Companies seeking to import Natural Health Products (NHPs) into Canada do not necessarily need to obtain their own Site Licence. Under Canada’s Natural Health Products Regulations, commercial importation must be conducted by an appropriately licensed Canadian importer, but foreign manufacturers, brand owners and other businesses may use an existing Site Licence holder rather than establish their own licensed import operation.
This distinction provides an alternative for companies seeking access to the Canadian market without establishing the infrastructure necessary to maintain an NHP Site Licence and associated Good Manufacturing Practices (GMP) compliance systems. However, importing through another company’s Site Licence does not eliminate applicable requirements for product authorization, foreign-site GMP compliance, quality assurance, documentation and product release.
Health Canada’s updated Good Manufacturing Practices Guide for Natural Health Products (GUI-0158), Version 4, implemented on March 4, 2026, provides further clarification regarding GMP expectations, including the oversight and quality controls required of Canadian importers.
For businesses evaluating their Canadian market entry strategy, the distinction between obtaining a Site Licence and using an established licensed importer can affect operational responsibilities, regulatory resources and ongoing compliance obligations. Understanding how these arrangements work is therefore an important consideration before commercial importation begins.
Part 2 of the Natural Health Products Regulations establishes the Site Licensing requirements applicable to Canadian establishments that manufacture, package, label or import NHPs for sale. Under Section 27, these activities cannot be performed without an appropriate Site Licence authorizing the regulated activity.
However, the requirement to hold a Site Licence does not automatically extend to every organization involved in owning, marketing or distributing an NHP. A foreign manufacturer or brand owner that does not independently perform regulated activities in Canada may instead arrange for its products to be imported through an existing Canadian Site Licence holder authorized for importation.
For example, a U.S. dietary supplement manufacturer seeking to sell its products in Canada may already maintain established manufacturing operations, product specifications and quality systems outside Canada. Rather than establishing its own Canadian import operation, the manufacturer may engage an appropriately licensed Canadian importer to perform the regulated importation activities and associated quality assurance functions.
This arrangement is particularly relevant to international manufacturers, brand owners and Canadian companies that do not intend to establish their own licensed import infrastructure. Although the licensed importer assumes the regulatory obligations applicable to its activities, the products must still meet Canadian market authorization and GMP requirements.
An NHP product licence and a Site Licence address different regulatory requirements, and both must be considered when establishing a compliant importation strategy. A product licence authorizes the sale of a specific NHP, while a Site Licence authorizes regulated activities performed at Canadian establishments.
Under Part 1 of the Natural Health Products Regulations, NHPs generally require a product licence before being legally sold in Canada. Following Health Canada’s assessment of the product’s safety, efficacy and quality, authorized products receive an eight-digit Natural Product Number (NPN), while licensed homeopathic medicines receive a Homeopathic Medicine Number (DIN-HM).
A product licence does not independently authorize importation, just as a Site Licence does not authorize the commercial sale of products lacking the required Canadian product authorization. Consequently, a company may hold the NPN for its products while relying on a separate Canadian Site Licence holder to conduct the regulated importation activities.
For example, a foreign manufacturer may be the product licence holder for an NHP marketed in Canada, while a Canadian importer manages importation, quality assurance and product release. The responsibilities of the product licence holder and importer must be appropriately addressed, particularly where different organizations manage product authorization, foreign manufacturing, distribution and post-market activities.
Companies can confirm whether an NHP has been authorized for sale through Health Canada’s Licensed Natural Health Products Database.
Using an established Site Licence holder allows businesses to separate product ownership and commercial operations from the regulated activities associated with importing NHPs into Canada. The licensed importer performs the authorized importation activities and maintains the quality systems necessary to demonstrate compliance with the applicable Canadian requirements.
Before importation begins, the parties must confirm that the product has the required Canadian product licence, that the relevant foreign manufacturing, packaging and labelling sites and their activities are listed on the Canadian importer’s Site Licence, and that the importer has access to the documentation necessary to assess product quality and support release for sale. Adding a foreign site to the importer’s Site Licence requires acceptable supporting GMP evidence. For example, a foreign manufacturer may continue manufacturing, packaging and testing its NHPs at an overseas facility while a Canadian Site Licence holder performs importer oversight, evaluates relevant quality documentation and manages the required product release process. Depending on the arrangement, storage, distribution, fulfillment and customs brokerage may be coordinated through additional service providers.
Although individual activities can be performed by different organizations, the allocation of responsibilities should be clearly established through appropriate quality agreements, procedures and supporting documentation. The licensed Canadian importer remains responsible for meeting the regulatory requirements applicable to its importation activities, including maintaining appropriate oversight of work performed by third parties.
Companies evaluating this model can review dicentra’s NHP Importation Services, which provide access to an established Canadian Site Licence holder alongside regulatory and quality assurance support.
Importing NHPs through an existing Site Licence does not eliminate the regulatory responsibilities associated with the products. Part 3 of the Natural Health Products Regulations establishes GMP requirements governing the manufacture, packaging, labelling, importation, distribution and storage of NHPs sold in Canada.
Health Canada’s updated Good Manufacturing Practices Guide for Natural Health Products (GUI-0158), Version 4 came into effect on March 4, 2026, providing additional clarification regarding the implementation of GMP requirements. For importers, these requirements extend beyond confirming that a foreign manufacturer operates under an appropriate quality system.
The importer must have appropriate processes to assess imported products against their established specifications, maintain oversight of relevant foreign activities and ensure that the required quality information is available before products are released for sale. Depending on the product and supply chain, these responsibilities can involve testing, Certificates of Analysis, stability, quality agreements, complaints, investigations, documentation and recall procedures.
Foreign-Site GMP Compliance
NHPs manufactured, packaged or labelled outside Canada must meet the applicable Canadian GMP requirements, even though foreign establishments do not obtain Canadian NHP Site Licences in the same manner as Canadian sites. The Canadian importer must provide acceptable evidence supporting the GMP compliance of the relevant foreign activities through the Site Licensing framework.
Depending on the circumstances, evidence may include inspection reports, Quality Assurance Reports or other documentation acceptable to Health Canada. The Foreign Site Reference Number (FSRN) process was discontinued on February 16, 2026. Foreign-site GMP evidence must now be submitted through the Canadian importer’s site licensing application process. The importer remains responsible for ensuring that the foreign activities associated with its imported products meet the applicable requirements, regardless of whether manufacturing or testing is performed by an established overseas supplier.
Quality Assurance and Product Release
Quality assurance is a central component of the importer’s regulatory responsibilities. Under Section 51 of the Natural Health Products Regulations, importers must have a qualified Quality Assurance Person (QAP) responsible for assuring product quality before sale. Every lot or batch must be approved by a QAP before it is made available for sale. For imported NHPs, this assessment can involve finished-product specifications, testing results, Certificates of Analysis, batch documentation and other information supporting the product’s identity, purity, quantity, potency and overall quality.
Although testing may be performed by a foreign manufacturer or third-party laboratory, the Canadian importer must maintain appropriate oversight and access to the information necessary to support its quality decisions. Importation does not automatically authorize commercial distribution, and products must undergo the applicable quality review and release procedures before being made available for sale.
Stability, Records and Recall Procedures
Imported NHPs must also be supported by appropriate stability information demonstrating that the products maintain their required quality characteristics throughout their assigned shelf life. Where stability studies are performed by foreign manufacturers, the Canadian importer still requires access to the information necessary to support the Canadian product’s expiry date.
Documentation must also provide evidence that applicable GMP activities have been performed. Depending on the operation, this may include specifications, Certificates of Analysis, release records, quality agreements, manufacturing information, stability documentation, complaints, investigations, corrective and preventive actions and distribution records.
Importers must also maintain appropriate traceability and recall procedures, allowing affected products to be identified and addressed when quality issues arise. These systems are particularly important where imported products pass through multiple manufacturers, warehouses, distributors or other parties before reaching Canadian consumers.
For further information on how these requirements are assessed during regulatory oversight, see dicentra’s companion article, NHP GMP Inspections: What Importers Need to Demonstrate.
Commercial NHP shipments must be supported by sufficient information to demonstrate that the products and importation arrangements comply with applicable Canadian requirements. Health Canada works with the Canada Border Services Agency (CBSA) to assess the admissibility of regulated health products entering Canada.
Depending on the shipment, relevant information may include the product’s NPN or DIN-HM, Canadian-authorized labelling, commercial invoices, identification of the licensed Canadian importer and documentation supporting the applicable product and Site Licensing requirements.
The importer must also maintain appropriate quality documentation beyond the information accompanying the shipment. Product specifications, Certificates of Analysis, testing records, stability evidence and other supporting information may be necessary to demonstrate that imported products meet the applicable requirements before release for sale.
For example, a shipment may arrive with complete customs documentation but still require additional quality review before commercial distribution. Conversely, products manufactured under an established foreign quality system may encounter border admissibility concerns if the required Canadian authorization or importer information cannot be demonstrated.
Where authorities cannot determine that a shipment meets applicable requirements, additional information may be requested, and non-compliant products may be detained or refused entry. Coordinating regulatory, quality and customs documentation before shipment can therefore help reduce avoidable importation delays.
Obtaining Your Own Site Licence vs. Using an Established Importer
The decision to obtain an NHP Site Licence or work with an existing licensed importer depends on the company’s intended Canadian operations, regulatory resources and long-term commercial requirements. Both approaches can support compliant market entry, but they involve different operational responsibilities.
Companies establishing their own licensed import operations must develop and maintain the infrastructure necessary to comply with applicable Site Licensing and GMP requirements. This includes appropriate personnel, quality assurance systems, documented procedures, foreign-site oversight, product release controls and the records necessary to demonstrate ongoing compliance.
By comparison, companies using an established Site Licence holder can rely on that organization’s authorized importation activities and associated quality infrastructure, provided the importer accepts the products and the parties establish appropriate regulatory and quality responsibilities.
For example, a manufacturer entering Canada with a limited product portfolio may prefer to use an existing importer rather than establish a separate Canadian quality operation. A company planning substantial ongoing importation activities may instead determine that maintaining its own licensed infrastructure better supports its operational requirements.
Neither approach eliminates the need for product authorization or GMP compliance. The distinction concerns which organization performs the regulated importation activities and maintains the systems necessary to demonstrate that those activities comply with Canadian requirements.
dicentra’s Natural Health Product GMP Training provides practical instruction on Canada’s GMP requirements, based on Health Canada’s latest Good Manufacturing Practices Guide for Natural Health Products (GUI-0158).
Designed for current and prospective Site Licence holders, Quality Assurance Persons (QAPs) and personnel involved in NHP operations, the online course covers the broader GMP framework, with particular relevance to importation activities such as foreign-site GMP oversight, product specifications, testing documentation, quality agreements and product release. Participants who successfully complete the training and assessment receive a certificate with a unique serial ID that can be maintained as part of their organization’s training records.
Companies seeking to enter the Canadian NHP market do not necessarily need to establish their own licensed importation operations. Through its NHP Importation Services, dicentra can act as the licensed Canadian importer for eligible products, providing the regulatory and quality assurance oversight required to support compliant market entry.
As an established Canadian Site Licence holder, dicentra supports foreign-site GMP assessments, finished-product documentation and testing review, quality agreements, QAP oversight and product release. GMP-compliant warehousing, fulfillment and customs brokerage support are also available through an affiliated third-party logistics provider.
For companies pursuing their own Site Licence, dicentra also provides regulatory consulting to support licence applications, quality system development, GMP documentation and inspection readiness.
Explore dicentra’s NHP Importation Services to learn how eligible products can be imported through an established Canadian Site Licence holder.