We get a lot of inquiries about the process involved in becoming a licensed producer of cannabis under the Access to Cannabis for Medical Purposes Regulations. Some of these inquiries are from business people who have the capital and the desire to go through the process. Other times the inquiries come from professionals who have no interest in actually applying, or from people who are just plain curious.
We thought it might be time to do a post setting out the application process at a very high level. This post will not talk about what is required in the application itself, nor will it talk about the variety of information that the government may seek during the application process notwithstanding that the information it is requesting is not required as part of the application itself. We also don’t discuss here how long the process and the various stages takes (hint: it varies and “a while”). Instead, the purpose of this post is simply to identify the stages of the process and provide a simple summary of what that stage entails.
Stage 1: Preliminary Screening
The first stage involves a preliminary review from Health Canada to ensure that the application is complete. Many people are surprised to hear that as of March 31, 2017, 841 of the 1630 applications that have been received by Health Canada were returned as being incomplete.
If the application is complete, it is given an application number and proceeds to the second stage.
Stage 2: Enhanced Screening
After receiving an application number, the application is reviewed again in more detail. At this stage Health Canada will review the location of the proposed cultivation site, the likely risks to public health, safety and security, the proposed security measures and the credentials of the proposed quality assurance person.
Health Canada also reviews the application at this stage for the purpose of ensuring that the level of detail contained in the application is sufficient to allow the government to assess the requirements of the regulations.
Health Canada may also request additional information from the applicant that is relevant to the application at this stage.
Stage 3: Security Clearance
After the application has passed two stages of screening, the security clearance forms that are required for designated personnel will be sent for processing.
Stage 4: Review
At this stage the application is reviewed in great detail to validate the information that has been provided and to obtain clarity and further information as required. At this stage the physical security plans that are required as part of the application are reviewed and assessed in detail.
Stage 5: Pre-license Inspection
At this stage the cultivation facility is inspected by Health Canada. The inspection includes, but is not necessarily limited to, a review of security measures, good production practices, packaging, labelling and shipping, registration and record keeping.
Stage 6: Licensing
If the pre-license inspection is passed, Health Canada completes its final assessment of the application and sets a limit on the licensed activities as well as the maximum limit on the total amount of cannabis that is authorized for production.
Sound fairly straight forward? It’s not. Applicants can be sent back to a previously cleared stage if new information affecting the application is received by the government. Additionally, changes to the application, including changes to personnel or modifications to the plans for the physical facilities may, and in some cases will, result in the application being returned to a previously cleared stage.
Anyone who has been through the process will tell you that is it long, arduous and expensive. We’re talking over a year and millions of dollars. Not for the faint of heart.