By: Karolina Zarichna, REGULATORY AFFAIRS SPECIALIST, email
Veterinary Health Product Licensing Fee
Effective April 1st, 2020, applicants submitting Veterinary Health Product (VHP) notifications in Canada are subject to a licensing fee. This fee, invoiced by Health Canada, is subject to an annual review to reflect changes in the Consumer Price Index (CPI). Applicants will incur this fee for new notifications and amendments to existing Notification Numbers (NNs).
The applicable fee is invoiced to the product’s notifier via email and must be paid regardless of the directorate’s decision. For instance, if an applicant fails to submit a complete notification form or fails to meet regulatory requirements, the notification form will be rejected. In the event of rejection, the licensing fee will still apply.
As of April 1st, 2024, the Veterinary Health Product notification fee is set at $562 CAD.
Small Business Discounts for Veterinary Health Product (VHP) Notification Fees
Canadian small businesses may qualify for reduced Veterinary Health Product notification fees. To be eligible, a company must meet one of these criteria: have fewer than 100 employees or have a gross annual revenue between $30,000 and $5 million CAD. Qualifying small businesses that register with Health Canada before submitting a Veterinary Health Product notification receive a 50% discount on standard Veterinary Health Product notification fees and a one-time waiver of the fee for their first Veterinary Health Product notification.
When to Submit a Veterinary Health Product Notification
All applicants must notify Health Canada about their Veterinary Health Products (VHPs) at least 30 days prior to selling their products and prior to the product’s import. For changes to already notified products, a notification must also be submitted to Health Canada at least 30 days prior to the change implementation.
Once the notification is processed, Health Canada will issue a notification number for the product and add it to the List of Notified Products.
Veterinary Drug and Veterinary Health Product Registration in Canada
In Canada, it’s important to distinguish between Veterinary Drugs (VDs) and Veterinary Health Products (VHPs). VD are designed specifically to treat, prevent, or cure animal diseases and require a Drug Identification Number (DIN) prior to their sale. Veterinary Health Products, on the other hand, focus on promoting the overall well-being of animals. They contain ingredients such as vitamins, plant extracts, traditional medicines, and homeopathic ingredients. Veterinary Health Products don’t require a DIN, but you must notify Health Canada and obtain a Notification Number (NN).
The Veterinary Drugs Directorate (VDD) regulates both product categories, ensuring that veterinary health products and drugs meet Canadian Veterinary Health Product compliance requirements, which include safety, efficacy, and quality requirements outlined in the Food and Drug Regulations and regulatory documents incorporated by reference.
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