Health Canada oversees the importation and sale of Veterinary health products (VHPs) in Canada through the VHP Notification Program. This program replaces the previous voluntary Interim Notification Pilot Program (INPP). The VHP Notification Program is a tool that allows manufacturers to notify Health Canada about the sale of their VHPs and changes in their products which may affect their eligibility for marketing as a VHP. In this blog, we’ll also touch upon VHP Registration, VHP package compliance, and VHP Canadian Representative.
1. When does Health Canada need to be notified?
- VHPs must be notified to Health Canada:
- At least 30 days before selling a VHP for the first time in Canada
- At least 30 days before making a change to a VHP that is already notified in Canada
- Before importing a VHP into Canada
- VHP Notifications are submitted to Health Canada’s VHP Customer Service Unit (CSU) in order to process and respond to inquiries, as well as to maintain the accuracy of the information on the Health Canada website.
2. What rules/requirements are needed for the VHP Notification Program?
Companies who manufacture, package, label, import, distribute and/or store VHPs are required to follow Part 3 – Good Manufacturing Practices (GMPs) in the Natural Health Products Regulations.
Product labels must:
- Include the statement “Veterinary Health Product / Produit de santé animale”
- Follow the labelling rules of the Food and Drug Regulations
- Include any applicable mandatory label statements as described in List C
- Companies are required to report any serious adverse drug reactions to Health Canada
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3. What is the process for submitting a VHP Notification?
- Health Canada’s Notification Program (web application) for VHPs provides a user-friendly tool to help notifiers meet the rules for importing and selling VHPs in Canada. After a Notification Form is submitted to Health Canada, received through the VHP Notification Program, and acknowledged, it undergoes an administrative screening stage followed by an info verification stage.
- Notification Forms are screened against all of the required elements of the program. After a positive Admin Screening stage when the required information has been submitted, the Notification Form is considered to be administratively complete and moves to the Info Verification stage. If the Notification Form is administratively incomplete, Health Canada will inform the notifier of all administrative deficiencies via e-mail and ask to resubmit the form with the necessary changes or by providing any missing information via the web application within 10 calendar days. There is a limit of two admin requests per notification at this stage. If the revised form is still deficient or not received within 10 calendar days, it will be rejected, and a new Notification Form will need to be submitted. This type of rejection is referred to as “Rejection (Incomplete Form)”.
- Once a Notification Form is considered to be administratively complete, Health Canada will conduct an assessment of the submitted information to confirm that the VHP is compliant with the applicable rules and regulations. Health Canada will consider the proposed health claim(s), dosing information, and brand name during this stage of the process.
- If the info verification decision is positive, the notifier is informed of the outcome via e-mail, and the issuance of the NN follows. When a VHP is notified, it is added to the List of Notified Products.
- If there are deficiencies identified, the notifier is informed via e-mail and given a maximum of 7 calendar days to resubmit the form using the VHP web application. Health Canada will only issue one info request per notification. If the revised form is not received within 7 days or is deficient, it will be rejected, and a new Notification Form will need to be submitted. This type of rejection is referred to as “Rejection (No Response to Request)” or “Rejection (Deficient Response to Request)”, respectively. Health Canada informs the notifier of this by e-mail.
4. Is there a fee required as part of the VHP Notification Program?
- As of April 1, 2020, VHP notifications are subject to cost recovery. The fee for submitting a VHP notification is $503. Fees will apply to all new VHP notifications received after this date and when changes to an already-notified VHP require the issuance of a new NN.
- An invoice for the applicable fee will be issued by Health Canada once verification is completed for a VHP notification. The notifier (i.e Principal Contact for the Notifier) will receive an invoice by e-mail, along with instructions on how to make payment to the Receiver General for Canada.
- Fees will apply regardless of the outcome of the info verification (positive or negative); therefore, notifiers should ensure that Notification Forms are complete, meet all regulatory requirements and that requests for additional information made by Health Canada are answered completely and within the allotted time.
5. Does Health Canada perform Compliance and Enforcement measures as part of the VHP Notification Program?
- As with all health products (including VHPs), our compliance and enforcement approach is proportional to the risk of the product. VHPs are required to be in compliance with the Food and Drugs Act and Regulations when sold or imported in Canada. Commercial importation requires that VHPs are notified before import. Personal importation (also known as own-use importation) of a VHP for a food-producing animal or animal intended as food that is not notified is only permitted if it is on List B: List of Certain Veterinary Drugs Which May Be Imported But Not Sold.
- When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, it takes steps to verify that non-compliance has occurred. Incidents of non-compliance are prioritized, and action is taken based on the risk they may pose to the general public. Several compliance and enforcement options are available, if necessary, to correct a non-compliant situation or mitigate risk to Canadians including, for example, on-site visits, recalls, public communications, or product seizures. The primary objective of Health Canada’s compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.
