Do I Need a License to Import?

We are often asked whether or not a license is required for health products that are planned for import into Canada.
 
Health Canada has an easy-to-follow policy on the importation of prescription drugs, over-the-counter drugs and natural health products (dietary supplements). The Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0084) outlines the requirements related to the importation of health products as defined by the Food and Drugs Act. Although the policy is several years old it can still be consulted for information and guidance as to which products will be allowed into the country, and which will be held up at the border.
 
Health Canada divides importation of health products into two distinct categories: personal use importations and commercial importations. Understanding the difference between these will enable you to have a basic appreciation for why your products are being refused at the Canadian border rather than reaching your consumers.
 
Personal use importations may be exempt from some of the licensing obligations that commercial importations face, but the catch is that the shipments must meet the definition of personal use importations, as well as meet certain criteria:
 
Personal Use Importation: applies to products imported by an individual for their own use, or for a personal under that individual’s care or guardianship, and not for further sale.
 
In order to be eligible as a personal use importation, health products should consist of the lesser of: a single course of treatment or a 90-day supply based on the directions for use.
 
Packaging for personal use importation products must be as per:
• the hospital or pharmacy dispensed packaging;
• the original retail packaging; or have the original label attached which clearly indicates what the health product contains.
 
If none of the above criteria matches your product shipment, your products are most likely to be regarded as commercial importations, and therefore subject to a more rigorous set of regulations:
 
Health Canada considers that commercial importation shipments as those where:
1. the shipment is destined for a retailer, distributor, or other commercial establishment,
2. the shipment originates from a single foreign supplier consisting of individually addressed parcels,
3. the shipment contains more than a 90-day supply of a drug or NHP, based on its directions for use,
4. the shipment is accompanied by materials to be used for advertising or promotion,
5. the shipment is destined for export.
 
Health products commercially imported into Canada must meet all applicable requirements of the Food and Drugs Act and its Regulations including proper labelling, market authorization and establishment licenses. Here’s a summary of the different licensing requirements for over-the-counter drugs and natural health products that are intended to be shipped to Canada for commercial purposes.
 
License Requirements for Natural Health Products (dietary supplements):
• Product license (NPN or DIN-HM) for each product.
• Site license for each importer located in Canada.
• The foreign manufacturer must be listed on the importer’s site license.
 
License Requirements for Over-the-Counter and Prescription Drugs
• Product license (DIN) for each product.
• Importers must hold a drug establishment license.
• The foreign manufacturer must be listed on the importer’s drug establishment license.