Health Canada Proposing Changes to Antimicrobial Drug Rules for Livestock


Proposed amendments to Canada’s Food and Drug Regulations were outlined in more detail this week, after a brief announcement by Health Canada on June 30, 2016. The potential changes look to “strengthen rules governing the importation, sale and use of antimicrobial drugs in livestock.”

“Health Canada’s proposal to strengthen the rules around the use of these drugs in livestock is one step we are taking to address the growing public health problem of antimicrobial resistance and to ensure that these drugs remain effective in the years to come,” said Minister of Health Jane Philpott, in a release.

The Food and Drug Regulations (FDR) currently do not provide the necessary regulatory oversight of antimicrobials for veterinary use to mitigate the risk of AMR. – Canada Gazette, July 2.

The changes, as outlined in the Canada Gazette on July 2, are intended to:

  • require veterinary active pharmaceutical ingredients (APIs) imported or sold in Canada to be manufactured in accordance with good manufacturing practices (GMPs);
  • require persons who fabricate, package/label, import or test an API for veterinary use to do so in accordance with an establishment licence (EL);
  • restrict the own use importation of certain unauthorized drugs (including APIs);
  • require manufacturers and importers to provide sales volume information by species for veterinary antimicrobials; and
  • introduce an alternative, more appropriate pathway for manufacturers to legally import and sell low-risk veterinary health products (VHPs)

“The proposed amendments to the FDR are necessary to respond to the serious and growing public health threat of AMR by improving the regulatory oversight of antimicrobials for veterinary use,” reads the article in the Canada Gazette.

If implemented, the changes are anticipated to cost industry and government $41.6 million over the next ten years.

Canadians will have the opportunity to provide feedback over a 75-day consultation period, ending September 14, 2016.

Comments and suggested revisions can be sent directly to the Veterinary Drugs Directorate at [email protected].

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