Notice of Amendment: List of Opioids (Part A): Buprenorphine and Methadone

Date: October 1, 2018

The purpose of this Notice of Amendment is to notify stakeholders that Health Canada has amended Part A of the List of Opioids. A qualifier has been added to the list to exempt buprenorphine and methadone from the patient information handout and warning sticker requirement when these drugs are authorized and used for the treatment of an opioid use disorder.

Part B of the List of Opioids will remain unchanged.

The listing in Part A now reads:

Drugs intended for human use containing any of the following active ingredients: Buprenorphine; Methadone

Including (but not limited to): Buprenorphine hydrochloride; Methadone hydrochloride

Qualifier: Except when authorized and used for the treatment of an opioid use disorder

Effective Date: Date of this Notice

Should you have any questions on this amendment, please contact the regulatory project management section at:

Marketed Pharmaceuticals and Medical Devices Bureau
Marketed Health Products Directorate
Health Canada
Address Locator 1912A
200 Eglantine Driveway
Ottawa, Ontario
K1A 0K9

E-mail: hc.mpmdb.rpm-bppmmc.gpr.sc@canada.ca

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