Health Canada has announced changes to the cannabis licensing regime. These changes come ahead of the release of the cannabis edibles, extracts, and topicals amendments to the Cannabis Regulations expected to be released in the Canada Gazette Part II prior to October 2019.
Effective May 8, 2019 there are changes for both new and existing applicants for licenses to cultivate, process or sell cannabis for medical purposes:
New applicants for licenses will be required to have a fully built site at the time of their application in addition to satisfying the previously established application criteria.
Existing applicants will undergo a high-level review in the order in which they were received, and applications that pass this review will receive a status update letter indicating that Health Canada has no concerns with the existing application.
Amendments to Cannabis Licensing Application Guides
The new application process requirements can be seen in the updated Cannabis Licensing Application Guide.
Specifically, there is now a requirement in the Cannabis Licensing Application Guide to "submit a site evidence package with visual evidence to demonstrate the completion and functionality of their facility" within ten business days of the Cannabis Tracking and Licensing System ("CTLS") application in order for the application to be considered.
Further, "the application will only be processed once both the document portion of the application is submitted within the CTLS and the site evidence package is submitted and received by Health Canada".
Contents of site evidence packages
The site evidence package Health Canada requires is distinct for micro and standard license applicants as well as medical sales applicants and must meet the submission requirements in section 7.1.1 of the Cannabis Licensing Application Guide:
|Guided video tour of the entire site (including both indoor and outdoor areas) highlighting the entire site perimeter and all storage areas.||Guided video tour of the entire site (including both indoor and outdoor areas), highlighting all security features of the site perimeter, operations areas (including all grow areas) and storage areas. All devices must correspond to their location as indicated on the site plan (including all floor plans).||Guided video tour of the entire site (including both indoor and outdoor areas) including all operations areas (including grow areas) and storage areas.|
|Photographic overview of each side of the defined site perimeter.||Photographic overview of each side of the defined site perimeter.||Close-up images of the surfaces (including walls, floors, ceilings and joints) of all operations areas (including grow areas) and storage areas demonstrating they meet the requirements of section 84 of the Cannabis Regulations.|
|Visual footage showing entire physical barrier for the site and all storage areas.||Visual recording device footage that includes the front, back and sides of the defined site perimeter (e.g. east, west, south, and north walls). Complete coverage may be best demonstrated by displaying multiple visual recording device feeds that capture an individual walking around the perimeter.||A video of an individual entering and moving through different areas of the facility demonstrating the intended production process flow through the facility.|
|Footage from all visual recording devices in each operations area (including the entry and exit points of the grow areas) and all storage areas.|
Video would be expected to have sufficient resolution to clearly visualize the area without pixilation, capture the entirety of the areas identified with no blind spots or obstructions, and demonstrate the recording devices ability to capture the information in both low light or night conditions.
In addition to the new requirements with respect to the site evidence package, Health Canada has supplemented previous guidance on the regulatory requirements to be met surrounding Good Production Practices and physical security measures by issuing each item as a standalone guide.
Health Canada states that these changes come in response to feedback from applicants about wait times for applications. Health Canada stated that more than 70% of applicants that passed Health Canada's paper-based review over the past three years were not ready to begin operations, and did not submit evidence to demonstrate that they had a fully built and compliant facility.
Health Canada is also working to establish service standards for the review of applications to improve wait times and predictability for applicants.
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