HS Code for Cell therapy products
Cell therapy products are classified under HS code 3002.51. This classification is part of the 2022 updates to the Harmonized System, designed to better categorize advanced therapy medicinal products (ATMPs). Under Chapter 30 (Pharmaceutical Products), heading 3002 covers biological materials. Subheading 3002.51 specifically targets products consisting of living cells that have been processed, modified, or otherwise prepared for administration to patients to treat, prevent, or cure diseases. These products are distinguished from standard cell cultures by their therapeutic intent and clinical application. The classification includes both autologous (patient-derived) and allogeneic (donor-derived) therapies. Because these products are highly regulated and often have short shelf lives, correct classification is vital for expedited customs clearance and regulatory compliance.
Products Included
- CAR-T cell therapies for oncology
- Mesenchymal stem cells for regenerative medicine
- Tissue-engineered products containing living cells
- Autologous chondrocyte implants
- Dendritic cell vaccines for immunotherapy
Common Misclassification
Cell therapy products are often misclassified under 3002.59, which is the residual category for "other" cell cultures used in research or industry. They may also be confused with 3001.90, which covers human or animal substances prepared for therapeutic use, such as extracts of glands. However, if the product consists of living cells for therapy, 3002.51 is the specific and correct code. Some importers also mistakenly use 3004.90 (medicaments), but biological cell-based products are prioritized under 3002.
FAQ
What is the HS code for cell therapy products?
The HS code for cell therapy products is 3002.51.
Are research-grade stem cells classified under 3002.51?
No, stem cells intended for research rather than direct therapeutic application in humans are generally classified under 3002.59.
Industry
Frequently Asked Questions
What is the HS code for Cell therapy products?
The HS code for Cell therapy products is 300251 (Cell cultures, whether or not modified; cell therapy products).
How do I classify Cell therapy products for customs?
Cell therapy products is classified under HS code 300251 — Cell cultures, whether or not modified; cell therapy products. This is a 6-digit subheading level code.
Is the HS code for Cell therapy products the same in all countries?
The base HS code 300251 for Cell therapy products is internationally standardized for the first 6 digits across 200+ countries. Individual countries may add additional digits for national tariff lines and specific classifications.