Health Canada is introducing two targeted changes to the physical security requirements under the Access to Cannabis for Medical Purposes Regulations (ACMPR) that must be respected by licensed producers (LP) of cannabis for medical purposes.
Health Canada has drawn on four years of experience, and nearly 1000 physical inspections of licensed producers, to determine that the current requirements for physical security under the ACMPR, specifically the requirements that licensed producers maintain a high-security vault for the storage of cannabis products and that areas where cannabis is grown be under constant visual surveillance, do not align with the existing evidence of risks to public health and safety. Since the licensing of the first federally licenced producer in June 2013, Health Canada has not had any cases of diversion of cannabis to the illegal market.
Effective immediately, licensed producers will no longer be required to meet the vault and storage measures outlined in the existing Directive on Physical Security Requirements for Controlled Substances. Instead, licensed producers will be required to store cannabis within a secure area of their facility. This area must be secured with physical barriers, an intrusion detection system, and 24/7 visual monitoring and recording capability. A record of the identity of every person entering or exiting the storage area must be kept, and access to those areas must be restricted to those whose presence is required by their work responsibilities.
In addition, licensed producers will no longer be required to maintain 24/7 video surveillance inside the rooms where cannabis is being cultivated, propagated or harvested. All access points to cultivation, propagation and harvesting rooms will, however, continue to be subject to 24/7 video surveillance and recording in order to record all entries and exits.
Licensed producers will need to continue to meet all the other robust, multi-layered physical security requirements outlined under the ACMPR, namely securing the perimeter of their site in a manner that prevents unauthorized access, ensuring that this perimeter is visually monitored at all times and that intrusion detection systems are installed and operate at all times. All indoor areas where cannabis is present will continue to require physical barriers that prevent unauthorized access, intrusion detection systems, visual monitoring and recordings, and restricted access and entry and exit logs. Strict inventory control measures and regular reporting of cannabis production, inventory and shipments to Health Canada will continue to be required and verified during Health Canada’s inspections of producers, providing another important regulatory control to ensure that cannabis is not diverted to the illegal market.
Finally, licensed producers and applicants must continue to meet all other requirements under the ACMPR, which represents one of the most robust frameworks in the world for ensuring effective control and regulation of the production of cannabis for medical purposes. In addition to security requirements, the ACMPR includes requirements for Good Production Practices, which help provide individuals with access to quality-controlled cannabis for medical purposes. Compliance is verified during inspections by Health Canada inspectors.
The introduction of these two targeted changes will help ensure that the physical security requirements imposed on licensed producers continue to align with the evidence of actual risks to public safety and do not impose an unjustifiable burden on regulated parties. These changes follow several improvements that Health Canada introduced in May 2017 to streamline the application process for issuing production licenses and enable increased production of cannabis for medical purposes under the ACMPR.
Health Canada will continue to work closely with patients, patient advocates and licensed producers to identify and act on opportunities to improve access to cannabis and service to Canadians.