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VDD Authorizes Short-Acting Oxytetracycline for Sale in Canada, Updates Drug Review Process and Terms and Conditions
March 6, 2025
The Canadian Veterinary Medical Association (CVMA) is pleased to share that the Veterinary Drugs Directorate (VDD) recently issued a Notice of Compliance for a short-acting oxytetracycline injectable product for use in cattle, swine, and sheep.
This decision supports our one of our priority efforts to address veterinary pharmaceutical availability challenges and the work of our Pharmaceutical Access Advisory Committee.
The approved product, Engemycin DD, is now visible on the Notice of Compliance Database and the Drug Product Database.
List of Needed Veterinary Drugs
Additionally, the CVMA, with input from the National Veterinary Species groups and other industry groups, provided a list of priority needs for veterinary drugs to the VDD last year. The VDD subjected the list to a triage process to identify a list of drugs that would be given the highest priority for review. This list is now available on the Health Canada website.
VDD Interim Approach for Priority Review of Veterinary Drug Submissions
Health Canada is also updating its priority review policy for veterinary drug submissions. This interim approach will enhance transparency and clarity in the review processes and provide the opportunity for pharmaceutical companies to request priority review for needed drugs.
Notice to stakeholders: VDD Policy on Terms and Conditions for Veterinary Drugs
Terms and conditions (T&Cs) are a tool used to manage known or anticipated risks and significant uncertainties associated with a drug. They also allow certain drugs to be considered for market authorization based on promising evidence of clinical efficacy.
The T&C regulatory authorities for veterinary drugs will come into force on April 1, 2027. In the interim, starting April 1, 2025, the VDD is implementing T&Cs by policy for veterinary drugs that meet certain criteria. This will also expand the type of veterinary drugs that may be reviewed simultaneously with the United States to include drugs seeking conditional approval in that country. Find more information here.