In July 2015, Health Canada released a statement on the Smith case, the result being they are now allowing licensed producers under the MMPR to manufacture cannabis oil for sale to Canadians. This is the first time a so-called “derivative” has been permitted for sale in Canada, and I wanted to provide some insight into how this works.
The changes were effective immediately, however licensed producers who had a licence to cultivate have to achieve a “supplemental licence” to start producing and selling cannabis oil to registered clients (see Section 56 Class Exemption for LP’s).
There are restrictions being imposed, notably the THC concentration must be no greater than 3% w/v (30 mg THC per 1mL oil). However, there does not seem to be a restriction on the concentration of other biomarkers such as CBD. There are also many extra requirements for labelling and packaging, but they’re unimportant details at this point. Pharmaceutical in nature.
What is particularly exciting is the allowance of capsules such as gelatin capsules containing cannabis oil. Similar to fish oil capsules. Now, the cannabis oil capsules cannot contain any flavour or scent, but there doesn’t seem to be a restriction on excipients at this time. For example, if the oil is quite thick, a diluent could be used to make filling easier. However, we have yet to understand excipient use.
All of this means that supercritical extraction techniques (and machinery) can now be legally imported into Canada and used by licensed producers to manufacture cannabis oil. Why this is exciting for the industry, is it is a positive step forward allowing the free sale of medical marijuana in dosage forms that are better suited to the health of Canadians. We wouldn’t give our children cigarettes; we wouldn’t give them a joint to smoke. Gel caps are a healthier solution that help with dosage compliance.
There are other changes, such as allowing individuals to make their own oils, so long as they don’t use organic solvents. But these are outside our scope of business practice, as our company caters to the commercial scale production of marijuana products.
Becoming a licensed producer (i.e., a legitimate producer) of medical marijuana in Canada is an exciting venture given the Trudeau government’s endorsement of marijuana. In my opinion, the marijuana industry will show two industries develop and emerge – a medical marijuana industry, with point of sale in pharmacies and marijuana dispensaries, and a recreational marijuana industry (with a point of sale unknown at this time). In order to become a licensed producer of marijuana oil, a rigorous application and quality screening process is required, where our company assists. Becoming a commercial producer of marijuana oil is no small venture in 2016, although in later years the capital requirement may shrink as the industry enlarges.