Cannabis Drug Licence
In Canada, the Cannabis Regulations has introduced a new type of facility licence, called a Cannabis Drug Licence, which authorizes a company to manufacture and sell a drug (as defined in the Food and Drugs Act) that contains cannabis.
The prerequisite for applying for a Cannabis Drug Licence is that the company must already be a holder of a Drug Establishment Licence (DEL) under Section C.01A.008 of the Food and Drug Regulations. (This type of facility licence is also required for manufacturing pharmaceutical products). Achieving both the DEL and Cannabis Drug Licence would permit a facility the following activities with respect to cannabis pharmaceuticals; possession, production/manufacturing, distribution and sale. Note that individual cannabis drug products would also be required to hold a Drug Identification Number (DIN) per product, the requirements of which are substantial with regards to clinical research in humans.
Note that the application requirements for a Cannabis Drug Licence are not yet formalized or published, however it is expected that they will mirror the requirements of a narcotic Dealer’s Licence under the Narcotic Control Regulations. CCI staff have extensive experience in the pharmaceutical industry, with regards to Drug Establishment Licences as well as Drug Identification Numbers. Our staff will develop a solid foundation for assisting the applicant to achieve both a DEL and Cannabis Drug Licence under the new regulations.
Note that a holder of a Cannabis Drug Licence must also meet the physical security requirements for their site as per Sections 63 to 72 of the Cannabis Regulations, or if they intend 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.
Cannabis Compliance Inc is the global leader in professional cannabis expertise with extensive pharmaceutical experience among our team. Contact us today to start the conversation around a Cannabis Drug Licence.