Research & Development Licence
While many producers and applicants are keen to have an R&D department, few seem to understand what this entails.
Companies should ask them what they want to do R&D for – i.e., what is the desired end result? To create a unique finished product and the manufacturing technology required? Or to create a unique nutrient formula and test this on live cannabis plants? There are many reasons why a company may want to achieve an R&D Licence, and at the end of the day if they want to be in possession of cannabis material or live plants (for whatever reason), the R&D Licence is the vehicle to achieve this.
Prior to the Cannabis Regulations being published recently, a company desiring to do R&D with cannabis would have applied for a Dealer’s Licence under the Narcotic Control Regulations. This is because the possession of cannabis for any purpose (and in a format) outside of the previous regulations was within the context of it being a narcotic. Today, cannabis is no longer scheduled as a narcotic, as the empowering legislation is now under the Cannabis Act rather than the Controlled Drugs and Substances Act. A Dealer’s Licence (DL/LD) was therefore required for both analytical testing laboratories and R&D facilities. Companies who are currently in possession of a DL for cannabis purposes are being transitioned either the R&D Licence and/or Analytical Testing Licence. In some cases, the DL may also be transitioned into a Micro (or Standard) Processor Licence if the original DL was processing for biotechnology purposes rather than for R&D purposes.
Note that a Processor (Micro or Standard) Licence does authorize a facility to be in possession of cannabis and conduct R&D but only with regards to the permitted forms of cannabis (e.g., live plants, fresh and dried plant material, seeds, oil), which is narrow in scope. An R&D Licence, on the other hand, allows for the R&D around any form or derivative of cannabis, including finished products such as beverages and edibles. Note that an R&D Licence does allow a facility to sell plants and seeds if desired. In comparison to a Processor Licence (Standard or Micro), overall the R&D Licence has reduced requirements with regards to mandatory personnel, security clearances, physical security and Good Production Practices.
Within the context of an R&D Licence, a company would likely be setting up an experimental laboratory for the purpose of research and development. This requires a considerable amount of forethought and planning, not to mention procedures, validation work and equipment sourcing. Cannabis Compliance has expertise from the pharmaceutical and other sectors related to R&D to design a laboratory facility, achieve the R&D Licence, sourcing/qualifying/installing equipment, software validation, SOP’s, security system design/implementation and general research support.
Contact us today to start the conversation around achieving a Research & Development Licence within the Cannabis Regulations.