Notice of Intent to Amend the Prescription Drug List: Metamizole (dipyrone) 

January 18, 2022
Our file number: 22-100544-803

The purpose of this Notice of Intent to Amend is to announce that metamizole (also known as ‘dipyrone’) will be added to the Prescription Drug List (PDL). Only the Veterinary part of the PDL will be revised. This addition will be effective 6 months after the posting of this notice.

The new veterinary PDL listing will read:

Drugs containing any of the following: Including (but not limited to): Qualifier Effective Date
Metamizole (dipyrone) or its salts N/A N/A 6 months from the date of this notice

Rationale:

Health Canada received a veterinary drug submission for metamizole (also known as ‘dipyrone’), a pyrazolone non-steroidal anti-inflammatory drug (NSAID). Upon review of the safety and efficacy evidence submitted to Health Canada, it was determined that the following criteria outlined in section C.01.040.3 of the Food and Drug Regulations apply to metamizole:

From April 23, 2021 to July 7, 2021 Health Canada held a consultation on the addition of metamizole to the veterinary PDL. No comments were received in response to the consultation.

This amendment will take effect six months from the date of this Notice of Intent to Amend. On that day, the PDL will be amended and a Notice of Amendment will be posted on the Health Canada website.

As a result of this PDL amendment, veterinary products containing metamizole will be considered prescription drugs subject to the Food and Drug Regulations (FDR), and as such, will no longer be considered non-prescription drugs.

Health Canada has notified the sponsors of the following Drug Identification Number (DIN) products that their products will be affected by this switch:

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Should you have any questions regarding this notice, please contact:

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

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