5.0 Commercial Importation
All health products commercially imported into Canada must meet all applicable requirements of the Food and Drugs Act and its Regulations, including, but not limited to:
Labelling
Marketing authorization requirements and Establishment Licence, Site Licence or Establishment Registration requirements; or authorization to conduct a clinical trail; and
GMP requirements
Health Canada considers that commercial importation activities include, but are not limited to, the following importations:
A shipment destined for a retailer, distributor, or other commercial establishment. This would include shipments being sent to independent sales contractors/distributors, or to a practitioner for use in their practice.
A shipment from a single foreign supplier consisting of individually addressed parcels, and the importer of record as indicated on a separate invoice for each parcel is not unique for each parcel.
A shipment that contains more than a 90-day supply of a drug, based on its directions for use or reasonable intake.
A shipment that is part of a pattern of repeat personal importations of the same drug to the same individual at the same address within a 90-day period and the total quantity imported in all shipments totals more than a 90 day supply based on its directions for use or reasonable intake.
A shipment that is accompanied by or associated with materials to be used for advertising or promotion.
A shipment destined for export.
A shipment of health product destined to a practitioner or qualified investigator of a clinical trial that is to be given to or used to treat a patient or a subject in a clinical trial. In the case of an animal practitioner this includes importation and administration to animals they do not own.