Import and Export Compliance Basics for Pharmaceuticals in Canada
The licences, exceptions and documents behind lawful pharmaceutical import and export in Canada: DEL activities, SAP, exceptional importation, Division 5, GDP transport and controlled substances.
Who may import a drug into Canada
Importing a drug for sale is a licensable activity. The importer must hold a Drug Establishment Licence (DEL) that lists import as an activity, and the foreign site that fabricated the drug must appear on that licence as an approved foreign building [1]. A pharmacy or hospital that is not a DEL holder cannot import commercial stock itself; it buys from a licensed importer.
The exceptions that matter for patient care
- Special Access Programme (SAP): Health Canada may authorize the sale of a drug not authorized in Canada to a practitioner for a specific patient. The drug is imported against the SAP letter of authorization [2].
- Exceptional importation during shortages: Health Canada can add a foreign product to its exceptional importation list; only the products and importers named may use it, for the period stated [3].
- Clinical trials: drugs for an authorized trial are imported under Division 5 by the sponsor or its designated importer [4].
Exporting from Canada
A DEL holder may export drugs it is licensed to distribute. The importer of record in the destination country must hold whatever that regulator requires — for example a UK wholesale dealer's licence for unlicensed "specials" imports, or an EU wholesale distribution authorisation. Nexara Health's [import route pages](/import) summarise the destination-side requirement for each country and molecule we have data for.
Documents that travel with every shipment
Certificate of Analysis; batch and expiry; the Canadian DIN record or the SAP/exceptional-importation authorization; a temperature record for cold-chain goods; and a commercial invoice matching the licence holder names. Health Canada's GUI-0069 sets the expectations for temperature control during transport [5].
Controlled substances
Narcotics and controlled drugs require a separate licence under the Controlled Drugs and Substances Act and per-shipment import/export permits from Health Canada's Office of Controlled Substances; a DEL alone is not sufficient [6].
Sources
[1] Health Canada, Drug Establishment Licences — https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences.html
[2] Health Canada, Special Access Program for drugs — https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
[3] Health Canada, exceptional importation and sale of drugs — https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-shortages/exceptional-importation-sale.html
[4] Food and Drug Regulations, Division 5 — https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/page-125.html
[5] Health Canada, GUI-0069 — https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/guidelines-temperature-control-drug-products-storage-transportation-0069.html
[6] Health Canada, Controlled substances licences and permits — https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/licences-permits.html