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CBD and THC Product License

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One of the most significant aspects of the Cannabis Act and Regulations is the introduction of a Cannabis Drug License, which will help pave the way for companies looking to develop prescription cannabis-based medications.

This license gives companies the ability to produce and sell prescription drugs containing cannabis. Its inclusion in the Act could turn out to be especially beneficial for consumers, as while medical cannabis isn’t currently covered by insurance, the Act requires that cannabis medicines be given drug-identification numbers, which will provide them with coverage. The first step for companies with the goal of making advancements in cannabis-based drugs is obtaining this license. One important stipulation is that applicants must currently hold a Drug Establishment License (DEL) under Section C.01A.008 of the Food and Drug Regulations, which is required for the manufacturing of pharmaceuticals in general.

License Overview

Who Is A Cannabis Drug License For?

This license is for any individual or company interested in the study and development of cannabis-based pharmaceuticals. It could be an ideal fit for medical research facilities, experimental labs, supplement and pharmaceutical companies, as well as Research & Development and Analytical Testing license holders who work with cannabis.

What Can You Do With A Cannabis Drug License?

It permits license holders who also carry a Drug Establishment License the right to possess, produce/manufacture, distribute and sell drugs containing cannabis. Such drugs can be sold to pharmacists, hospital employees, practitioners (such a doctors, dentists, veterinarians and laboratory technicians), as well as Research & Development and Analytical Testing license holders, among other parties. Cannabis-based drugs are authorized to be administered to both people and animals.

What Isn’t Covered Under A Cannabis Drug License?

Providing the general public with access to any form of cannabis or cannabis-based drugs is not permitted. The same is true of growing and cultivating cannabis.

Cannabis Drug License Requirements

  1. It is required that the license holder have a security clearance.
  2. The license holder needs to have an individual in their employment who can act as their “responsible person”. This person is considered accountable for the license holder’s actions and should have an adequate understanding of how the Cannabis Act and Regulations apply to the holder. Should they have to, this person also has the authority to bind the license holder. They are required to have a security clearance, and one qualified alternate may be designated.
  3. To qualify, one must currently hold a Drug Establishment License (DEL).
  4. The licensed facility must have any on-site storage and operations areas surrounded by a physical barrier in order to safeguard against unauthorized access. It should be possible to demonstrate how the barrier’s construction, as well as the required access controls on the exit and entry points, are able to achieve this goal.
  5. Access controls restricted to authorized personnel only are required around storage and operations areas, and a record must be made of everyone who comes and goes from the storage areas.
  6. Each storage area must be located in an area that satisfies the security measures outlined in the Regulations.
  7. The site perimeter, operations areas, and storage areas are required to be monitored by visual recording devices at all times to detect and record any unauthorized attempts, successful or unsuccessful, to access the site. Entry and exit points on grow areas must be visually monitored as well.
  8. The site perimeter, operations areas, and storage areas must have an intrusion detection system operating 24/7 to discover any unauthorized attempts to access the site or tamper with the system. It must also be possible to detect unauthorized movement within operations and storage areas.
  9. The intrusion detection system is required to be monitored at all times, and the license holder is responsible for determining what measures are appropriate in response to any incidents. In cases where an incident occurs, the holder must retain a document that contains the date and time of the occurrence, how it was responded to, and the date and time of when that response took place.
  10. If the license holder intends on securely storing cannabis in accordance with the Directive on Physical Security Requirements for Controlled Drugs and Substances and Drugs Containing Cannabis, they are exempt from the requirements of the Cannabis Regulations listed above.
  11. Individual cannabis products will be required to have a Drug Identification Number.

*Full license requirements have not yet been published, but they are expected to resemble those of a Dealer’s License under the Narcotic Control Regulations.

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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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