Veterinary Health Products (VHPs) are low-risk drug products administered to companion animals or food-producing animals to promote or maintain their health. VHPs are overseen by Health Canada (specifically the Human Safety Division of the Veterinary Drug Directorate) that utilizes a Notification Program to review applications for products to become a VHP based on their safety, efficacy, and quality. Products that Health Canada considers acceptable to be a VHP are granted a Notification Number (NN), composed of the prefix NN and followed by 4 digits, that is to be on their VHP label.
If you have an animal-intended product with benefits for health that you are considering selling on the Canadian market, please keep the following five considerations in mind as your product may be eligible to be notified as a VHP:
1. Type of Claims: VHP claims are limited to those to maintaining or promoting good health (such as claims relating to structure or function). VHPs are not permitted to claims about curing, treating or preventing diseases.
2. Route of Administration: Due to their low-risk nature, VHPs are limited to products that are orally (via mouth), topically (via skin), dental (via teeth) or otic (via ear). Intravenous and suppository products for animals are not eligible for VHPs.
3. Species: The list of species that VHPs can be used for is quite exhaustive and include cats, dogs, horses (both non-food and food type), cattle (both beef or dairy type), pigs, sheep, goats, poultry (Chickens, Turkeys), fish (both shell-fish and ones with fins), honey bees and even camels.
4. Composition: VHPs are generally composed of ingredients such as vitamins, minerals, botanicals, traditional ingredients (including those in Traditional Chinese Medicine) and even homeopathic ingredients with a history of safe use. For complete transparency, the VHP Notification Program has created a List of Permitted Substances, which names all of the ingredients that are permitted in a VHP and potential restrictions and mandatory label statements. If not present, the ingredient may have to be added via a Substance Application.
5. Manufacturing Practices: To be a VHP, the animal product will have to be manufactured according to the standards set out in Part 3 – Good Manufacturing Practices (GMPs) in the Natural Health Products Regulations.
If you’re unsure whether your product could be classified as a VHP (or alternately as a standard veterinary drug, animal feed, or pesticide), please contact us and we’ ll help you determine the correct regulatory class for your animal product(s). dicentra provides highly-sought regulatory and scientific guidance on products for animals and for human-use products as well. We assess marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in the North American marketplace. We can advise of the timelines and requirements for what regulatory product best suits your product, safeguard your product to best avoid any non-compliance issues, and be with you every step of the way to bring your product to market and beyond.