Notice of Amendment: Tramadol removed from the Prescription Drug List (PDL)

March 31, 2022
Our file number: 22-103686-802

The purpose of this Notice of Amendment is to notify that Health Canada has removed tramadol from the Prescription Drug List (PDL) and added it to Schedule I of the Controlled Drugs and Substances Act (CDSA) and to the Narcotic Control Regulations (NCR). Both the Human and Veterinary parts of the PDL were revised.

On March 31, 2021, Health Canada published in Canada Gazette, Part II, the addition of tramadol as a controlled substance and narcotic to Schedule I of the CDSA and to the NCR. A Notice of Intent to Amend the PDL listing of tramadol was also published. This change comes into effect today, March 31, 2022.

These regulatory amendments are intended to provide additional safeguards around the use of tramadol to help prevent problematic substance use and other harms, while also protecting access to these medications for patients who need them.

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 that accompanies the Regulations Amending the NCR.

Next steps

In order to facilitate the transition and avoid disruption in market access, any products already sold and distributed by manufacturers prior to March 31, 2022, or product remaining at wholesalers or pharmacies, may continue to be sold with existing labelling until market depletion. In accordance with the CDSA, patients can continue to obtain tramadol from a practitioner or by a written prescription, but verbal prescriptions or refills are no longer permitted for tramadol products marketed in Canada. Patients who would have otherwise obtained a prescription verbally or with refills will need to see their doctor to be reassessed so a decision can be made with respect to whether the patient should continue with the medication and receive a prescription.

Tramadol products sold and distributed by manufacturers after March 31, 2022 must include the updated labelling with the "N" narcotic symbol. Market authorization holders who have questions surrounding the impact of this amendment should contact:

For any other questions regarding this notice, please contact:

Health Canada
Therapeutic Products Directorate
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca

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