Notice of new cannabis product guide: Requirements under section 244 of the Cannabis Regulations

On this page

• Purpose
• Scope
• Disclaimer
• Notice: New cannabis product
  • Submitting a notice in the CTLS
  • Retention period
• Contact us

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) respecting notice of new cannabis products. It is designed to help licence holders understand and comply with the requirements and process for providing notice of new cannabis products to be sold 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.

As per section 244 of the Regulations, the notice of new cannabis product requirements only apply to processing licence holders who intend to make available for sale a cannabis product that they have not previously sold in Canada.

A cannabis product is defined by subsection 1(2) of the Regulations and means cannabis of only one 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

Notification under section 244 is not required in respect of products that are dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds. Additionally, a notice is only required for the immediate container in a co-pack, not for the co-packed product itself.

The information in this guide is based on the Regulations, as amended by the Regulations Amending Certain Regulations Concerning Cannabis (Streamlining of Requirements).

Disclaimer

This document does not constitute part of the Cannabis Act or its regulations. It should be read in conjunction with the relevant sections of the Act and its regulations. The information in this document 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 shall prevail.

The reader is advised to consult other legislation that may apply to them or their activities, such as applicable provincial or territorial legislation.

This document may be updated periodically so the reader is encouraged to check the latest version.

Notice: New cannabis product

Notification under section 244 is not required in respect of products that are dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds.

As per section 244 of the Regulations, 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 (as per Schedule 4 to the Act) (either edible cannabis, cannabis extract and cannabis topical, as defined in the Regulations)
• the date on which the cannabis product is expected to be made available for sale
• a description of the product, including the brand name

The description should include the key information that would distinguish a new cannabis product, as noted below. For example, the description should include information such as:

• brand name or any other brand element (as defined in the Act)
• intended use (for example, inhalation, ingestion, topical)
• cannabis product form (for example, infused pre-rolls, vaping liquid, capsule, spray, food formats, beverages)
• accessory that contains cannabis
• net weight or volume and number of units per immediate container (as defined in the Regulations)
• total THC and CBD concentration (in milligrams per gram) or quantity per discrete unit, as displayed on the label, and any other cannabinoids, their concentration or amount
• ingredients (as defined in 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)
• sensory attributes of the product such as the flavour, scent, colour and shape of the product

For the purpose of 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 and a new notice could be required. Batch to batch variability in accordance with the Regulations is not considered a change, and licence holders do not need to notify of these.

Licence holders are invited to contact Health Canada at notice-cannabis-avis@hc-sc.gc.ca if they are uncertain as to when a proposed new product requires notice to Health Canada or for any questions related to Notice of new cannabis products.

The Cannabis Tracking and Licensing System (CTLS) should be used to notify Health Canada of the intent to sell a new cannabis product. Processing licence holders will be able to view the "Notice of new cannabis product" section within the CTLS and submit the required information. They will also be able to view certain information for all their previously submitted notices. Changes to a submitted notice cannot be made. Instead, if a licence holder wishes to modify a notice, a new one must be submitted.

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. The fields are divided into multiple sections, as outlined below.

General information

The following fields are found in CTLS under the first section, "General information":

• Licence ID: The licence associated with the licence holder who is selling the cannabis product.
• Company product identifiers (if applicable): May be used by the company, if desired, to refer to any identifiers used by the company. For example, a Stock Keeping Unit (SKU) or Global Trade Item Number (GTIN).
• Brand name: The brand name under which the cannabis product is proposed to be sold. It should distinguish the product from all others available on the retail market. For example, a brand name could be "Sour Diesel". Each brand name is considered a distinct product.
• Pending licence amendment to authorize for sale: When a processing licence holder has conditions on their licence that do not authorize the processing licence holder to sell the class of cannabis being notified, "pending licence amendment to authorize for sale" should be indicated by selecting "yes" in this field.

• Date of expected sale: The date of expected sale must be indicated in the CTLS. The date of expected sale must be at least 60 days from the date the notice is submitted.

• Class of cannabis: Used to identify the class of cannabis as per Schedule 4 to the Act (for example, edible cannabis, cannabis extract, cannabis topical). A notice is not required for products that are dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds. By definition, a cannabis product can only belong to one class of cannabis. For example, a cannabis product cannot be edible cannabis and a cannabis extract at the same time. The classification of cannabis is based on the definitions set out in the Act and the Regulations.

  Refer to Classification of edible cannabis for more information on the classification of edible cannabis and cannabis extracts.

Description

The following fields are found in CTLS under the second section, "Description":

• Intended use: Indicate the intended use of the product. For example, if the product is intended for inhalation, ingestion, or for use on the body or hair. Health Canada has provided a list of possible intended uses within the CTLS. Licence holders have the option to input their own by selecting "Other" if the intended use of their product is not reflected in the list provided. 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 the packaging and labelling requirements for cannabis and cannabis products.
• Cannabis product form: The identity of the cannabis product in terms of its common name or in terms of its function should be provided. For example, vaping liquid, capsule, beverage, kief. Health Canada has provided a list of possible cannabis product forms within the CTLS. Licence holders have the option to input their own by selecting "Other" if the cannabis product form of their product is not reflected in the list provided.

  Note: In respect of 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: If the cannabis product is composed of an accessory that contains cannabis, such as in the case of infused pre-rolled joints or a vape cartridge, the accessory should be described. The description should include characteristics such as the colour and shape. If the product contains an integrated dispensing mechanism this should also be indicated.

• Net weight or volume and number of units per immediate container: Include whether the product is in discrete units or not in discrete units.

  Note: A discrete unit refers to, in the case where a single immediate container contains more than 1 unit of a cannabis product, each of those units. Examples could include but are not limited to multiple infused pre-rolled joints, capsules, separate edible pieces.

  • For cannabis products containing multiple discrete units: The net weight in grams per discrete unit in the immediate container should be provided (for example, net weight per capsule is 1 g) as well as the number of discrete units in the immediate container (for example, 20 capsules) and the net weight of the cannabis product in the immediate container (for example, net weight of the cannabis product in the immediate container is 20 g).
  • For cannabis products not in discrete units (for example, a vial of cannabis extract): The net weight or volume of cannabis in the container should be provided (for example, net volume in the immediate container is 5 mL).
• Cannabinoids: THC and CBD concentration (in milligrams per gram) or quantity per discrete unit. The concentration or quantity that will appear on the label should be provided. If any other cannabinoids are displayed on the product label, their name, concentration or amount should also be provided.
  • The following fields may be provided when submitting THC and CBD values in CTLS:
    • Quantity: This field should be used to document the THC and CBD values, not taking into account the potential to convert THCA into THC, and CBDA into CBD, respectively.
    • Total Quantity: This field should be used to document the THC and CBD values, taking into account the potential to convert THCA into THC, and CBDA into CBD, respectively.
  • For other cannabinoids, the "Quantity" value should be interpreted as the total quantity of the cannabinoid, taking into account the potential to convert the acid form into the cannabinoid (for example, CBGA into CBG).
• Ingredients (as per label): The ingredients required to be on the product label under the Regulations are to be submitted. The ingredients provided in the notice should be written 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 are indicative of 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: If any of the ingredients contained in the cannabis product are restricted (for example, a cannabis topical with ingredients found on the Cosmetic Ingredients Hotlist or prohibited/restricted by the Regulations), they should be identified using the drop-down list provided and their quantity should be included. 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 should be described. 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, and re-introduced terpenes, among others. For more information on novel products, refer to Guide on composition requirements for cannabis products.
• 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

The following fields are found in CTLS under the third section, "Documentation":

Photos of the cannabis product should be provided by the licence holder to support the description. The cannabis product includes the packaged/labelled final product. In that respect, photos of the package and of the label should be provided. Additionally, photos of the cannabis product's immediate container within the labelled package (for example, the cartridge, chocolate, lotion) should be included. If the cannabis product is part of a co-pack, there is no requirement to submit a photo of the outer container.

As noted earlier, submitting this information in the notice does not imply that Health Canada has reviewed or approved the product, including the packaging or labelling. Licence holders are responsible for making sure their cannabis products meet the requirements of the Act and the Regulations and that they comply with all applicable legislation.

The total file sizes of all photos and supplementary information uploaded into the CTLS cannot exceed 10MB. Thus, for multiple photos, low-medium photo resolution should be used so long as the product is visible. Should there be information that exceeds this amount, please contact notice-cannabis-avis@hc-sc.gc.ca.

Retention period

The licence holder must retain a copy of the notice for at least two 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 Notice 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.