Notice of intent to amend: Prescription Drug List (PDL): Tramadol

March 31, 2021
Our file number: 21-106063-491

The Prescription Drug List (PDL) is a list of medicinal ingredients that when found in a drug, require a prescription. It does not include medicinal ingredients that are listed on Controlled Drugs and Substances Act (CDSA) Schedules. When ingredients are added to the CDSA and associated regulations they are removed from the PDL.

From April 20, 2019 to June 18, 2019 Health Canada held a consultation on the regulatory status of tramadol through a Canada Gazette, Part I, publication. Stakeholders were consulted on the addition of tramadol to Schedule I to the CDSA and to the Narcotic Control Regulations (NCR). The comments received were assessed and the decision was made to implement the proposed change.

On March 31, 2021, Health Canada published in Canada Gazette, Part II, the addition of tramadol to Schedule I of the CDSA and to the NCR. These additions will take effect in one year on March 31, 2022. The consultation summary from the Canada Gazette I tramadol publication can be found in the Canada Gazette II tramadol publication.

The purpose of this Notice of Intent to Amend is to notify stakeholders that Health Canada will remove tramadol from both the Human and Veterinary parts of the PDL when the above-mentioned additions to the CDSA and NCR take effect.

Consultation summary:

The proposal to amend the PDL in relation to tramadol was communicated through a Notice of Consultation posted on Health Canada's website on April 24, 2019.

Rationale

Tramadol is a synthetic opioid analgesic that has been marketed in Canada since 2005. It is regulated under the Food and Drugs Act (FDA), and is available by prescription only. Like other opioid analgesics, while tramadol can provide effective pain relief for some patients, it has potential for problematic use and chronic use of tramadol can lead to tolerance and dependence. Tramadol can also cause harmful adverse effects that pose risks to human health, which can be fatal in some cases. Tramadol is suspected to have contributed to 18 reported deaths in Canada between 2006 and 2017.

The full rationale for this amendment can be found in the Regulatory Impact Analysis Statement published in Canada Gazette I on 20 April 2019.

We invite market authorization holders to contact the Therapeutic Products Directorate - Bureau of Cardiology, Allergy and Neurological Sciences (TPD-BCANS), and the Drug Strategy and Controlled Substances Programme - Office of Controlled Substances (DSCSP-OCS) for questions surrounding the impact of this amendment on their product.

• TPD-BCANS: hc.bcansenquiries.sc@canada.ca
• DSCSP-OCS: hc.cds-sdc.sc@canada.ca

Should you have any questions about this Notice of Intent to Amend please contact:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9