2024 Veterinary Health Products (VHPs) – Notification Process Overview
By: Karolina Zarichna, REGULATORY, BUSINESS DEVELOPMENT & MARKETING SPECIALIST, email
Veterinary Health Product (VHP) Definition
Veterinary Health Products (VHPs) are designed to promote and maintain the overall health and well-being of animals. They contain a variety of natural ingredients like vitamins, plant extracts, minerals, traditional medicine substances, and homeopathic substances. Unlike veterinary drugs that treat and cure diseases, VHPs are considered low risk drugs and do not require a Drug Identification Number (DIN).
VHP Regulations in Canada
Veterinary health products are regulated by Health Canada’s Veterinary Drugs Directorate (VDD) through a pre-market and post-market regulatory approach. This ensures that all products meet the safety, efficacy, and quality requirements outlined in the Food and Drugs Regulations (FDR).
Manufacturers and importers of veterinary health products must submit a notification to VDD for evaluation. Once a notification form is submitted, VDD reviews the provided information to ensure the product is compliant and safe for animal use. In the VHP notification, applicants must disclose both medicinal and non-medicinal ingredients, their potency, and provide product-related information such as directions for use, intended benefits, and applicable caution statements.
A list of acceptable medicinal ingredients is published on Health Canada’s website under the List of Permitted Substances. This list outlines acceptable ingredient specifications, approved species for ingredient use, and specific cautions. This information must be considered before submitting an application.
Additionally, manufacturers, importers, packagers, labelers, and companies storing veterinary health products must comply with Part 3 of the Good Manufacturing Practices (GMP). This includes adherence to regulations concerning premises, equipment, personnel, sanitation programs, general operations, quality assurance, stability periods, and record-keeping.
VHP Notification Overview
To notify Health Canada about your veterinary health product, several preparation steps are required:
- Create an Account with Health Canada for Veterinary Health Product (VHP) Submissions. All applicants must create an account for their business to submit their notifications for review. This will allow Health Canada to contact and support the applicants directly throughout the notification process.
- Prepare the Notification Form for Your Veterinary Health Product (VHP). Once an account has been created, applicants can start a new Notification Form. The form must be filled out and provide product-related information, including the product’s brand name, type, intended species, dosage form, active ingredients, recommended use or purpose, recommended dose, duration of use, package size, expiry or shelf life, cautions and contraindications, and warnings.
It is important to note that only ingredients listed in the List of Permitted Substances can be included in the product and listed on the notification form. If an ingredient of interest is not listed, applicants can submit a Short Substance Application for the ingredient in question for Health Canada’s safety evaluation. This review must be completed, and the ingredient must be approved for use in the identified species before the notification form can be submitted.
If a Short Substance Application for a new ingredient is rejected, a Long Substance Application must be submitted instead. A Long Substance Application requires additional information about the ingredient, such as scientific research articles, to support its efficacy and safety for the intended species. The evidence should demonstrate how the ingredient promotes or maintains general animal health for the suggested route of administration. The submitted evidence is reviewed, and a final decision regarding its addition to the List of Permitted Substances is made.
- Submit the Notification Form to Health Canada. Once the ingredients are added to the List of Permitted Substances and the Notification Form is completed, applicants can submit their application to Health Canada for review. During this review, Health Canada will ensure that the information provided is accurate and that the proposed product formula is safe and effective for use in the animal species indicated on the application. The review process is subject to a performance standard of 30 days, which consists of two stages: Admin Screening and Information Verification.
- Admin Screening: During this stage, Health Canada ensures that the application is properly filled out. This includes checking that the Notification Form is complete, and that all necessary information is included. The performance standard for this stage is 10 days. During this stage, the application may be rejected for incompletion (form deficiencies) or for not meeting the application criteria (product does not meet the definition of veterinary health products).
- Information Verification: In this stage, Health Canada reviews the product information to ensure that the notified veterinary health products are safe for use in the intended species and that no additional information is required to support the product’s safety. The performance standard for this stage is 10-20 days.
- Admin Request for Additional Information. If additional product information is required during the Information Verification stage, Health Canada will issue an Admin Request. This request will grant the applicant 7 calendar days to provide the missing information. If the response is deficient or if the deadline is not met, the application will be rejected.
- Accepted Notification. If the application provides the necessary information in full and no additional information is required, Health Canada will accept the notification and issue a Notification Number (NN) for the product. This number will be added to an online List of Notified Products, which will include core information about the product and the notifier (business information).
Change to already Notified VHPs
To modify or update veterinary health products that are already notified, notifiers need to amend the previously submitted notification, providing new information for further review.
This process involves accessing the notifier’s account and selecting the “modify” option from the drop-down menu of the notified product. This enables notifiers to adjust the current product information and resubmit it for additional assessment.
Similar to new notifications, any changes made to products will undergo review following the same process pathway outlined above.
Notifications to update already notified products must be submitted at minimum 30 days prior to implementation. Changes outside of the regulatory scope require additional time considerations and submissions for ingredients not already included on the approved list.
VHP Labelling Requirements
Veterinary health products (VHPs) must comply with the labelling regulations outlined in the Food and Drugs Act and Regulations prior to product’s sale in Canada. The information presented on the product label must be identical to the information listed in the approved notification and the online database. Products must remain within the scope of approved product claims and ensure that the product is represented in a truthful and non-misleading manner.
Labelling requirements include compliance with language, legibility, readability, content, and location rules. VHP labels must also include the following:
- Name and address of notifier (manufacturer)
- Lot number
- Expiry date and self life
- Adequate directions of use, including suggested use, intended species, recommended dose, route of administration, duration of use, warnings, cautions, and storage information
- List of active ingredients and their quantity per dosage unit
- List of excipient ingredients
- Net amount in the container
- Contact information for questions and to reporter side effects
Lastly, core product information required by the regulations must appear in both official languages, English and French. Information presented in French must be equally legible and compliant with the regulations.
VHP Notification Fees
Starting from April 1st, 2020, all notifications for VHPs are accompanied by a submission fee. This fee applies to submissions that modify previously notified products, resulting in the issuance of a new Notification Number (NN) due to the introduced changes. Find detailed information about the VHP fees in our post linked here: Health Canada’s Veterinary Health Product (VHP) Licensing Fees. More about the licensing fees here.
Key Points to Remember
The process of notifying veterinary health products (VHPs) demands thorough planning and consideration of time to ensure full adherence to labelling, composition, safety, efficacy, and quality standards. Manufacturers of VHPs must verify that their product ingredients are listed on the List of Approved Ingredients. Ingredients not yet approved for use in VHPs require additional steps for evaluation and approval, which may involve conducting studies to establish their safety and efficacy for the intended species.
Following a successful product notification, manufacturers bear the responsibility of ensuring that their product labelling and marketing practices comply with applicable regulations. Product information must meet specified technical criteria and remain consistent with the details provided during notification.
While Health Canada stipulates requires a 30-day timeframe for new product notifications, manufacturers should be prepared for the possibility that the preparation phase might extend the notification process to anywhere from 2 to 5 months.
Dell Tech’s Support with Veterinary Health Products
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