Program update: Changes to the process of adding sale authorization of cannabis products to processing licences

As part of its efforts to continuously improve the cannabis program, Health Canada is announcing the following program change effective October 1, 2023.

Health Canada will phase out inspections for authorized activities change requests to add the activity of sale of extract, edible, and topical cannabis products. This applies to all micro and standard processing licence holders.

The requirement to submit an authorized activities change request to add the activity of sales and application process remain in place for these classes of cannabis products. Licence holders will continue to submit an authorized activities change in the CTLS.

The following submission requirements will no longer be required as part of the authorized activities change request:

• Inner and outer labels
• Photos of your entire lots
• Completed packaging records
• Master list of standard operating procedures
• Evidence that packaging meets the child resistance requirements
• Proof that each lot or batch has been tested using validated test methods including evidence that test methods have been validated for the appropriate class of cannabis
  • For example, method validation reports

Note: While these are no longer required as part of the authorized activities change request, licence holders will still need to meet these regulatory requirements. This can be verified during subsequent inspections.

An inspection will no longer be required prior to the issuance of an amendment to a processing licence to authorize the sale of extract, edible and topical cannabis products.

Licence holders who are granted the authorization to sell will be prioritized for regular inspections using a risk-based approach.

Manage your cannabis licence will be updated in the future to reflect these changes.

In addition, Health Canada will end the in-person compliance promotion session provided to licence holders seeking to add the activity of sale to their processing licence. It will be replaced with compliance promotion material that will be accessible online.

The decision for the above program changes was part of several progressive changes made to Health Canada’s approach to the authorization of sale activities for licence holders. No changes are being made to the regulatory requirements.

Licence holders will continue to submit their Notification of New Cannabis Product (NNCP) 60 days prior to selling extract, edible and topical cannabis products to provincially and territorially authorized retailers and sale for medical purposes licence holders once their licence has been amended.

Licence holders must also continue to ensure that all cannabis produced and sold meets the requirements of the Cannabis Regulations, including:

• Packaging and labelling requirements
• Good production practices, including pesticide testing requirements
• Having a quality assurance person to assure the quality of cannabis prior to sale.

These changes will reduce regulatory burden on licence holders and give licence holders the ability to bring products to market more quickly. Health Canada will continue to provide oversight using a risk- based approach.

No action is required on the part of licence holders or licence applicants. In-process authorized activities change requests that have received an inspection prior to October 1st, 2023, will continue to be assessed under the previous process. Health Canada will communicate the next steps to licence holders who have an Authorized Activities change request in-process that will not receive an inspection.

The guidance document Overview: Preventive control plan for cannabis extracts and edible cannabis, will help guide cannabis processing licence holders who conduct activities related to cannabis extracts or edible cannabis to develop, implement and maintain their preventive control plan.

Contact the cannabis licensing inbox at licensing-cannabis-licences@hc-sc.gc.ca for any questions.