If you work in the pharmaceutical industry and you import prescription drugs, it is not uncommon to have shipments held at the border. Here at BorderBuddy, we hate to see complications like this arise for our customers, so we’d like to provide you some background about Health Canada and CBSA’s regulations that you need to be aware of to help the importation process run smoothly so that this does not happen to you.
The importation and exportation of health products is regulated under the Food and Drugs Act and its associated Regulations includes Human Drugs; Natural Health Products; Medical Devices; Veterinary Drugs; Blood and Blood Components for Transfusion; Human Cells, Tissues and Organs for Transplantation; and Semen for Assisted Conception.
In answering these frequently asked questions about importing pharmaceuticals to Canada we hope to shed some light on exactly what is required for compliance to help you avoid costly mistakes.
1. What kind of license is required for pharmaceutical importation?
First, you need to obtain a site license, which requires that “the physical site in Canada where any persons (business or individual) wish to manufacture, package, label, and/or import” health products to meet all of Health Canada’s requirements regarding safety, sanitation, security measures, and other procedures. More information on site licenses may be found on Health Canada’s website. It is important to keep in mind that every individual involved along the way must be licensed – this includes those flying the planes that carry the drugs, as well as those who run the warehouses where the products are stored.
You also need to obtain a Drug Identification Number (DIN) for any new pharmaceutical product you start importing.
2. What purpose does a Drug Identification Number (DIN) serve?
A DIN lets the user know that the product has undergone and passed a review of its formulation, labeling, and instructions for use. A drug product sold in Canada without a DIN is not in compliance with Canadian law.
The DIN is unique and serves as a tool to help in the follow-up of products on the market, recall of products, inspections, and quality monitoring.
3. I want to sell a natural health product in Canada, what do I have to do?
In order to market your products in Canada, the Natural Health Products Regulations first require you to obtain the necessary product and site licenses.
Product Licensing:
Before any natural health product can be sold in Canada, it must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product license application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Further information on this process is available in the Product Licensing Guidance Document.
Site Licensing:
The Natural Health Products Regulations require any Canadian site where natural health products are manufactured, imported, labeled, packaged, distributed, and/or stored to have a site license. Businesses can choose to have a single site license for all their operations (i.e. multiple sites) or an individual license for each site. Site licenses are obtained by demonstrating that the above-mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs.
Further information is available in the Site Licence Guidance Document. All application forms and templates are available on our Web site under the Applications and Submissions section.
There are no costs or fees associated with the submission and review of product and site license applications.
4. What type of information should I submit to demonstrate the Good Manufacturing Practices (GMP) compliance of a foreign drug establishment?
You can refer to the Health Products and Food Branch Inspectorate policy document entitled “Guidance on Evidence to Demonstrate Drug Compliance of Foreign Sites (GUI-0080)”.
5. An On-Site Evaluation was performed for a specific product. Is the On-Site Evaluation Report sufficient to demonstrate GMP compliance of the foreign drug establishment?
No. An On-Site Evaluation (OSE) is a product-specific evaluation of the manufacture of a drug conducted on-site by a Qualified Authority to assess the conformity with the drug submission. An OSE does not cover all the sections of GMP requirements and when submitted alone is not considered sufficient to demonstrate GMP compliance of the foreign drug establishment. For further information, please consult the Health Products and Food Branch Inspectorate policy document “Guidance on Evidence to Demonstrate Drug Compliance of Foreign Sites (GUI-0080)”.
6. If I want to import a drug and then re-export it–what do I have to do?
A drug importer is required to hold an Establishment Licence and meet the GMP requirements. The foreign site must be GMP compliant and be listed on the importer’s Establishment Licence.
If the drug product is being imported from a foreign site and exported back to the same foreign site, which retains ownership of the drug product throughout the process, the establishment is required to hold an Establishment Licence for packaging. The document entitled “Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership (GUI-0067)” should be consulted for further guidance and additional requirements.
If the drug product is being imported from a foreign site and exported to another foreign site, you cannot be exempted from the requirements of the Food and Drugs Act & Regulations, and you cannot use the exemption provided under Section 37. This is considered a commercial importation. All commercial importation of drugs in dosage form must meet all the requirements of the Food and Drug Regulations, including Division 1 “Drugs”, Division 1A “Establishment Licensing”, Division 2 “Good Manufacturing Practices”, and any other applicable requirements depending on the drug product. The site where the imported drug is fabricated must be listed on the importer’s Establishment Licence and its compliance to the GMP requirements must be demonstrated.
7. Are cosmetics considered the same as pharmaceuticals?
No. However, there is a fine line between the two. For example, a toothpaste that claims to whiten teeth is considered to be a cosmetic, while one that “fights cavities” would be considered a pharmaceutical product. If it is a pharmaceutical product it would require a site license and a DIN number. Shampoos that claim to “fight dandruff” fall into this category as well.
8. Can I import drugs for my personal use while living in Canada?
No. Health Canada prohibits the importation of prescription drugs by courier when imported by Canadian residents for personal use.
The importation of prescription drugs for human use is strictly regulated and is only permitted by certain entities. Under Section C.01.045 of the Food and Drug Regulations, the importation of prescription drugs is restricted to a drug manufacturer, a registered pharmacist, a wholesale druggist, a practitioner, or a resident of a foreign country while a visitor in Canada.
Pharmaceutical importation is a very lucrative sector, however, getting a business set up to be compliant with all these regulations can be a bitter pill! You can’t really start small, and if you’re looking to turn a quick profit, you may be disappointed in the sheer length of time it takes to do all the prep paperwork.
Once you have acquired the proper licensure and permits you must keep in mind that it is very important to maintain compliance with Health Canada’s regulations. You wouldn’t want to let one careless mistake cause you to be penalized. This could impact your business and set you back, so always be prepared and make sure you’ve done all the research to avoid mishaps.
Have questions or concerns? Your buddy at the border is here to help. Please call us for customs solutions today.
