Notice: Prescription Drug List (PDL): Naloxone Qualifier Change

February 2, 2017
Our file number: 17-101266-74

The purpose of this Notice of Amendment is to notify that Health Canada has revised the Qualifier for Naloxone on the Prescription Drug List. The listing now reads:

Drugs containing any of the following: Naloxone or its salts

Including (but not limited to): Naloxone hydrochloride

Qualifier: Except when indicated for emergency use for opioid overdose

Effective Date: date of this Notice

Summary:

The proposal to amend the PDL was communicated to provincial and territorial ministries of health, medical and pharmacy licensing bodies, consumer and professional associations, industry and the public through a Notice of Consultation posted on Health Canada's website on January 24, 2017. The 48-hour consultation period which ended January 26, 2017 has been completed.

Further to this Notice, Health Canada will be developing a Questions & Answers document, and will work with sponsors to modify their Product Monographs to align with this change in qualifier.

Should you have any questions on this update to the Prescription Drug List, please contact:

Prescription Drug Status Committee
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9

Email: drug prescription status
Phone: 613-957-1058
Fax: 613-941-1812