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Key Updates for Veterinary Drug Stakeholders
February 18, 2022
1. Consultation on draft veterinary drug labelling guidance document
We are pleased to inform you that we will be launching a 60-day consultation on new draft labelling guidance document for veterinary drugs. This guidance intends to provide directions on how to meet the requirements of the Food and Drugs Act and Regulations for veterinary drug labelling and packaging. Details will be communicated to stakeholders once it is launched in the coming weeks.
2. Veterinary Antimicrobial Sales Reporting (VASR)
The 4th reporting cycle of the Veterinary Antimicrobial Sales Reporting (VASR) system is open for companies, importers and individuals compounding antimicrobials on List A intended for use in animals, to submit their 2021 sales data until March 31, 2022. For more information on the sales data, refer to the 2018 and 2019 antimicrobial sales Highlights Reports. The 2020 Highlights Report has also been published recently.
3. Veterinary Health Products (VHPs) in livestock feeds
Following the interim pilot to allow limited VHPs to be mixed in livestock feeds 12 VHPs have been notified and the guidance for feed manufacturers (VHP Compendium) listing all notified VHPs has been published. Health Canada and the CFIA have received feedback from stakeholders on the pilot and we will be providing follow up to stakeholders in the coming month.
4. Updated List C: Veterinary Health Products (VHPs)
List C has been updated with 28 new substances as well as 34 modifications to existing substances, providing further access to VHPs. The List now has a total of 807 active substances, including 310 for food producing animals.
5. List A – Notice of Consultation
We will be making updates to List A: List of certain antimicrobial active pharmaceutical ingredients. This will include a 90-day public consultation on Health Canada’s website on the proposed additions and revisions. The consultation is expected to open in February and a notice will be communicated to stakeholders once the link is live.
6. Publication of 2019-2020 Compliance Monitoring Project
The Regulatory Operations and Enforcement Branch’s 2019-2020 Compliance Monitoring Project, which examined good manufacturing practices and testing of veterinary products for food-producing animals, will be published this February. Overall, 9 companies and 6 products were tested to verify compliance, compliance issues ranging in severity were found at most companies. Findings provide better guidance to industry on how to meet regulatory requirements, improves Health Canada’s oversight, including the quality and safety of veterinary products in Canada.
7. Status quo remains for the requirement of annual summary report of adverse drug reaction
As of January 28, 2022, the European Medicines Agency (EMA) has implemented their New Veterinary Regulation and Guideline on Veterinary Good Pharmacogivilance Practices (VGVP guideline) and will no longer require drug manufacturers among all European Union Member States to prepare and submit periodic summary update reports (PSURs) on a regular basis.
The Veterinary Drugs Directorate continues to require summary reports to inform drug evaluation and support signal detection as per the Canadian Food and Drug Regulations. In the interest of international harmonization, VICH Guideline 29 remains the preferred format; however, there will continue to be flexibility where required or requested.