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Having your NPN is only part of the equation. Before a single unit can legally cross the Canadian border, Health Canada requires a licensed, Canadian-based importer of record — legally accountable for every lot that enters the country. Through its sister company Quality Import Solutions (QIS), QSS provides that infrastructure, from site licence annexation through ongoing lot release.
Health Canada's Natural Health Products Regulations require every NHP manufactured outside Canada to have a licensed Canadian importer of record before products can be sold or distributed in the country. A customs broker, freight forwarder, or non-resident importer (NRI) program does not fulfil this requirement. Those are customs clearance mechanisms, not Health Canada compliance designations.
The importer of record also carries legal responsibility for product quality on Canadian soil. That covers GMP compliance, testing standards, label accuracy, and lot-by-lot disposition decisions. Without a qualified partner holding that responsibility, your Canadian distribution is exposed at every shipment.
Your choice of importer also affects your commercial flexibility. If your importer is a distributor, their name appears on your label across every channel. A neutral third-party importer like QIS keeps your retail, direct, and Amazon Canada strategies free of conflict as your Canadian presence grows.
Our sister company QIS holds an NHP Site Licence issued by Health Canada. For your product to be legally imported into Canada, your foreign manufacturing facility — and any Canadian warehouse handling your product — must be annexed to that licence. We manage the full annexation process: reviewing your GMP evidence, preparing the amendment submission to Health Canada, assisting with the Quality Assurance Report where applicable, and responding to any Information Request Notices (IRNs) issued during review. This is the foundational step that makes importation possible.
Once the annexation is approved, QIS acts as your importer of record for a 12-month period. Your products are covered under a valid Health Canada site licence, QIS’s name appears on your label as required, and your importation activity stays in good standing throughout the year. Annual renewal support is part of the ongoing relationship.
Before your first lot ships, QIS reviews the Certificate of Analysis and testing documentation from your foreign manufacturer. We compare that testing against Health Canada’s standards for your specific product and medicinal ingredients, and identify any gaps that need to be addressed before importation commences. This protects the integrity of your product and the validity of your import programme from day one.
Every NHP sold in Canada must carry a bilingual label that meets Health Canada’s requirements for format, claims, and importer identification. QIS reviews your label copy for compliance, creates or refines the text as needed, provides French translation, and delivers up to two proofs assessed for regulatory compliance and marketing claims accuracy. Getting this right before your first shipment avoids delays, relabelling costs, and potential enforcement action.
Every lot exported to Canada must go through a product review and disposition process before it can be released for sale. QIS conducts a physical evaluation, reviews the finished product COA against Health Canada standards, and confirms each lot’s label is consistent with the approved review. This is an ongoing compliance requirement for as long as you are importing into Canada.
Health Canada requirements evolve, and your import programme needs to keep pace. QIS monitors relevant regulatory updates and advises you when changes affect your site licence, label, or lot release process. We work proactively so that renewals, amendments, and new SKUs are handled before they create problems.
A Health Canada importer of record is a Canadian-licensed entity that holds a valid NHP Site Licence and is legally responsible for the quality and compliance of NHPs imported into Canada. Every NHP manufactured outside Canada requires one before products can be sold. A customs broker or non-resident importer program does not fulfil this requirement.
Technically yes, but there are two real complications. First, to legally act as an importer of record, a distributor must hold a valid NHP Site Licence, and most Canadian distributors don’t have one. Second, the importer’s name must appear on your label. If that’s your distributor, you’re tied to their name across all Canadian packaging. Switching distributors later can mean relabelling your entire product line. A neutral third-party importer avoids this entirely.
Yes. The annexation process requires GMP documentation from your manufacturing site. QIS will advise you on exactly what’s needed and guide the information collection process to make it straightforward for your team.
Processing timelines typically range from 5 to 9 months. Preparation quality can influence that timeline. We work to ensure the submission is complete and accurate from the outset to avoid unnecessary delays.
Our sister company QIS will advise on the path forward, which may involve additional testing, label corrections, or holding the lot until compliance is confirmed. No lot is released without meeting Health Canada standards. The COA and manufacturer testing gap assessment we complete before your first shipment is specifically designed to identify and resolve these gaps before they affect your import timeline.
Yes. Your product must hold a valid NPN before importation can begin. That said, the annexation process and testing gap assessment can begin before your NPN is issued, so there is no need to wait to start building your import infrastructure. If you still need one, QSS can support the NPN application process through our NHP Licensing service and transition you into the import programme once the licence is issued.
The site licence requires annual renewal, with the renewal fee due four months before your renewal date to account for Health Canada processing timelines. QIS tracks your renewal schedule and initiates the process proactively.