Cannabis Drug License (Prescription Drugs)

Within the new Cannabis Regulations, Health Canada has introduced a new type of facility license, called a Cannabis Drug License, which allows the license holder to sell a drug product that contains cannabis. In order to achieve this license, a company must also hold a Drug Establishment License (DEL) which is required to manufacture pharmaceutical products. With both of these licenses in hand, a company can compound cannabis with an approved drug. This is not for the faint of heart as the facility must also comply with Canadian pharmaceutical GMP which is more stringent compared to cannabis Good Production Practices.

This license will allow you to sell to another holder of a cannabis drug license, research license, testing license, pharmacist, and practitioner or hospital employee. There will be increased physical security measures if you receive more than 600 kg of dried cannabis per year to compound into prescription drugs.

Canwis cannabis consultants will prepare the following documents:

  • Pharmaceutical facility design

  • Site and physical security design

  • Federal Acts and Regulations

  • Municipal requirements

  • Highly specialized reports on quality assurance

  • Inventory control software

  • Standard Operating Procedures, batch records and in-process quality control logs

  • Drug and cannabis compliance

  • Submit application within Health Canada’s Cannabis Tracking and Licensing System (CTLS)

  • Submit application for a Drug Establishment License