Health Canada Licence Regulation Updates – May 14, 2019
For New Applicants
- Health Canada will no longer process applications made through CTLS without a fully built facility and a site evidence package that meets the new requirements. This site evidence package must be submitted within 10 business days of submission of the application in CTLS.
- The Confirmation of Readiness (COR) notifications from Health Canada which were previously provided to applicants will no longer trigger the submission of a site evidence package. The expectation of new applicants is to confirm site readiness through the site evidence package either at submission or when prompted by Health Canada through the new review process.
For Existing Applicants
- Health Canada has implemented a “preliminary/high level review” of applications following the screening and intake phase which includes a review and confirmation of site appropriateness, verification of security clearances for key personnel, and local authority notifications as examples.
- Health Canada will review your application between May 8 and June 30, 2019. Applicants who have successfully passed this review will be sent a status letter indicating that there are no “critical concerns” with the proposed application. Health Canada has stated the status letter is not to be viewed as an approval, but rather an indication to submit an evidence package for review.
- The Applicants must complete a site build out and submit an evidence package. Health Canada will conduct a detailed review from applicants in queue, once your file is assigned to an Officer, a 60-day (approximately) service standard will apply.
- Security Clearances were previously processed once the application was in active review. Moving forward, Health Canada will process security clearances only for those applicants who meet the new submission requirements, thereby shortening the wait time.
- Applicants should spend considerable time vetting and confirming the suitability of candidates for their license and in context of these licensing application changes.
It is important to note that the changes in the licensing process have not removed any of the requirements or steps applicants needed to take in completing an application. Instead, the changes have shifted the order in which these activities take place and require some clarifying and additional information in the application and evidence package themselves.
- Existing ACMPR Applications who have yet to transition their application in CTLS must complete this step as soon as possible.
- For those existing applications whom received a COR and already transitioned in CTLS, are not impacted by the recent announcement and should proceed as instructed by Health Canada.
- For applicants who are actively building their facilities, the changes are a positive change because processing times are expected to decrease, and Health Canada will prioritize your application.
New Guidance Documents
On the same day of their announcement, Health Canada shared updated Guidance Documents for the following areas which can be located on the Health Canada website:
- Cannabis Licensing Application Guide
- Good Production Practices (GPP)
- Physical Security Measures
These changes provide clarity in the licensing process. We encourage applicants to contact CCI for more information on how best to move forward with their application. CCI has extensive experience successfully assisting applicants through the cannabis licensing process and are ready to assist you with your application.