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) 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:

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).

Important: Notifying Health Canada of a new cannabis product does not constitute approval for sale by Health Canada, nor does it mean that the product complies with legislative requirements.

It is prohibited to promote, package, or label a cannabis product in a manner that is false, misleading, or deceptive, such as stating that it has been approved by Health Canada. 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 of a potential non-compliance that may be identified.

Licence holders must ensure their cannabis products meet the requirements of the Act and the Regulations and that they comply with all applicable legislation.

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 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:

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":

Important: In the case where a processing licence holder is pending authorization to sell a class of cannabis, the licence holder may only sell the product once they are authorized to do so and once 60 calendar days have passed since a complete notice of new cannabis product was submitted to Health Canada.

Description

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

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.

Note: Photos should be representative of the cannabis product and be clearly visible.

Some tips:

  • Place the product against a white background
  • Take photos from multiple angles (such as, front, back, sides)
  • To include a photo of products such as creams, foams, or waxes, dispense them onto a surface for the photo, and pour liquids in a clear container

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.

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