Forward Regulatory Plan 2020-2022: Regulations amending Schedule I to the Controlled Drugs and Substances Act and the Schedule to the Narcotic Control Regulations to add tramadol and related substances

Title of Regulatory Initiative

Regulations amending Schedule I to the Controlled Drugs and Substances Act and the Schedule to the Narcotic Control Regulations to add tramadol and related substances

Enabling Act

Controlled Drugs and Substances Act

Description

Tramadol is an opioid analgesic (pain reliever) that is currently available by prescription in Canada. Like many opioids, tramadol has potential for problematic use, and can produce adverse effects that can pose serious risks to human health.

Scheduling tramadol under the Controlled Drugs and Substances Act (CDSA) and the Narcotic Control Regulations would make it subject to the same regulatory requirements already in place for other opioid analgesics. This would strengthen surveillance of tramadol prescribing practices, and provide Canadian law enforcement agencies with the authority to take action against unauthorized activities with that substance. Tramadol would continue to be available for legitimate medical and scientific use. The proposed regulatory amendment would not affect the way that patients currently access this prescription medication.

Regulatory cooperation efforts (domestic and international)

While there is no international obligation to control tramadol, it is regulated as a controlled substance in some jurisdictions, including the United States (Schedule IV to the Controlled Substances Act) and the United Kingdom (class C, Schedule II to the Misuse of Drugs Act 1971).

Controlling tramadol under the CDSA would align Canadian regulations with those jurisdictions.

Potential impacts on Canadians, including businesses

The regulatory amendment applies to the health care sector and strengthens surveillance of tramadol prescribing practices, and provide Canadian law enforcement agencies with the authority to take action against unauthorized activities with that substance.

Stakeholders that may be impacted by the change include pharmacies, industry, Canadians and health professionals.

Consultations

Notice to Interested Parties was published in Canada Gazette, Part I, on June 16, 2018 and initiated a 60-day public comment period.

Canadians had the opportunity to provide further comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which started on April 20, 2019, and lasted 60 days.

Information on previous consultations and details on upcoming opportunities for consultation in the area of controlled substances can be found on the Canada.ca website.

Further information

Additional information can be requested from the Departmental contact.

Departmental contact

Carol Anne Chenard
Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada

Telephone: 613-410-3793
Email: hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

October 1, 2018

Consult Health Canada's acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada's implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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