The market for animal and pet products is growing at a rapid pace. With that, there is also a constant need for compliance, with many Veterinary Health Products being rushed to market. This blog will aim to steer you toward compliance with your Veterinary Health Products (VHPs) or Animal Supplements in Canada. We will highlight key points on how to register, import, and sell your VHP products in Canada.
Registering your Veterinary Health Products in Canada:
Previously, the VHP notification program was voluntary, but as of November 2017, the new formal notification program was put in place. It is important to first classify the product properly as a VHP, as veterinary drugs and animal feed products are not regulated under the VHP framework.
This is to be done by examining the dosage form, the proposed use, or claims being made and ensuring all ingredients are properly listed in the Permitted Substance List (PSL), amongst other criteria. Any ingredients that are not present or do not reflect the purpose as used in your product, within the PSL, can be added or amended via a PSL Notification. This must be done before filing the VHP notification.
It is required for a company that is located outside of Canada to arrange and provide the contact information for a Canadian Representative. QSS can act as your Canadian representative for VHP applications and throughout the product lifecycle. It is also required that a company located outside of Canada lists the importer or product receiver on the notification form.
The Notification Form is completed online on the Health Canada portal and is submitted there as well. Companies are required to notify their VHPs to Health Canada: At least 30 days before selling a VHP in Canada, at least 30 days before making a change to a VHP that is already notified in Canada, and before importing a VHP into Canada. We recommend waiting for approval before finalizing the label or going to market.
There are fees payable to Health Canada associated with the notification. The current fee is $503 (subject to an annual increase). Please know that your company may qualify for a reduction or fee waiver based on the first application or company size.
The current standard Health Canada timeline for review of ingredient and product notifications is ~2 months, based on recent submissions.
During the review, Health Canada will review your VHP claims and ingredients. They may ask for revisions to ensure the product is safe, efficacious, and of high quality for the Canadian market. After their review, they will issue a licensing decision and if approved, issue a Notification Number (NN).
VHP Selling in Canada:
The product owner or notifier must ensure the product is properly labeled. This includes bilingual label text, adding the NN to the label, and calling out ‘Veterinary Health Product’ on the front panel, amongst other requirements. It is important that your product is not labeled in a way that is misleading or false. The best way to avoid this is to only use verbiage that is approved within your notification.
Also, while on market, it is required that companies report any serious adverse drug reactions to Health Canada.
Furthermore, should you wish to make a post-notification change to your product, you would need to determine whether the change requires a new NN or if a revision can be made to the existing NN.
VHP Importing (CFIA Requirements):
All animal products and tissues being imported must be notified and adhere to CFIA import requirements. This can be confirmed, researched, and verified on the AIRS webpage for animal/commodity-specific requirements. You may require documentation such as veterinary health product certificates or import permits for specific materials/ingredients.
All commercial shipments must be handled properly to ensure all duties and taxes are paid to Canada Revenue Agency (CRA) and/or Canada Border Services Agency (CBSA). This can be handled through a customs broker.
The product owner must ensure the import documentation shows the VHP Notification Number. The sites/contacts that are involved in processing, importing, and storing your products as per your VHP application. The Canadian Representative should also be listed here. You should be prepared to answer questions from the CBSA at the time of import.
It is important to ensure compliance during the whole product lifecycle to reduce enforcement action from any regulatory body. Working with a regulatory consultant such as Quality Smart Solutions can help get your product notified, labeled, and launched into the Canadian Market. We can also consult Health Canada on your behalf for any unique questions you may have.
Please reach out to our team of specialists for any questions regarding your VHPs in Canada. Such as ingredient and formula review, Canadian representative solutions, notification submission, labeling, bilingual translation, and post-licensing changes. We are happy to help!