Product classification is often one of the most critical determinants of successful market entry, as it defines the applicable regulatory framework and, in turn, the pre-market requirements needed to demonstrate compliance. This principle applies equally to pet products. Early classification is essential to determine whether a product is a Veterinary Health Product (VHP) or a veterinary drug, since product classification directly impacts permissible claims, product formulation, and the evidentiary expectations.
This article outlines the key differences between VHPs and veterinary drugs, with a focus on how product elements influence classification. It also reviews the types of claims typically permitted within each category, ingredient considerations, and other development and launch factors that should be evaluated before finalizing product formula, labelling, and go-to-market strategy.
- How Health Canada Defines VHPs and Veterinary Drugs
- Intended Use and Claims in Classification Determination
- Ingredients, Mechanism, and Risk in Product Classification
- Product Labelling and Category Identifications for VHPs and Veterinary Drugs
- Determining Whether a Product Is a VHP or a Veterinary Drug
- Final Remarks
- FAQ
- Do Veterinary Health Products (VHPs) require clinical studies?
- What is the difference between a Notification Number (NN) and a Drug Identification Number (DIN)?
- Do VHPs require the same manufacturing licences as veterinary drugs?
- Can a product move from the VHP pathway to the veterinary drug pathway?
- What are common reasons products are misclassified?
How Health Canada Defines VHPs and Veterinary Drugs
Both VHPs and veterinary drugs sit under the Food and Drugs Act and Food and Drug Regulations, but Health Canada manages them through different systems.
Veterinary Health Product (VHP) Definition
VHPs are low risk drugs in dosage form intended to maintain or promote the health and welfare of companion and food producing animals. They are not intended for the diagnosis, treatment, prevention, or cure of disease. In Canada, these products are regulated through Health Canada’s VHP Notification Program. All medicinal and non-medicinal ingredients must appear on the List of Permitted Substances for Veterinary Health Products (List C) and must comply with the applicable conditions of use, including permitted species, dosage form, maximum levels, and required cautionary statements. If a product contains a substance that does not appear on List C, a New Substance Application must be submitted, and the substance must be added to the list before the product can proceed through the notification process.
Companies must notify Health Canada at least thirty days before selling or importing a VHP and must attest that the product complies with all program requirements. Health Canada reviews the notification and issues a Notification Number (NN) once compliance has been confirmed. This number must appear on the product label along with the required labelling elements. Although VHPs do not receive a Drug Identification Number (DIN), they remain subject to program oversight, including ingredient eligibility requirements, labelling standards, adverse reaction reporting, and quality related expectations appropriate for products classified as low risk.
Veterinary Drugs Definition
Veterinary drugs in Canada are regulated under the Food and Drugs Act and the Food and Drug Regulations and must undergo a comprehensive pre-market review by Health Canada prior to sale. Depending on the product and regulatory pathway, sponsors may submit a New Drug Submission (NDS), Supplemental New Drug Submission (SNDS), Abbreviated New Drug Submission (ANDS), or Supplemental Abbreviated New Drug Submission (SANDS) to Health Canada’s Veterinary Drugs Directorate (VDD). Through this process, the Directorate evaluates the safety, efficacy, and quality of veterinary drugs for their intended species and conditions of use. While all pathways require complete and consistent product labelling, the scope of supporting information varies by submission type. For example, NDS applications generally include a full data package addressing target animal safety, effectiveness, chemistry and manufacturing controls, stability, and, where applicable, residue depletion and withdrawal periods for food-producing animals.
Because veterinary drugs are intended for therapeutic use, they are subject to rigorous pre-market evaluation and must be marketed with labelling that reflects the authorized conditions of use. Health Canada reviews the supporting evidence to confirm that the proposed claims and conditions of use are appropriately substantiated and consistent with the regulatory framework. Once authorized, veterinary drugs remain subject to ongoing regulatory oversight, including adverse reaction reporting, pharmacovigilance activities, and compliance monitoring to ensure continued alignment with their approved status.
Intended Use and Claims in Classification Determination
Intended use is one of the primary factors that Health Canada uses to distinguish a VHP from a veterinary drug. This determination is based on how a product is represented, including its label claims, advertising, directions for use, and stated purpose. When a product is represented to exert therapeutic, preventive, or diagnostic effects, it is regulated as a veterinary drug rather than a VHP.
Intended Use Aligned with VHPs
A product may fall within the VHP pathway when its intended use is non-therapeutic in nature. Under the VHP framework, eligible products support normal physiological function in otherwise healthy animals and do not exert pharmacological effects associated with therapeutic use.
Claims for VHPs must therefore use low risk, non-therapeutic language such as “helps maintain digestive function,” “supports normal joint health,” or “contributes to overall immune function,” provided the wording does not imply disease outcomes or corrective effects. For example, a probiotic blend for dogs described as “supports digestive health” may remain within the VHP pathway, whereas a representation such as “treats diarrhea” would shift the product into the veterinary drug category.
Intended Use Aligned with Veterinary Drugs
Veterinary drugs are products represented for therapeutic use. Claims that indicate disease modification, symptom resolution, parasite control, or any form of therapeutic or preventive action place a product within the veterinary drug category.
For veterinary drugs, claim language must align with the data submitted in the drug application and remain consistent with the evidence reviewed and approved by the VDD. Examples include statements such as “treats respiratory infection,” “prevents flea infestations,” or “controls bacterial enteritis,” each of which communicates a therapeutic purpose.
Maintaining internal review processes and claim matrices helps teams ensure that proposed language accurately reflects therapeutic intent while remaining compliant with the authorized conditions of use.
Ingredients, Mechanism, and Risk in Product Classification
Classification is influenced not only by the claims a product makes but also by what is inside the formulation and how those ingredients function once administered. Both the substance and its intended action shape how the regulatory framework interprets risk and determines the appropriate pathway for market entry.
List of Permitted Substances for Use in VHPs
For a product to qualify as a VHP, every medicinal and non-medicinal ingredient must appear on Health Canada’s List of Permitted Substances and comply with the specific conditions assigned to each entry. The list includes active, homeopathic, and traditional medicine substances which Health Canada has evaluated and determined to be low risk when used as directed. It also includes acceptable non-medicinal ingredients, such as flavours, carriers, and preservatives, each with defined specifications and limitations. If a substance falls outside the permitted entries, or the listed specifications, the product cannot proceed through the VHP pathway without undergoing a separate pre-notification substance assessment.
Permitted Ingredients for Use in Veterinary Drugs
Veterinary drugs, in contrast, are not bound to a predetermined list of eligible ingredients. These products can include active pharmaceutical ingredients and a broad range of excipients, but each component must be fully characterized, justified, and supported within the drug submission. Under the regulations, safety, efficacy, and quality must be demonstrated for both the active ingredient and the finished formulation. This involves data that explain how the active ingredient produces its intended pharmacologic effect, evidence supporting the proposed indication and target species, and manufacturing information showing the product meets applicable quality standards. Because veterinary drugs are designed to exert therapeutic effects, their risk profile is inherently higher, which is why the regulatory oversight is correspondingly more rigorous, extending through both pre-market evaluation and post-market monitoring.
Product Labelling and Category Identifications for VHPs and Veterinary Drugs
When assessing an already existing pet product for entry into the Canadian market, the label is often the first touchpoint used to understand how the product is represented. Although this label will be update prior to sale in Canada, it still offers important cues about a product’s identity. The tone, imagery, formatting, and overall presentation of the current label is often used to determine whether a product fits the VHP or veterinary drug classification.
Visual and Structural Elements That Align with VHP Classification
Labels that convey general wellness, maintenance support, or routine care typically align more naturally with VHP classification. Imagery such as healthy pets in everyday settings, icons depicting general functions (for example, mobility, skin and coat, or digestion), and diagrams illustrating normal physiological processes all reinforce a non-therapeutic applications. Layouts that resemble nutrition style panels, supplement formats, or holistic wellness products also tend to point toward low-risk positioning. While these visual elements will not determine classification on their own, they support the interpretation that the product is meant to promote or maintain normal function rather than correct a medical problem.
Visual and Structural Elements That Shift a Product Toward Veterinary Drug Classification
In contrast, certain visual or stylistic cues on an existing label can suggest therapeutic intent even when explicit claims are not made. Imagery showing anatomical diagrams, organ specific targeting, before and after illustrations, or depictions of symptom resolution can shift the product into a drug classification. Labels that adopt clinical or pharmaceutical elements, such as medical icons or symbols, charts that imply performance correction, or before and after imagery may signal a therapeutic purpose. These cues, when taken together with other labels elements, can shift the product toward veterinary drug classification.
Therefore, when assessing an existing label for classification purposes, the overall visual impression becomes an important contextual signal. Wellness-oriented imagery, neutral diagrams, and supplement-style layouts help support a VHP interpretation, whereas clinical aesthetics, anatomical targeting, or visuals implying corrective outcomes shift the product toward veterinary drug status. Although these elements do not independently determine classification, they influence how the product’s intended use is understood and can meaningfully affect whether the product should follow the simplified VHP notification pathway or requires full veterinary drug authorization prior to market entry.
Determining Whether a Product Is a VHP or a Veterinary Drug
The elements discussed earlier in this article collectively influence product classification. While certain factors can strongly influence classification, product elements are rarely assessed in isolation. In most cases, intended use, claim language, ingredient eligibility, and product format must be considered together to determine the most appropriate classification and the regulatory requirements that must be met prior to sale.
The following section recaps the key points discussed above and provides a quick checklist that can be used as a preliminary product assessment.
Product’s Intended Use
Products intended to maintain or promote normal health in otherwise healthy animals, and that use only ingredients and claim language permitted for VHP, generally fall within the VHP pathway. Formulations that reference the treatment, prevention, or diagnosis of disease or abnormal conditions meet the definition of a veterinary drug.
Ingredients Used in the Product
Formulations that rely on substances not included in the List of Permitted Substances, and that cannot be added through a New Substance Notification, will not qualify as VHP. Pharmacologically active ingredients fall outside the low-risk scope of VHPs and are used only in authorized veterinary drugs. Veterinary drugs do not rely on a predefined ingredient list, and their ingredients are assessed through the evidence submitted in support of a DIN application.
Product Labelling and Category Identification
Product labelling can reinforce how a pet product is interpreted. Labels that present the product within a general wellness or maintenance context tend to support VHP positioning. In contrast, labels that adopt clinical or pharmaceutical style elements, anatomical targeting, or visuals implying symptom correction can suggest therapeutic intent. While these elements do not independently determine classification, they can influence how the product’s intended use is interpreted and may shift the product toward veterinary drug regulation.
Alignment of Product Elements
In practice, product classification must be assessed at the product level. The appropriate regulatory pathway becomes clearer once intended use, claim language, and ingredient eligibility are considered together. When all three align with the conditions established for VHP, the product can proceed through the VHP Notification Program.
If any element indicates therapeutic intent or relies on ingredients outside the permitted scope, the product may instead be regulated as a veterinary drug and require authorization, including the issuance of a DIN, before it can be sold in Canada.
Final Remarks
Product classification is ultimately the foundation of regulatory strategy for pet products entering the Canadian market. As outlined throughout this article, the distinction between VHPs and veterinary drugs depends on how the product is represented, what ingredients it contains, and how those ingredients are intended to function. Intended use, claim language, ingredient eligibility, and overall product presentation must be considered together to determine the appropriate regulatory pathway and the level of oversight required prior to sale.
Establishing the correct classification early in product development allows companies to design formulations, claims, labelling, and supporting documentation that align with the applicable regulatory framework. When product elements remain within the low-risk scope defined for VHPs, the product may proceed through the VHP Notification Program. When therapeutic intent or pharmacologically active ingredients are involved, the product will fall under the veterinary drug framework and require full pre-market authorization from Health Canada. Conducting this assessment at the outset can help reduce development delays, prevent misclassification, and support a more efficient and compliant path to market.
SNI’s Regulatory Services for VHP and Veterinary Drug Classification
The SNI Regulatory Team works closely with companies developing regulated products to ensure that formulations, claims, and labelling align with the applicable regulatory framework before products enter the market. By integrating regulatory strategy early in the development process, our team helps identify classification considerations, ingredient eligibility requirements, and claim limitations before they create delays in commercialization. This proactive approach reduces the risk of misclassification, streamlines the regulatory pathway, and supports efficient product approvals across regulated categories.
⬇️ Send us a request to learn more about labelling solutions
FAQ
Do Veterinary Health Products (VHPs) require clinical studies?
Clinical studies are not required to be submitted to Health Canada for VHP notifications. However, companies must hold evidence supporting the product’s safety and effectiveness when used as directed. This evidence must be maintained by the company and may be requested by Health Canada if compliance questions arise.
What is the difference between a Notification Number (NN) and a Drug Identification Number (DIN)?
A Notification Number (NN) is issued for products notified through the VHP Notification Program and confirms that the notification has been accepted. A Drug Identification Number (DIN) is issued only after Health Canada completes a full scientific review and approves a veterinary drug under the Food and Drug Regulations.
Do VHPs require the same manufacturing licences as veterinary drugs?
No. Veterinary drugs must be manufactured by companies holding a Drug Establishment Licence (DEL) and must comply with the Good Manufacturing Practices in Part C, Division 2 of the Food and Drug Regulations. VHPs do not require a DEL but must still be produced under applicable quality controls.
Can a product move from the VHP pathway to the veterinary drug pathway?
Yes. Changes to claims, ingredients, or intended use can shift a product from the VHP pathway to the veterinary drug framework. If therapeutic claims or pharmacologically active ingredients are introduced, the product will require veterinary drug authorization and a DIN.
What are common reasons products are misclassified?
Common issues include therapeutic claim language, ingredients not listed on the List of Permitted Substances for Veterinary Health Products, or labelling that implies disease treatment. These elements can shift a product from the VHP pathway to veterinary drug regulation.
