Can cannabis businesses benefit from a Cannabis Research Licence?
Health Canada offers a variety of cannabis licences for different purposes, this includes a cannabis research licence option. With a cannabis research licence, institutions can conduct scientific studies of cannabis. It has other purposes too though! You can also obtain a cannabis research licence for conducting clinical trials, plant genetic studies, cannabis product development, and educational programs.
Cannabis Research Licencing for Product Development
Product development takes some trial and error. Whether that product is dried cannabis flower, concentrates or edibles, it will take some trial and error before your formulations and processes are perfected. If you are starting a cannabis cultivation business in Canada, you may want to consider getting a cannabis research licence.
As you may know, Health Canada requires growers to have their sites built and ready to operate prior to applying for their cultivation licence. They also require growers to have a robust quality management system (QMS) with SOPs. What may be less clear to growers is that validations may also be required.
Validation and Process Development
A validation, such as a process validation, is a study that demonstrates regulatory compliance. Here is an example: You have an SOP for your packaging process where dried cannabis buds are weighed then placed in a mylar bag. The mylar bag is then sealed and labelled with the required information. The regulations require your packaging process to prevent product contamination, ensure label accuracy, and ensure proper weights are tracked and recorded.
A process validation of your packaging SOP could involve microbial sampling of the materials, surfaces, equipment, and personnel used during the packaging process. You might also send the packaged product for shelf-life testing, and do audits of the process to ensure that there are checks in place that ensure label accuracy and proper tracking and recording of information. Once validated, the SOP and the actual process cannot be changed or altered in any way without conducting another validation. If directions aren’t followed that means a “deviation” has occurred and your QA team will need to evaluate the risk of the deviation and create a corrective or preventative action plan (CAPA).
Along with validating production and manufacturing processes, you may also need to validate things like your sanitation program. This is done through environmental monitoring and usually needs the assistance of a contract laboratory. In all cases, you can use a cannabis research licence to operate in order to perform these validations since they are part of product development.
Cannabis Research Licencing for Genetics
Another wise use of a cannabis research licence is to establish and evaluate cannabis genetics that you are interested in propagating. Establishing your genetics through controlled research helps you determine the proper conditions you need in your facility and also helps you determine which varieties of cannabis will be the best for you. Using GrowerIQ Seed-to-Sale Software is especially helpful for activities like this since it offers the ability to continuously monitor your cultivation spaces and track crop metrics. You can also track test results and run reports to compare crops.
Having these insights before you become fully operational will set you up for success. Health Canada may also want to see some evidence that your crops reliably retain their genetic fidelity. Conducting studies with a cannabis research licence will allow you to gather that data. Here are just a few examples of cannabis genetic research that may interest you:
- Determining how many cuttings can be taken and how long mother plants can be used
- Determining ideal temperature, humidity, and CO2 for your specific cultivars
- Screening clones
- Evaluating planting density and yields for specific varieties
- Evaluating if plants reliably produce the same amounts and proportions of cannabinoids
- Evaluating plant terpene profiles and their reliability
- Studying which nutrient formulas are best for specific cannabis varieties
Another use of the cannabis research licence for plant genetics is to conduct breeding studies and develop new cannabis varieties. With the rise in copywriting cannabis strains, you may be interested in creating proprietary cannabis genetics. With the research licence, you are able to work on developing and testing genetics prior to obtaining a cannabis nursery licence and selling clones or seeds.
Cannabis Research Licence Models
Health Canada offers three different models for cannabis research licences:
One project, one site: One single research protocol/project at a single site, or multiple research projects under a single principal investigator in a single area of research
One project, multiple sites: For projects that have multiple sites such as a clinical trial that is taking place at multiple hospitals
One institution, one site: Multiple research projects that are taking place at a single institution such as a single university or single research group
How to Get a Cannabis Research Licence in Canada
Applying for a cannabis research licence is similar to the process for applying for cultivation licences.
Step 1: Contact Health Canada and confirm that you qualify for a cannabis research licence and need one for your activities. Also, determine which cannabis research licence model fits your needs.
Step 2: Create an account in the Cannabis Tracking and Licensing System (CTLS) and complete your profiles.
Step 3: Develop your research licence application. Your application needs to cover six main sections. These are:
- Licence ownership
- Mailing address
- Site details including research activities and research protocols
- Site personnel
- Physical security
- Record keeping
Step 4: Submit your application for review.
Can You Sell Research Cannabis?
While the specific details are not entirely clear, there is the possibility to sell cannabis cultivated for research within limits. Depending on your research protocol and partnerships, you may be able to sell research cannabis plants or seeds to cultivators, other researchers, cannabis drug licence holders, or the government. However, you may also be required to destroy your cannabis if your research protocols do not consider such arrangements.
When you contact Health Canada to confirm your need for a research licence, you’ll want to inquire about the allowances and restrictions for selling research cannabis and make sure your research protocols optimize this. Health Canada does not expect all research licencees to have grant funding, so consider ways to recover your research costs without compromising the integrity of the research.
According to Canadian cannabis laws, cannabis research licences allow for the following authorized activities for research purposes:
- Cannabis possession
- Cannabis production
- Cannabis transport and delivery
- Sell cannabis plants or seed to cultivation licence holders, research licence holders, a holder of a cannabis drug licence, the Minister, or a person to which an exemption has been granted under section 140 of the Act in relation to the cannabis or class of cannabis that is sold or distributed
Cannabis Research Licence Cost
Cannabis research licences require a fully built site, just like cultivation licences. However, cannabis licencee fees are only applied to licences for standard cultivation, standard processing, micro cultivation, micro processing, sale for medical purposes, and nursery. According to Health Canada,
Fees do not apply withrespect to other licence classes under the Cannabis Act. For clarity, fees do not apply with respect to industrial hemp, research, analytical testing, or cannabis drug licences.
Final Thoughts on Cannabis Research Licences in Canada
Cannabis research licences aren’t for everyone. Some businesses just want to get up and running as fast as possible. For those who want to spend more time developing their business processes and products, it is a great option to consider since you will save on licensing costs. They also give you the opportunity to build a relationship with regulators. The processing time for research licences is 42 business days for a single project or 180 business days for multiple project or institution-wide applications, so you may be able to get up and running faster than with a regular cannabis licence. While the research licence won’t allow you the same activities as standard licences, it will allow you to start working out the kinks and developing a strong business with sound processes and products. It will also help you be more prepared when you do apply for standard licences.
Find Out More
Consult with GrowerIQ to find out if a cannabis research licence is right for you. Click the button below to get in touch with one of our experts, and find out how GrowerIQ can help your cannabis operations reach its maximum potential.
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