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Cannabis Research License

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Under the Cannabis Act and Regulations, companies seeking to perform research on cannabis with the intention of developing new products and technologies are required to hold a Research license. 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.

Research License Holder

A Research license holder is authorized to conduct experiments and testing on every form and derivative of cannabis, including live plants, fresh and dried plant material, seeds, oil, wax, and manufactured items such as edibles and topicals.

The Research license encompasses all kinds of cannabis-related study, from advancements toward better growing and processing techniques, to improving upon cannabis-infused products, and more.

License holders are permitted plenty of material to experiment with as they are allowed to grow and possess cannabis, and they also have the right to distribute and sell it within a limited group of individuals.

License Overview

Who Is A Cannabis Research License For?

A Research license is perfect for businesses, including pharmaceutical companies, experimental laboratories, and cannabis producers, large enough to have their own R&D departments, that are looking to conduct in vivo and in vitro studies, clinical trials, plant genetics studies, cannabis product development, or cannabis educational programs. It is important to note that organizations that already hold another license under the Cannabis Act, such as a cultivation or processing license, may already be authorized to conduct research and development activities under the terms of that license.

What Can You Do With A Cannabis Research License?

The Research license

Encompasses all kinds of cannabis-related study, from advancements toward better growing and processing techniques, to improving upon cannabis-infused products, and more. In addition, a Research license authorizes the holder to legally administer cannabis to research subjects, plus distribute it in a limited manner to either the Minister, or other companies with an R&D, Analytical Testing, or Cannabis Drug License.

A Research & Development License

Permits companies to possess and produce cannabis for study, as well as transport it between sites that are specified on the license. As mentioned above, Research license holders are authorized to conduct experiments and testing on every form and derivative of cannabis, including live plants, fresh and dried plant material, seeds, oil, wax, and manufactured items such as edibles and topicals.

There are three models of research licenses that are currently available:

  1. One project, one site: One research license covering one research project, generally with a single research protocol and activities taking place at only one site.
  2. One project, multiple sites: One research license covering one research project, but with research activities taking place at multiple sites (e.g., a clinical trial at numerous hospitals).
  3. One institution, one site: One research license 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).

What Isn’t Covered Under A Cannabis Research License?

Those who hold a Research License are allowed to grow, possess, sell and distribute cannabis – but only within the guidelines that the license terms provide for (listed above). A Research License does not authorize the holder to give the general public any kind of access to the cannabis, or cannabis materials, that they grow and/or work with.

Cannabis Research License Requirements

  • The holder of a Research License must retain the services of one individual as the Responsible Person, who has the authority to bind the holder. The Responsible Person will be accountable for the license holder’s activities and should have an adequate understanding of how the Cannabis Act and Regulations apply to the license holder.
  • The Research license holder 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). The 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.). It will need to be mentioned if human subjects are involved with the research, such as for clinical trials or palatability studies.
  • The license holder’s facility must have restrictive measures in place around their operational areas in order to safeguard against unauthorized access. It should be possible to demonstrate how the area’s construction, as well as any access controls on the exit and entry points, are able to achieve this goal. Access to all operational areas must be restricted to certain personnel only.

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Cannabis License Experts is a compliance solutions provider consisting of in-house professionals with extensive Cannabis, Pharma, Food, Medical Device and Drug regulatory
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