.
- It should distinguish the product from all others available on the retail market. Each brand name is considered a distinct product
- For example, "Sour Diesel"
- Pending licence amendment to authorize for sale: Licence holder should select "yes" if they have conditions on their licence that do not authorize them to sell the class of cannabis being notified
Important: In the case where the licence holder is pending authorization to sell a class of cannabis, they may only sell the product once both the following criteria are met:
- they are authorized to do so
- 60 calendar days have passed since they submitted a complete notice of new cannabis product to Health Canada
- Date of expected sale: A date at least 60 calendar days from the date the licence holder submits the notice
- Class of cannabis: Class of cannabis as
- The classification of cannabis is based on Schedule 4 to the Act.
- A notice is only required for edible cannabis, cannabis extracts and cannabis topicals. A notice is not required for dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds.
- A cannabis product can only belong to 1 class of cannabis. For example, a cannabis product cannot be edible cannabis and a cannabis extract at the same time.
- Refer to Classification of ingestible cannabis for more information on the classification of edible cannabis and cannabis extracts.
Description section
- Intended use: Intended use of the product.
- For example, inhalation, ingestion, or use on the body or hair.
- There is a list of possible intended uses in the CTLS. If the intended use is not reflected in the list, licence holders can provide their own by selecting "Other".
- The intended use should be consistent with what is on the product label. Refer to Packaging and labelling guide for cannabis products for more information about requirements.
- Cannabis product form: Cannabis product's common name or function.
- For example, vaping liquid, capsule, beverage, kief.
- There is a list of possible cannabis product forms in the CTLS. If the form is not reflected in the list, licence holders can provide their own by selecting "Other".
Note: In respect to edible cannabis, "common name" has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations.
- Accessory that contains cannabis:
- Licence holder should describe:
- the accessory if it contains one
- for example, infused pre-rolled joints or a vape cartridge
- the dispensing mechanism if it has one
- the accessory if it contains one
- The description should include characteristics such as the colour and shape.
- Licence holder should describe:
- Net weight and number of units per immediate container
Note the following definitions:
- Discrete unit: For a cannabis product with a single immediate container that contains more than 1 unit. Each of the units within the immediate container is considered a discrete unit. For example, an immediate container with multiple capsules, each capsule is considered a discrete unit.
- Not in discrete units: For a cannabis product with a single immediate container that contains only 1 unit. The entire package with the 1 unit is considered not in discrete units. For example, a cannabis extract tincture in a single bottle or a cannabis-infused beverage.
- Total net weight of immediate container:
- For cannabis products containing multiple discrete units: The total net weight should reflect the sum of all discrete units in the immediate container
- For example, a container with 20 capsules each weighing 1 g has a total net weight of 20 g.
- For cannabis products not in discrete units: The total net weight in the immediate container should be provided.
- For example, a cannabis infused beverage has the total net weight of 355 g in the immediate container.
- For cannabis products containing multiple discrete units: The total net weight should reflect the sum of all discrete units in the immediate container
- Net weight unit: The unit of measurement for the cannabis product (for example, g, mg)
Note: For cannabis products in liquid form, please provide net weight units in grams or milligrams.
- Number of units per immediate container:
- For cannabis products containing multiple discrete units: Provide the number of discrete units in the immediate container
- For example, 20 capsules, 10 pre-rolled joints, 5 gummies.
- For products not in discrete units: Enter the number of units as "1"
- For cannabis products containing multiple discrete units: Provide the number of discrete units in the immediate container
- Net weight per unit:
- For cannabis products containing multiple discrete units: The net weight or volume per discrete unit will be calculated based on the total net weight divided by the number of units per immediate container
- For example, a package has 20 capsules of 1 g each, the total net weight is 20 g
- For cannabis products not in discrete units: The net weight per unit will be the same as the total net weight of the immediate container
- For cannabis products containing multiple discrete units: The net weight or volume per discrete unit will be calculated based on the total net weight divided by the number of units per immediate container
- Cannabinoids: Total THC and CBD concentration (in milligrams per gram) and quantity that will appear on the product label should be provided. If any other cannabinoids are displayed on the product label, licence holders should provide their name, concentration or amount.
- Concentrations takes into account the potential to convert, for example:
- THCA into THC
- CBDA into CBD
- CBGA into CBG
- Concentrations takes into account the potential to convert, for example:
- Ingredients (as per label): The ingredients required to be on the product label under the Regulations
- Licence holders should write the ingredients as they will appear on the product label (for example, they may be copied and pasted directly from the label, separated by commas).
- Changes to the ingredients on the label would be considered a new product and would require a new notice to be submitted.
- Refer to Guide on composition requirements for cannabis products for the key regulatory requirements relating to the formulation, production, and composition of cannabis products.
- Refer to Packaging and labelling guide for cannabis products for more information about the packaging and labelling requirements for cannabis and cannabis products.
- Restricted ingredients: Ingredients contained in the cannabis product that are restricted (for example, a cannabis topical with ingredients found on the Cosmetic Ingredients Hotlist or prohibited or restricted by the Regulations)
- Licence holders should identify the ingredient using the drop-down list provided and include their quantity.
- Refer to Guide on composition requirements for cannabis products for more information regarding the formulation, production, and composition of cannabis products.
- Additional information: Anything else that significantly distinguishes the product or makes it novel.
- This could include a product that is:
- nano-formulated or biotechnology-based
- synthetically produced through biotechnological means or otherwise
- genetically engineered
- a new phytocannabinoid derivative or isomer of cannabis
- re-introduced terpenes
- For more information on novel products, refer to Guide on composition requirements for cannabis products.
- This could include a product that is:
- Sensory attributes: Such as flavour, scent, colour or shape of the cannabis product. For example:
- flavour: lemon
- scent: lemon
- colour: yellow
- shape: circular
The photos provided of the cannabis product should supplement the description of the sensory attributes.
Documentation section
- Photos: Photos should support the description of the product. Include photos of:
- the final packaged and labelled product
- the product's packaging
- the product's label
- the product's immediate container (for example, the cartridge, chocolate, lotion)
- A photo of the product itself
Note: Photos should be representative of the cannabis product and be clearly visible.
- Place the product against a white background
- Take photos from multiple angles (such as, front, back, sides)
- For creams, foams, or waxes, dispense them onto a surface for the photo,
- For liquids, pour it in a clear container
The total file sizes of all photos and supplementary information uploaded into the CTLS cannot exceed 10MB. Licence holders should use low-medium photo resolution so long as the product is visible. If the licence holder exceeds this amount, email notice-cannabis-avis@hc-sc.gc.ca for further instructions.
Viewing a Notice of new cannabis product
Licence holders can access the "Notice of new cannabis product" section within the CTLS to view draft or submitted notices.
Withdrawing a Notice of new cannabis product
License holders can withdraw their own notice via the "Notice of new cannabis product" section within the CTLS.
Withdrawing a notice means that the licence holder has retracted their submission such that it is deemed never to have been made, and the product has not been notified to Health Canada. If the licence holder later decides to make the product available for sale, they must submit a new notice in accordance with regulatory requirements.
Retention period
The licence holder must retain a copy of the notice for at least 2 years after the date on which the cannabis product is expected to be made available for sale, as per subsection 244(2) of the Regulations.
Contact us
For questions specifically related to notices of new cannabis products, email notice-cannabis-avis@hc-sc.gc.ca.
For a more complete list of Government of Canada contact information, refer to Cannabis and industrial hemp contact information for licence holders, applicants and industry.
Disclaimer
This document is not part of the Cannabis Act or its regulations. Licence holders should read this with the relevant sections of the Act and its regulations. The information on this page is not intended to substitute for, supersede or limit the requirements under the legislation. In the event of discrepancy between the legislation and this document, the legislation will prevail.
The reader is advised to consult other legislation that may apply to them or their activities, such as provincial or territorial legislation.
This document may be updated periodically so the reader is encouraged to check the latest version.