3002.51.00.00/CAR-T Cell Therapy for Leukemia/Canada

CAR-T Cell Therapy for Leukemia from Canada

Chimeric antigen receptor T-cell (CAR-T) therapy consists of patient-derived T-cells genetically modified to target CD19-positive cancer cells, used in treating relapsed B-cell acute lymphoblastic leukemia. Classified under HTS 3002.51.00.00 as cell therapy products, these are cell cultures modified via biotechnological processes for therapeutic use. They are administered intravenously after expansion and infusion preparation.

Duty Rate — Canada → United States

0%

Rate breakdown

9903.03.030%Articles the product of any country, as provided for in subdivision (aa)(ii) of U.S. note 2 to this subchapter
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Import Tips

• Obtain FDA Biologics License Application (BLA) approval and IND documentation prior to import; cell therapies require pre-approval

• Maintain ultra-low temperature cold chain (-150°C or cryopreserved) with validated shipping containers to preserve cell viability

• Avoid misclassification as general immunological products; provide biotech modification certificates to confirm cell therapy status