If you work in the pharmaceuticals importation sector, you may have noticed that your shipments are being held at the border increasingly often. Indeed, pharmaceuticals importation is extremely tightly regulated by Health Canada and strictly enforced by the Canadian Border Service Agency (CBSA) – and they have been getting ever more stringent in the wake of disasters such as the 2008 Chinese milk scandal. Here are some things you need to keep in mind when importing pharmaceutical products to Canada to avoid a disastrous compliance mistake.

Pharmaceutical importation for commercial use

There are multiple steps to be taken before you can start importing a pharmaceutical product to Canada. First, you need to obtain a site license, which requires “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 in place. More information on obtaining this license may be found on Health Canada’s website. It is important to keep in mind that every actor involved in the importation process must be licensed – from the airline carrying the pharmaceuticals to all the warehouses where the products are stored along the way.

You also need to obtain a Drug Identification Number (DIN) for any new pharmaceutical product you start importing. Every pharmaceutical product allowed by Health Canada to be imported into the country has such a number. Obtaining a DIN is a lengthy process which requires carrying out in-depth clinical trials with the goal of ensuring the product in question is not harmful to humans.

You also need to respect all the current regulations about packaging and labeling. During the shipping process itself, highly regulated substances, such as narcotics, may require specific forms to fill in addition to the regular customs declaration.

Natural health products (NHPs) such as vitamins, herbal remedies and homeopathic medicine are not exempt from these regulations – Health Canada treats them similarly to over-the-counter drugs and they require a site license and a Natural Product Number (NPN) for importation.

Commercial importation of pharmaceuticals is not a business where you can “start small”, nor is it something you can do part-time with the purpose of turning up a quick profit: getting all these steps right can take years, and the costs for the procedures can be very high. Still, pharmaceutical importation is a lucrative sector, and W2C will be glad to provide you with the consulting services you need.

Importing cosmetics

Even though importing cosmetics is still significantly easier than importing pharmaceuticals, it’s harder than it used to be just a few years ago. Though they don’t require site licenses or DIN numbers, the customs now thoroughly check all incoming cosmetics, and reject any that are either “adulterated” or “misbranded”.

A cosmetic is considered adulterated if it contains ingredients that may be harmful to the user according to Health Canada’s regulations, is composed of putrid or decomposed substances, or has been contaminated with filth. It is considered misbranded if the packaging lacks required information, improperly labels the cosmetic product’s ingredients, or makes any other false or misleading claims.

It should also be noted that the line between a drug and a cosmetic can be quite thin. For example, a toothpaste that whitens teeth is considered a cosmetic, but a toothpaste which, according to its packaging, “fights cavities” is considered a pharmaceutical product and as such requires a site license and a DIN number. The same goes for a shampoo that “fights dandruff”.

Pharmaceutical importation for personal use

To end on a different note, if you are a visitor to Canada, you should know that you can bring a supply for up to 90 days (or a single course of treatment) of most common prescription drugs. Obviously, a chronic condition which requires pharmaceutical support should not be an obstacle to prevent tourists from coming to Canada.

If you are importing drugs for your personal use while living in Canada, things get slightly more complicated. On the one hand, the importation of prescription drugs for human use is extremely highly regulated by Health Canada, and therefore, importing such drugs by mail or courier is not permitted for Canadian residents. On the other hand, you can import over-the-counter drugs for your personal use (again, a single course of treatment or a 90-day supply) provided these drugs contain no ingredients found in the Prescription Drug List.

In conclusion…

When it comes to importing drugs to Canada, acquiring the relevant licenses and permits is far from the end of the line: it is crucial to maintain a history of compliance with Health Canada’s guidelines. A single mistake is all it can take to be stripped of the right to import pharmaceuticals to Canada. Here at W2C, it is our mission to advise you on the current regulations and help you maintain compliance to avoid any complications throughout the importation process.