Did you know you can apply for a licence under the Cannabis Act and Cannabis Regulations to conduct activities in relation to research involving cannabis? These research activities can include, but are not limited to, in vivo and in vitro studies, clinical trials, plant genetics, cannabis product development, and educational programs. If you want to learn more about how a cannabis research licence works and what’s required to apply, keep on reading.
Before getting started, it’s important to mention that if you or your organization holds another licence under the Cannabis Act, such as a cultivation or processing licence, you may already be authorized to conduct research and development activities under the terms of that licence.
If you don’t already hold a licence under the Cannabis Act, there are three models of research licences that are currently available:
- One project, one site: One research licence covering one research project, generally with a single research protocol and activities taking place at only one site.
- One project, multiple sites: One research licence covering one research project, but with research activities taking place at multiple sites (e.g., a clinical trial at numerous hospitals).
- One institution, one site: One research licence covering multiple research projects taking place at one institution (e.g., numerous researchers or projects at a single university campus or research hospital; or a large research group performing multiple projects, such as a contract research organization).
In order for your application to be considered, you should already have a facility or building unit that is dedicated to your research project and is already built out. As part of the application, you will have to show some information regarding your site, including a site plan, floor plan and description of the physical security that is in place to prevent unauthorized access to the cannabis storage and operations areas.
Another important part of the application for a cannabis research licence is the Research Protocol. Your team should have a well written Research Protocol summarizing the proposed research to be conducted and the amount and type of cannabis required for the research (e.g., gram, kilogram, litre or number of plants or seeds, broken down by site, if applicable). Your Research Proposal should also detail the tools and equipment to be used to perform the research with cannabis (e.g., analytical techniques, specify any in vivo or in vitro models to be used, etc.). You will also need to mention if human subjects are involved with this research, such as for clinical trials or palatability studies. Providing a clear, detailed and thorough Research Proposal will facilitate the timely review of your research licence application.
Once an application has been submitted, Health Canada states they follow a non-binding 42 business day turn-around service standard for single project applications, and up to 180 business days for multiple project or institution-wide applications. Keep in mind, these time estimates are dependent on the volume of other applications awaiting review and approval. So, if there is a backlog of applications in queue for review, you can be waiting anywhere from 9 to 12 months to receive your licence.
If any further information is required during the application process, Health Canada will send a request for more information (RMI). The applicant must respond to the RMI by email within the timeframe requested, most often 10 business days. Responses should be comprehensive and comment on each of the elements noted in the RMI. Once Health Canada has all of the information they require and they deem your application and information compliant, a research licence will be issued and you can get started on conducting your cannabis studies!
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