Regulatory Focus™ > News Articles > Health Canada to Require Precautionary Statements in Antimicrobial Labels

Health Canada to Require Precautionary Statements in Antimicrobial Labels

Posted 16 November 2015 | By Zachary Brennan 

Health Canada to Require Precautionary Statements in Antimicrobial Labels

As part of efforts to encourage the more prudent prescribing and use of antimicrobials, Health Canada on Monday announced it will now require the inclusion of precautionary statements in antimicrobial product labelling.

The proposal, which was announced alongside the kickoff of World Antibiotic Awareness Week, comes as bacteria are increasingly stronger, more resistant to antibiotics and therefore more lethal. As part of its federal action plan on antimicrobial resistance, Health Canada says it will require drug sponsors’ monographs to be updated as follows:

Part I: Indications and Clinical Use

"To reduce the development of drug-resistant bacteria and maintain the effectiveness of Product X and other antibacterial drugs, Product X should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy."

Part II: Warnings and Precautions

"Prescribing Product X in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria."

Part III: Patient Medication Information

"Antibacterial drugs like Product X treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Product X should be taken exactly as directed. Misuse or overuse of Product X could lead to the growth of bacteria that will not be killed by Product X (resistance). This means that Product X may not work for you in the future. Do not share your medicine."


As far as industry implementation of these changes, Health Canada noted that existing antimicrobials will be updated “in a phased manner in response to a specific request by Health Canada to the relevant sponsor.”

Health Canada also will be sending an advisement letter to sponsors in a phased manner over the coming months to request a labelling update. “Sponsors should wait until they receive the request from Health Canada so as to facilitate workload management,” the regulator says.

In addition, sponsors of products that do not have a “Prescribing Information” document and/or a Part III: Patient Medication Information component, should create one and file it with their submission. And if a submission is being filed for other reasons than the inclusion of the precautionary statements, sponsors may update their product monograph(s), the regulator says.

Health Canada Notice

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.