Compliance and Enforcement of the Access to Cannabis for Medical Purposes Regulations
Health Canada conducts routine inspections of licensed producers to verify their ongoing compliance. When specific complaints are received, Health Canada may also conduct compliance verifications.
Compliance is normally achieved through a cooperative approach between the regulated party and Health Canada. It is expected that licensed producers of cannabis for medical purposes will take timely and appropriate corrective actions when any issue of non-compliance with the Access to Cannabis for Medical Purposes Regulations (ACMPR) is brought to their attention.
Health Canada conducts compliance and enforcement activities of licensed producers to ensure compliance with the regulations of the Controlled Drugs and Substances Act. These activities include education, compliance verifications, and inspections of licensed producer sites or the sites of parties applying to become a licensed producer.
The Government of Canada developed the Access to Cannabis for Medical Purposes Regulations (ACMPR) with the aim of treating cannabis in a manner similar to other narcotics used for medical purposes. The ACMPR allow for the licensing of qualified licensed producer applicants to produce and distribute cannabis for medical purposes.
In addition to the requirements of the ACMPR, licensed producers are required to comply with all applicable provincial, territorial, and municipal legislation and regulations, including zoning restrictions. Licensed producers are licensed and regularly inspected by Health Canada. Health Canada is responsible for ensuring compliance with the ACMPR; however, municipal authorities remain responsible for enforcing municipal by-laws.
In addition, where appropriate, Health Canada works with partners including the Royal Canadian Mounted Police (RCMP), local law enforcement, Canada Border Services Agency, and professional regulatory bodies to ensure that controlled substances (including cannabis) are handled effectively, and remain within legal distribution channels. As appropriate, Health Canada refers illegal activity to the appropriate authorities.
Guidance for Licensed Producers
Health Canada has developed guidance documents and information bulletins which can be found at Cannabis Regulations for Licensed Producers
Health Canada is also currently developing guidance documents for industry, such as:
- Cannabis for Medical Purposes Recall Guide and Reporting Form
- Compliance and Enforcement Policy
Regulatory Transparency and Openness
Under the Regulatory Transparency and Openness Framework and Action Plan, Health Canada is making more information on compliance and enforcement activities available to Canadians.
Licensed producers must establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of cannabis that has been made available for sale. In the case of a recall, Health Canada must be notified. All recalls are posted in the Recalls and Safety Alerts section of the Healthy Canadians web site.
Complaints related to the ACMPR are received and reviewed by Health Canada. High-risk complaints receive priority attention, but not all complaints lead to further action from Health Canada.
Complaints related to the quality and/or safety of a health product, and trade complaints related to the products and/or the activities of a competitor may be submitted via email to CMC@hc-sc.gc.ca.
For other types of complaint, please refer to the following table for the appropriate contact information.
|Customer service concerns for a licensed producer||Complaints concerning the service received from a licensed producer, such as delays in shipping, billing and cost questions, etc., should be directed to the licensed producer.||List of Licensed Producers|
|Adverse reactions in humans (side effect of cannabis for medical purposes)||All suspected adverse reactions (ARs) to cannabis for medical purposes should be reported to the Canada Vigilance Program.||Canada Vigilance Regional Office|
|Special Access Programme (SAP) to Drugs and Health Products||Healthcare Professionals can request access to health products which are unavailable for sale in Canada.||SAP-Drugs|
|Suspected Illegal Grow Operations||Complaints concerning suspicion that someone may illegally be growing cannabis.||Contact local law enforcement|
|Complaints concerning practice of medicine||Complaints concerning the practice of medicine should be submitted to the respective provincial College of Physicians and Surgeons.|
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