Importation - Globyz

Key Requirements for International Brands

Product licensing: secure the applicable Canadian product licence. An NPN identifies a licensed NHP; homeopathic medicines use a DIN-HM.

Canadian importer: select a partner holding an appropriate NHP Site Licence authorizing importation.

Foreign manufacturing compliance: ensure that overseas manufacturing, packaging and labelling sites meet applicable Canadian NHP GMP expectations and are appropriately covered in the importer’s licensing arrangements.

Product labelling: align licence identification, authorized claims, directions and required English/French information with Canadian requirements.

Customs documentation: prepare for applicable CBSA and Health Canada requirements for commercial importation.

Quality and distribution: establish procedures for storage, transportation, traceability, complaints and recalls.

Build a Coordinated Market-Entry Plan

An established international product still needs a Canada-specific plan. Review the formula, claims, licence status, label and supply chain together, and define which organization is responsible for each activity.

Foreign brands should confirm the scope and validity of proposed partners’ authorizations before relying on them for regulated activities.

How Can Globyz Biopharma Help?

Globyz Biopharma supports businesses exploring Canadian NHP market entry by helping them understand regulatory expectations, importation pathways and quality compliance requirements.

Whether you are launching a new product or expanding an established brand, contact Globyz or email info@globyz.com to discuss your regulatory and operational needs.

Canada NHP Market-Entry Series · Part 5 of 6

Importing Natural Health Products into Canada requires compliance with Health Canada’s Natural Health Products Regulations and applicable Canada Border Services Agency (CBSA) requirements.

Businesses must ensure that products are properly licensed, imported through an appropriate importer and handled in accordance with Good Manufacturing Practices.

Key Requirements for Importing NHPs

Product licensing: NHPs for commercial sale require the appropriate product licence, identified by an NPN or DIN-HM.
Importer site licence: the Canadian importer must hold an appropriate NHP Site Licence authorizing importation.
Importer model: businesses may establish their own licensed Canadian importing operation or work with an appropriately licensed third-party importer.
Foreign site compliance: confirm that applicable foreign manufacturing, packaging and labelling sites are covered by the importer’s licensing arrangements and supported by appropriate GMP evidence.
Customs clearance: prepare accurate product descriptions, commercial invoices, tariff classification and applicable import documentation.
Quality assurance: establish responsibilities for specifications, batch documentation, required release procedures, traceability, storage and transportation conditions.
Labelling: meet the applicable Canadian requirements, including licence identification, product information and English/French labelling.

Coordinate Before the First Shipment

Confirm the importer, product authorizations, foreign site evidence and quality responsibilities before arranging commercial shipments. A customs broker can assist with clearance, but customs processing does not replace Health Canada’s product and site licensing requirements.

This overview addresses commercial products for sale. Clinical trial products and other special situations may follow different requirements.

How Can Globyz Biopharma Help?

Globyz Biopharma supports businesses exploring Canadian NHP market entry by helping them understand regulatory expectations, importation pathways and quality compliance requirements.

Whether you are launching a new product or expanding an established brand, contact Globyz or email info@globyz.com to discuss your regulatory and operational needs.