One of our posts talked about the various missteps that a Licensed Provider applicant should avoid in order tobe able to sell medical marijuana within the MMPR (Marijuana for Medical Purposes Regulations) regime in Canada.
The demand for medical marijuana in Canada is immense, and there has been a 13% month over month increase in enrollment of new patients in the MMPR program between May and Aug 2014.
Fig 1 shows the different projections of patient population by Dec 2015 from a base of around 9500 patients in Aug 2014 while Fig 2 shows the amount of medical marijuana needed to satisfy that demand
However, Health Canada has shown no particular alacrity in approving licenses for LPs. About 50% of the time is taken up during the documentation and approval stage in government offices even before anything moves on the ground. And many applicants are waiting for up to 6-9 months for inspections from Health Canada.
A number of applicants have spent months researching, raising funds and hiring even before formally starting the official application process.
When you apply to be an LP, you are not supposed to start building immediately. If your application is in order and Health Canada is confident of your capabilities they will issue you a Letter to Build, and then you can commence building on the ground.
Furthermore, chances are that if you have not prepared properly the department will send you aDeficiency Letter. This letter says that your application is incomplete, and you have to restart the process. It will further delay the progress of your application by pushing you to the back of the line.
Addressing deficiencies in LP applications
When Health Canada considers an application, one of their primary motives is to ensure that the final product is safe and medical grade while the manufacturing process follows all related regulations. Some areas where the application needs extra clarity are:-
1.Warehouse or Greenhouse- LPs are using both warehouses and greenhouses to grow marijuana plants. While greenhouses are more suitable, as the plants can be exposed to natural light, maintaining a consistent internal temperature is expensive, especially if the square footage is high. The application needs to have a definite plan for addressing these issues.
2. Environmental controls- Several variables, such as varying types of light source, the air pressure,composition of nutrient solution,etc.play a significant role in the quality of the final product. Most hi-tech facilities use computerized systems to manage these inputs to minimize human interference. The facility cannot pass final tests if these environmental controls are not working flawlessly.
3.Security of the site- Health Canada can fail you for a multitude of reasons related to security. It’s just not enough to secure the perimeter and put up a bunch of cameras. Your application should have detailed risk and threat assessments, specifically with respect to general crime levels in your area. You should not think of marijuana security for security purposes only, but rather also consider the reality that by regulating access you can also minimize or prevent crop spoilage.
4. Testing- Health Canada takes gaps in production practices very seriously. A single mistake in the long “seed to weed” chain can result in dodgy product that would necessitate recall and even suspension of license.A testing protocol has to be detailed in the application as marijuana cannot be shipped out to customers without multiple testing rounds, including by the LP/third party labs and Health Canada.
5. Storage- No amount of testing will work if packaging and storage are done carelessly. Since dried medical marijuana is an organic product,it retains moisture from the environment and can harbor impurities like spores and mildew. The application has to detail the packaging, storage and shipping protocols so that the chance of spoilage is minimal.Sellers should also educate customers on how to handle the product in order to avoid recalls.
6. Criminal checks- When it comes to the RCMP security clearance, your application has to mention your complete details of the senior people as laid out in the MMPR rules. Estimates of how long the security checks take vary- some clearances come fast if the individual being checked out has not moved around much. However, if the person has lived throughout the country or abroad, or has worked under the old MMAR regime, clearances could take awhile as the RCMP might have to contact Interpol, the DEA or the FBI.
7. Location- Because medical marijuana facilities take up so much space, setting them up in a proper location is crucial for Health Canada to give you the nod. For instance, if you have plans to build the facility in a residential area, Health Canada will likely say no. Applicants will also have to work with the local community to deal with NIMBY (Not in My Backyard), given that some communities will havemisgivings over industrial marijuana farming. They will also have to comply with local zoning regulations and fire codes.
8. Qualified personnel- Health Canada will not give you the green light to start operations until you have a team of qualified personnel already in place. These people include master growers, a Quality Assurance Person and the SPIC (Senior Person in Charge)/ RPIC (Responsible Person in Charge). Among other things, they are responsible for drafting Standard Operating Procedures,implementing Good Production Practices, running self- audits and preparing for Health Canadaaudits and performing record keeping and documentation duties.
At Health Canada, out of 2000+ applications received, about 20 are either selling or in the process of marketing medical marijuana Security. Additionally, Health Canada has this habit of asking very detailed questions and trying to poke holes in your application.
Prepare for success, and make your documentation as extensive as possible. Leverage experts to save you headaches and cost.