On May 8, Health Canada published a statement introducing changes being made to cannabis licensing. Health Canada is implementing these adjustments as a result of many factors including feedback from applicants regarding the time it takes to get licensed, the number of applicants already in queue for a cannabis licence and to better allocate resources thereby reducing long wait times. Health Canada has implemented the following changes, effective immediately, based on stages of the application process:
New Applicants – Health Canada will require new applicants for licences to cultivate cannabis, process cannabis, or sell cannabis for medical purposes to have a fully built site that meets all the requirements of the Cannabis Regulations at the time of their application, as well as satisfying all other application criteria. Applicants will also be required to submit their site evidence package upon submission in order for Health Canada to begin application screening.
Existing Applicants (who have NOT received a Confirmation of Readiness Letter) – Health Canada will complete a high-level review of applications currently in the queue. The high-level review will consider items such as the classes of licences being applied for, site appropriateness, if security clearance applications for all necessary individuals have been submitted, and if notices to local authorities have been provided. If the application passes this review, the Department will provide a status update letter to the applicant, indicating that it has no concerns with what is proposed in the application. Once the applicant has a completed site that meets the regulatory requirements and they have submitted a site evidence package, the Department will review the application in detail, in priority based on the original application date.
Existing Applicants (who have received a Confirmation of Readiness Letter) – Health Canada has not implemented any changes for this group and there will be no change to the application process. These applicants should migrate their application to CTLS as soon as possible (if not already migrated) and submit a site evidence package as already requested.
Furthermore, the Department is also working to establish service standards for the review of applications, which will increase predictability for applicants. For processing, cultivation and sale for medical purposes licence applications, there is a 30-day service standard for completion of screening of the application by Health Canada. The application screening cannot take place until Health Canada receives the site evidence package and so the 30-day service standard will commence upon receipt of the complete application submission.
To support applicants, Health Canada has made available additional guidance on the licence application process and on the regulatory requirements regarding Good Production Practices and physical security measures. It should be noted that there are no changes to the regulatory requirements (security clearance process for key personnel and corporate directors, pre-licence inspection of site, etc.).
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