We’re often asked whether or not to submit an application for a research licence or a licence to produce medical cannabis under the Marihuana for Medical Purposes Regulations (MMPR). Many people are under the impression that a research licence is faster to obtain, and that it is legal to sell cannabis to registered clients using this licence. Both assumptions are incorrect.
Many people are under the impression that a research licence is faster to obtain, and that it is legal to sell cannabis to registered clients using this licence. Both assumptions are incorrect.
NHP Consulting has experience submitting both types of licences, and the differences are night and day. For both types of applications the wait times are over a year, around the same timeframe for either. Also, any cannabis cultivated and harvested under a research licence can only be used for research and can’t be sold to a registered client under the MMPR.
Here are some facts about the Acts and Regulations surrounding a cannabis research licence. Previously, applicants had to submit two applications if they wanted to cultivate and extract certain phytochemicals (namely cannabidiol) for research and / or development. This is a requirement under the Narcotic Control Regulations (NCR) since cannabis is defined as a narcotic. This is no longer the case, however. An amendment to the NCR now allows applicants to submit one application for both cultivation and extraction, thus eliminating the need for a second set of physical security measures and personnel working hours. Nice to see Health Canada has streamlined the process.
If you are interested in a cannabis research licence, there is some fundamental requirements you should be aware of. First, you will need a physical address with the owner’s consent. This does not mean the building has to be operation-ready or even built! The location should be as isolated as possible from houses and schools. Rule of thumb is 500m, and even while we have been successful with closer proximities, it is still a healthy rule of thumb to follow.
You’ll also have to have a game plan. For instance, if you’re interested in isolating cannabidiol (CBD) for a human clinical trial, you may have to work with a third party for the final formulation that will include CBD and other non-medicinal ingredients, and possibly a third party packaging company. You will also require a Qualified Person In Charge (QPIC) of the research you’re proposing to underatke. Health Canada will want to see their credentials. If this person is isolating CBD, do they have research experience with botanicals, analytical skills and experience with supercritical CO2 extraction? Do they have a degree in pharmacy, medicine, pharmacology or chemistry?
In addition to having the right people involved, a security plan is essential and is comparable to the requirements of the MMPR (except for the requirement for a minimum level 7 vault). The security plan will include a risk assessment of the area, secure storage, access restriction, and surveillance using cameras and motion detectors.
It will also be critical to prove to Health Canada that you have strict control over the inventory. The submission should include the flow of product from receiving, to cultivation and harvest, all the way to the finished product. NHP Consulting has experienced consultants from the pharmaceutical and narcotic industries that can help navigate the inventory control requirements. Health Canada will look for this type of experience and how it is represented in the application by using sample receiving logs, batch production records, certificate of destruction (among other logs).
Since cannabis is a lucrative commodity on the black market, Health Canada is also interesting in the source of funding. An additional requirement is a criminal record check for the responsible persons and all others that are a part of the research project. Any individual that has a prior drug or criminal offence would result in the application being rejected.
Feel free to give us a call to discuss this article further or if you have unique situations in where you would like to run both a research facility with a commercial licence to produce cannabis for registered clients and a research facility that is connected with a human clinical trial. You may contact us here.