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Health Canada Updates: Antimicrobial Resistance and Administrative Forms

January 12, 2018

Health Canada has provided updates made to its Canada.ca web site on antimicrobial resistance (AMR) and its administrative forms. Although, the new rules for annual sales reporting of medically important antimicrobials (MIAs) for veterinary use and the updated forms for all types of veterinary drug submissions and applications only affect industry/manufacturers, it is important for veterinarians to be aware of the changes.

More information has also been added to the Responsible use of Medically Important Antimicrobials in Animals of the Government of Canada’s website, reminding everyone that there are changes that will require affected drugs and dosage forms to be sold by prescription, which come into effect on December 1, 2018.

See Health Canada Update below:

Antimicrobial Resistance (AMR)

  1. Health Canada’s new rules for annual sales reporting of medically important antimicrobials (MIAs) for veterinary use (i.e. those considered important in human medicine), which helps support its surveillance program and the interpretation of patterns and trends of AMR.

    The May 17, 2017 final publication in the Canada Gazette, Part II of the Regulations Amending the Food and Drug Regulations (Veterinary Drugs – Antimicrobial Resistance) includes an annual sales reporting requirement for manufacturers, importers and compounders of drugs for veterinary use that contain an active pharmaceutical ingredient on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients.

    The first reporting year is 2018, where the sales data from January to December 2018 will need to be submitted by March 31, 2019. Refer to the updated Veterinary antimicrobial sales reporting section of Canada.ca for additional information about the rules.

    Please email the Veterinary Drugs Directorate (VDD) at hc.vamsr-vamvr.sc@canada.ca if you would like more information on the specific sales reporting data requirements. Please note that an electronic data collection tool is being considered in collaboration with the Public Health Agency of Canada (PHAC) to facilitate e-reporting. More information on this initiative will follow.
  2. The Notice of Intent to Amend the Prescription Drug List (PDL) for human and veterinary antimicrobials:
    On December 15, 2017, Health Canadas posted a Notice of Intent to Amend the Prescription Drug List (PDL): Human and Veterinary Antimicrobials. This is further to our collaborative efforts with stakeholders to promote the responsible use of MIAs in animals. The Canada.ca web page on the Responsible Use initiative has also been updated accordingly.

    It is important to note that these changes that will require affected drugs and dosage forms to be sold by prescription will come into effect on December 1, 2018 through a Notice of Amendment to the PDL on Canada.ca.

Administrative Forms:

3. Updated Forms for all types of veterinary drug Submissions and Applications
Health Canada is also pleased to announce that some new and updated forms related to veterinary drug submissions and applications have been posted on Canada.ca to help sponsors and other stakeholders with the submission process.