Navigating the Regulatory Landscape: Selling Veterinary Health Products in Canada 

Veterinary Health Products (VHPs) in Canada play a vital role in promoting the wellbeing of both companion and food producing animals. VHPs in Canada are low-risk products that include vitamins, minerals, probiotics and herbal remedies, and are intended to maintain and support normal health function. 

Registration is a Must 

Before any VHP hits Canadian shelves, it must be registered with Health Canada.  

Since November 13, 2017, Health Canada has regulated VHPs via a Notification Program, run by the Veterinary Drugs Directorate (VDD). This program requires manufacturers, importers, and distributors to notify Health Canada at least 30 days before selling or making changes to a VHP, and to comply with GMPs under the Natural Health Products Regulations.  

The notification process is broken into two phases, the Admin Screening Stage and the Info Verification Stage. In the Admin Screening Stage, they will ensure that the file has all the required information and is formatted in accordance with the program guidelines. You are given up to two opportunities to correct the application in this phase, with each request allowing for 10 days to respond.  

Once the application is deemed “administratively complete”, it moves to the Information review phase. Once it’s moved to this phase, the performance target of 30 days to issue a regulatory decision is started. In this phase, they will review the claims, doses and brand name of the product to ensure it meets the program criteria. If there are questions in this stage, only one request will be sent and you have only 7 days to respond.  

Upon completion of the notification process, you will be issued a Notification Number (NN) that serves as your product’s market authorization. The NN confirms that your product complies with all relevant safety, quality, and efficacy standards. 

Notifications for VHPs are charged a licensing fee (currently CAD 578 as of April 1, 2025), regardless of the success of the application. Small businesses are eligible for 50% discounted applications (and a fully waived fee for the first application) when they register, prior to submission, as a small business with Health Canada.  

Claims Are Limited to “Maintenance of Good Health” 

One of the most crucial aspects of VHP regulation is the nature of the claims that can be made.  

VHPs are designed solely for the maintenance and promotion of good health in animals. Unlike veterinary drugs, they are not allowed to claim the ability to treat, prevent, or cure any disease. Any claims beyond maintaining general well-being would automatically reclassify your product as a veterinary drug, a category that requires a Drug Identification Number (DIN) and a far more rigorous and expensive pre-market approval process.  

Stick to Your Approved Claims 

Once Health Canada reviews and accepts your VHP notification, the approved product claims become part of your NN’s scope and market authorization. It is imperative that you do not make any claims outside of those approved. Any deviation may lead to regulatory actions, including potential product recalls or enforcement measures.  

Your NN is a binding document that outlines exactly what you are allowed to state about your product, so in addition to your labelling, all marketing material (digital and in print) is considered an extension of your label and must remain consistent with this approved information.  

For products that are also sold in other countries, we recommend having a dedicated website for Canada. This will allow you to fully comply with the regulations in Canada, without having to adjust your marketing in other jurisdictions. Please see our related blog on this here: https://delltech.com/blog/online-marketing-canadian-tailored-websites/  

Full Disclosure of Ingredients 

Transparency is key in the VHP notification process. Every ingredient used in your product must be declared on both the notification application and the final product label. Where this may seem obvious at first, companies often are caught off guard when realizing that this includes all active components as well as any excipients, carriers, or other substances present in the formulation or ingredients. This requirement is in place to ensure that Health Canada and end users know exactly what is in your product and can fully assess its safety for the target species. 

While all ingredient amounts must be declared on the product application, only the amounts of the medicinal ingredient must be provided on the product label. In the case of proprietary blends, the VHP program requires the total amount of the blend declared, and then a “not less than” amount of each component. This aims to provide more transparency to the consumer over what exactly is in the blend, without declaring it’s exact formulation.   

Uncertainty in Substance Application Performance Targets 

Each ingredient used in the formulation, must first be found on the list of permitted substances for the species of animal the product is intended for. If it is not already found on that list, you can apply to have it added through a substance application; first through a short substance application, and if VHP does not have enough internal substantiation to allow the ingredient, then a long substance application.  

One of the current challenges is that substance applications have no set performance target. In practical terms, this means that the review period for these applications is unclear—it could take as little as a month or, in some cases, significantly longer. This uncertainty can significantly complicate your product launch timelines.  

Advocacy and Industry Involvement 

Recognizing the challenges inherent in the current regulatory framework, our organization is a member of the Canadian Animal Health Institute (CAHI). As a CAHI member, we are better positioned to advocate for regulatory changes that simplify the approval process and address some of the inconsistencies. Advocacy efforts like these are crucial for ensuring that the regulatory environment keeps pace with scientific advancements and the needs of the industry. A collaborative approach can lead to more rational, risk-based regulations that safeguard animal health while also facilitating market access. 

In Conclusion 

Successfully selling VHPs in Canada requires a robust understanding of the regulatory requirements. From mandatory registration and strict limitations on health claims to comprehensive ingredient disclosure and navigating uncertain review timelines, each step in the process is critical. Working with experienced regulatory consultants and engaging in industry advocacy through organizations like CAHI can help ensure that your products not only comply with current standards but also contribute to a more efficient and scientifically sound regulatory framework. 

By staying informed and proactive, manufacturers and distributors can successfully navigate this complex landscape, ensuring that their VHPs reach the market safely and effectively while upholding the highest standards of animal health and safety.  

Dell Tech has the expertise to help you navigate these applications and help you gain market access. Reach out today with any question about your product, the process or how we can help!  

DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.