For an NHP intended for commercial sale in Canada, the product must have the applicable Canadian product licence before marketing. Licensed Natural Health Products are assigned an eight-digit Natural Product Number (NPN), while licensed homeopathic medicines receive a DIN-HM. The applicable market authorization information should also be available as part of the shipment documentation used to demonstrate compliance at import.

Yes. Importation for sale is one of the regulated activities that requires a Canadian Natural Health Product Site Licence. The importer must hold a Site Licence that covers the activity of import. Companies that do not want to establish their own licensed Canadian import operation may be able to work with an appropriately licensed third-party importer such as dicentra.

Yes, but the Canadian regulatory and quality infrastructure must be addressed. The product requires the applicable Canadian product licence, and commercial importation must occur through an appropriately licensed Canadian importer. Applicable foreign manufacturing, packaging and labelling activities must also be supported by acceptable GMP evidence through the Canadian Site Licensing framework.

Yes, for eligible products and supply arrangements. dicentra holds its own Site Licence for importing Natural Health Products into Canada and can provide importer and Quality Assurance functions as an alternative to a company establishing its own Canadian import operation. The specific product, foreign sites, documentation and supply chain should be reviewed before importation begins.

Potentially, yes. A company does not necessarily need to establish its own Site Licence if its products are imported through an appropriately licensed Canadian importer. dicentra can act as the importer for eligible Natural Health Products under its Site Licence while supporting the associated quality and product-release responsibilities.

The Canadian importer holds the Site Licence for the activity of import. Foreign sites performing relevant manufacturing, packaging or labelling activities must be appropriately addressed through the importer’s Canadian Site Licensing and GMP framework. The importer requires acceptable evidence supporting the GMP status of the applicable foreign activities and appropriate oversight of the foreign parties involved.

Importer GMP responsibilities can extend across finished-product specifications and testing, Certificates of Analysis, product release, foreign manufacturing documentation, Quality Assurance Person responsibilities, stability and expiry-date support, transportation and storage, deviations and out-of-specification results, complaints, investigations, CAPAs, recordkeeping, traceability and recall procedures. The exact controls depend on the product, supply chain, contractual arrangements and activities performed by third parties.

Product release is a Quality Assurance responsibility. The Quality Assurance Person plays an important role in determining whether each applicable imported lot meets the established finished-product specifications and Canadian regulatory requirements before release. The assessment can involve test results, Certificates of Analysis, batch documentation and other information relevant to the product’s identity, purity, quantity, potency and overall quality.

Commercial shipments should be supported by enough information for Canadian authorities to assess compliance and admissibility. Depending on the shipment, this can include Canadian-authorized labelling showing the applicable NPN or DIN-HM, invoices and customs documents identifying authorized or licensed suppliers and importers, and references or copies of applicable Health Canada licence information. Importers should work with their brokers and couriers so the necessary information is available at the time of import.

Using a foreign manufacturer does not remove the Canadian importer’s responsibilities. The importer needs appropriate processes for oversight and access to the information required to demonstrate that imported products meet Canadian requirements. This can include foreign manufacturing documentation, quality agreements, specifications, testing information, stability data, investigation records and other quality information needed to support release and ongoing compliance.

Yes. An NHP GMP inspection can examine the systems, procedures, records and activities used to demonstrate compliance with Part 3 of the Natural Health Products Regulations. For importers, this can include product release, Quality Assurance responsibilities, personnel training, specifications, testing, stability, records, foreign-site oversight, written procedures, complaints, investigations, traceability and recall systems.

Health Canada works with the Canada Border Services Agency to assess referred health products at the border. If authorities cannot determine that a shipment meets applicable requirements, the shipment may be detained while additional information is requested. Health products determined to be non-compliant may be refused entry or seized. Complete, accurate shipment documentation can help authorities make a timely admissibility determination.

The records required depend on the product and operation, but importer documentation can include finished-product specifications, Certificates of Analysis, manufacturing information, product-release records, stability documentation, SOPs, quality agreements, complaints, investigations, CAPA records, distribution information and training records. Where records are maintained by a foreign or third-party operation, applicable information still needs to remain accessible as required.

The importer needs appropriate information supporting the Canadian product’s assigned shelf life and expiry date. Stability studies may have been performed by the foreign manufacturer, but the Canadian importer still requires access to the information needed to evaluate whether the available stability program appropriately supports the product throughout its stated shelf life under the recommended storage conditions.

Importation and release are distinct quality and regulatory steps. Bringing a product into Canada does not by itself establish that the lot is suitable for commercial distribution. The importer’s quality system must address the applicable review and release controls needed to determine that the product meets its specifications and Canadian requirements before release for sale.

Yes. Importation support does not have to begin with dicentra acting as the importer. Depending on the need, dicentra can support related regulatory and quality activities such as NHP product licensing, Site Licensing, GMP implementation, foreign-site review, specifications, quality systems, SOPs, supplier qualification, product-release processes and inspection readiness.

dicentra is affiliated with a third-party logistics company annexed to its Site Licence that can provide storage, logistics and fulfillment, and customs brokerage services. These capabilities can be combined with dicentra’s regulatory importation and Quality Assurance services to support the movement and release of eligible NHPs in Canada.