Regional review
Canada
Canadian buyers work with Health Canada, which administers drug establishment licensing and the Food and Drugs Act, together with CEPA and the Domestic Substances List for chemicals and WHMIS for workplace hazard communication. Bilingual labelling requirements apply broadly and are often the first practical obstacle for an imported consignment.
Sourcing considerations
Importers of drugs generally require an establishment licence, and the foreign site must appear on it, which means the buyer needs specific site and entity information from the supplier well before shipment. For chemicals, whether the substance appears on the Domestic Substances List determines the notification path.
Documentation requirements
Buyers typically request a specification, batch COA, and a WHMIS-compliant SDS in English and French. Where a drug is involved, expect requests for site identity information to support establishment licence listing.
Import considerations
Canada Border Services Agency screening is coordinated with Health Canada for regulated goods. Substances not on the Domestic Substances List may require a New Substances Notification before import.
Shipping and transport
Transport follows the Transportation of Dangerous Goods regulations; winter routing and long domestic legs make temperature control relevant for both frozen and ambient-sensitive material.
Questions buyers should ask
- Is the substance on the Domestic Substances List?
- Is the SDS bilingual and WHMIS-compliant?
- Does the importer hold a drug establishment licence naming the foreign site?
- What is the intended use declaration?
- Who is the Canadian importer of record?