SafetyCall International is now providing a new service focused on adverse event reporting for Veterinary Health Products (VHPs) in Canada. This service coincides with the change in regulatory reporting obligations for Canadian animal supplements. VHPs must comply with Health Canada’s Food and Drugs Act and Regulations, including the Natural Health Products Regulations. These products are regulated by the Veterinary Drugs Directorate (VDD).
VHPs are low risk veterinary drugs in dosage form that are intended to maintain or promote the health and wellbeing of both companion and food producing animals. Examples of these products include supplements, vitamins, minerals, homeopathic, and traditional medicines. VHPs may be administered via topical, oral, otic and dental/periodontal routes. There are specific limitations on ingredient concentrations and requirements for labeling, including mandatory cautions and/or warnings, that apply to active ingredients, homeopathic and traditional medicines, as well as non-medicinal (excipient) ingredients.
To gain approval for a VHP, a company is required to notify Health Canada 30 days before the sale and import of their product. Their product’s ingredients must be included on Health Canada’s List of Permitted Substances for the intended use in that specific species. If not on the list, the company must apply for approval of those specific ingredients or indications. Once authorized, the product will receive a notification number (NN).
After the approval, the company must monitor and maintain records of all adverse events. For serious adverse events occurring in Canada or internationally, the company is required to report them to Health Canada within 15 calendar days. With the help of SafetyCall, our clients will be able to meet these requirements and continue to sell safe animal health products in Canada.