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Shipping medicine to Canada can often be a frustratingly complicated process, and even small mistakes can lead to huge delays. The regulations for shipping medicine into Canada have been steadily tightening over time. And yet, it can be hard to resist breaking into the lucrative industry. The U.S. pharmaceutical industry generated over USD$55 billion in exports just in 2018 alone!
Shipping medicine to Canada requires importers to follow strict guidelines in order to clear Canadian customs. This means securing a site license, DIN, and label approval from Health Canada, as well as ensuring that all shipments meet the set quality standard.
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Health Canada is the department of government that regulates the import of pharmaceuticals and other health-related products. It is also responsible for ensuring compliance with all health-related laws, and has many other responsibilities besides just regulating medicine and medical devices.
Health Canada is also responsible for:
If you are going to be shipping medicine to Canada, you are going to need to understand the guidelines and regulations set in place by the Health Canada department.
Shipping medicine to Canada can be quite a different process depending on whether you are just an exporter, or if you’re a non-resident importer as well.
If you are a regular exporter, you would only have to worry about the product itself, and getting it to the border. This includes correct labeling, safe transport, and good communication with the importer on when the shipment would be ready for them to pick up. The rest of the process would become the importer’s responsibility.
If you are a non-resident importer, however, you would act like the exporter and the importer of record at the same time. That means that you would be responsible for labeling and transport to the border, but you would also have to manage the customs clearance process and arrange shipping on the Canadian side of the border.
Being a non-resident importer can be a lot of added responsibility, but it can also give you a lot more control over the process. Additionally, by taking up the importing responsibilities, you can offer your customers an easier buying experience. However, if the responsibility is too much to bear, you could still become a non-resident importer anyway with the help of a good third-party logistics company.
Customs clearance can be a difficult process to understand, especially when dealing with a tightly regulated commodity in an unfamiliar country. Even if you understand the basics of shipping into Canada, the strict regulations on medicine make it difficult for companies to get involved. However, with just a little instruction, you could be well on your way to doing business in Canada.
Every single person involved in the process of handling medications must have a valid site license for the location in which the medication will be handled. This includes manufacturers, packagers, labelers, and importers. It is unlawful to handle medications for sale without having a site license.
For medications being imported, the importer of record would need to have a site license to verify that the foreign manufacturer meets the Canadian regulations and quality standards.
Applicants for site licenses will need to include specific information on their application, like:
Information can be filled out in the Site License Application (SLA) Form, and when applicable, the Designated Party Authorization (DPA) Form.
A Drug Identification Number (DIN) is a special code assigned to all prescription and over-the-counter medications in Canada. It is assigned once the medication has been evaluated by Health Canada to be effective and safe for use.
The DIN identifies a number of key features about a specific medication:
When shipping medications to Canada, you will need to ensure that you have the correct DIN for the product. If any of the factors listed above are altered, like if it was a different dosage of the same medicine or if the method of administration was changed from an injectable to pill, then the DIN would no longer apply and it would be treated as a new medicine.
If you are shipping a new medication to Canada that is not already on the market, then the process for approval is far lengthier. Not only would you need to apply for a DIN, but you would also need to include a Notice of Compliance (NOC) in order to make it to the Canadian market. More information on applying for review is available on the Health Canada website.
When labeling medicine for sale in Canada, you will need to ensure that your labels are compliant with all the regulations. Under no circumstances should any label be false, remotely misleading, or deceptive in any way, especially not to give the product a more positive perception among consumers. Failure to follow basic labeling guidelines also constitutes as being misleading.
The principal display should include:
Other labels should include:
Additionally, all labels must be in both French and English.
When shipping natural health products such as vitamins, teas, and other natural remedies, you might assume that the process is easier—but you’d be wrong. Natural health products are treated very similarly to over-the-counter medicine and require a lot of the same attention from importers and customs officers.
The only thing that really differs is that the product will require a Natural Product Number (NPN) instead of a DIN. Otherwise, you can expect to have to go through all the steps you would if you were importing regular over-the-counter medication.
Shipping medicine to Canada doesn’t have to be complicated! With R+L Global Logistics, you can have your freight delivered temperature-controlled and expedited to the border, where our trusted Canadian partners will pick it up to finish the job. You wouldn’t have to worry about anything since our real-time tracking solutions give you complete visibility from start to finish. If you have medicine to ship, or even need baked good shipped, we can get it there quickly, safely, and for the best price, to ensure you get the best value for your money. We work all over the Canadian-U.S. border, including in New York in such cities as Alexandria Bay. Give us a call, or request a quote today!
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