Marijuana grown for medical use is increasingly moving from home or small- time growers to sophisticated corporate greenhouses. They look no different from a typical pharmaceutical plant, with equivalent standards in terms of quality control for the final product.
Authorities have implemented astrict licensing policy by updating the MMPR (Marijuana for Medical Purposes Regulations) regime. Health Canada, the nodal agencyhas given a nod to only22 applications out of 1009 received!
A decently sized facility requires investmenting the ball park of hundreds of thousands of dollars even before a gram of marijuana can be shipped out. Hence, it is critical that applicants who want to be licensed providers do all i’s and cross all t’s.
The Process of Granting Licenses
Health Canada moves fairly slowly when it comes to doling out licenses for medical marijuana production even though reports estimate that they are getting up to 25 applications per week.
Applicants need to submit extensive documentation to the authorities; often these documents total more than a hundred pages.
Documentation has to be very detailed and has to address a number of concerns, centered around
- Physical security of the location
- Production processes
- Quality control
- Record keeping
Once Health Canada receives the application and acknowledges its receipt, it will issue a Ready to Build letter in the event it deems the application to be legitimate. This letter is a green light to start investing in infrastructure.
Once the applicant has built or upgraded the infrastructure as per the instructions laid out in theReady to Build letter, Health Canada will inspect the facility before production begins. They will perform yet another inspection before the first shipments go out.
Issues to look out for
Health Canada has extensive documentation online on how to become a medical marijuana licensed provider.
However, there are plenty of booby traps along the way, and you can easily trip if you are not thorough with your application. Some issues to look out for are:
1) Authorized personnel- Guidelines mandate that there should be a Senior PIC (Person in Charge), assisted by a RPIC (Responsible Person in Charge). The producer will also have to appoint one or more A/RPIC (Alternate Responsible Person in Charge). These people are responsible for the site, and Health Canada needs their complete details, down to work hours. Skip on this provision and the application could be in trouble.
2) Security clearances- All individual applications, directors and officers of corporate applicants and the PIC, RPIC, and A/RPIC need to hold valid security clearances by passing a RCMPcriminal check. Unless all the above-mentioned individuals are in the clear, no license will be awarded.
3) Complete site information- The application requires full details of the site where production is to take place. The site should not be a place of residence and should be indoors. Other entities cannot share the site. Other details about the site and the buildings are also mandatory, including standard operating procedures regarding the sanitation of the facility.
4) Security of the site- Medical marijuana security is a hot button topic and the focus here is ensuring that the entire site, no matter how sprawling,does not have any blind spots enabling unauthorized access. Health Canada expects a detailed description of security measures, includingperimeter security, access control, intrusion detection systems and video surveillance.
5) Production practices – Successful applicants have designed their facilities to resemble pharmaceutical plants. Accordingly, the applicant has to document the exact procedures that they intend to follow during production, right down to the strains of marijuana used, drying method and mode of harvesting.
6) Quality control- Each applicant must have designated Quality Assurance Person (s) on staff per site whose job is to monitor the quality of the end product. Their responsibilities, covered underSection 60.1of the MMPR include
- Environmental surveillance
- Inspecting production and packaging lines
- Preparing and managing quality control documentation
- Performing final tests on the dried product, like microbial testing
7) Record of activities- Medical marijuana facilities not only produce dried marijuana, but also produce seeds and supply marijuana plants to other LPs, andeven conduct tests on the final product. The application must clearly mention all these details, such as the maximum amount of dried marijuana, in kilograms,the producer intends to sell to registered clients.
8) Notice to local bodies- The applicant must inform local government, fire department and police in writing, before applying to become a Licensed Provider. This notice has to inform the local authorities of all the details of the facility, and the application to Health Canada has to include their contact information. If these authorities raise any objections, Health Canada might reject the application.
9) Shipping and delivery records- LPs need to put a fool proof system in place for inventory control, client ordering, client registration and packaging and shipping marijuana to patients. Not paying attention to these can cause leakages from the system and put the kibosh on that application.
10) Recall protocol- Sometimes, despite stringent quality control, producers may have to recall batches of the finished product due to one or two samples developing abnormalities such as mould. In such cases, the LP will have to document a method to recall the product from buyers.
Not rushing through the application protocol and taking the help of qualified professionals can increase your chances of getting to the pole position in the LP race.
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