Biphasic Isophane Insulin Bulk Mixture
A bulk biphasic mixture of human insulin isophane suspension and soluble insulin, formulated for prolonged therapeutic action with protamine and buffers. This product is a multi-constituent pharmaceutical preparation containing insulin, not put up in measured doses or for retail sale, and therefore falls under tariff item 3003.31.00.
Import Duty Rates by Country of Origin
| Origin Country | MFN Tariff | Surtaxes | Total Effective Rate |
|---|---|---|---|
| 🇨🇳China | Free | — | Free |
| 🇲🇽Mexico | Free | — | Free |
| 🇺🇸United States | Free | — | Free |
| 🇩🇪Germany | Free | — | Free |
| 🇯🇵Japan | Free | — | Free |
More Specific Codes
This product may fall under a more specific subheading:
Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If the product is put up in measured doses or in forms or packings for retail sale
Medicaments containing insulin, packaged for retail sale, are classified under heading 3004 rather than 3003.
Not sure which classification is right?
The Tariff Assistant works through the GRI rules on your specific product to reach the right tariff item — and can price the duty on it in the same conversation.
Import Tips & Compliance
• Ensure the product is clearly labeled as a bulk pharmaceutical preparation, not for retail sale, to avoid misclassification
• Provide a Certificate of Analysis and evidence of insulin content to support the tariff classification
• Verify whether a Drug Identification Number (DIN) is required for importation under Health Canada regulations
Related Products under Tariff item 3003.31.00
Bulk Insulin Glargine Solution
A bulk pharmaceutical preparation containing recombinant human insulin glargine, mixed with stabilizers and preservatives for therapeutic use in diabetes management. As a mixed medicament containing insulin, not in measured doses or retail packing, it is classifiable under tariff item 3003.31.00.
Insulin Aspart Injectable Bulk Solution
A sterile aqueous solution of insulin aspart with zinc and phenolic preservatives, supplied in bulk for further processing in diabetes therapy. This mixed insulin-containing preparation is not in measured doses or retail packing, so it belongs under tariff item 3003.31.00.
Insulin Detemir Long-Acting Bulk Prep
A bulk formulation of insulin detemir, a fatty acid acylated analog, mixed with phosphate buffers for basal insulin therapy. This mixed medicament contains insulin and is not put up in measured doses or for retail sale, placing it under tariff item 3003.31.00.
Insulin Lispro Premix Bulk Formulation
A bulk mixed suspension of insulin lispro protamine and regular insulin lispro for glycemic control, containing buffers and preservatives. As a multi-constituent insulin-containing medicament in bulk form, it is classifiable under tariff item 3003.31.00.
Recombinant Human Insulin Bulk Powder
A lyophilized powder formulation of recombinant human insulin mixed with mannitol and buffers for reconstitution in manufacturing. This bulk mixed therapeutic containing insulin, not in measured doses or retail packing, falls under tariff item 3003.31.00.
Regular Human Insulin Bulk for IV Use
A bulk regular human insulin solution with sodium chloride for intravenous hyperglycemic treatment, mixed for hospital compounding. This therapeutic mixed insulin preparation is not in measured doses or retail packing, so it is classifiable under tariff item 3003.31.00.