Biological substance - category b & biological samples Hs Code

Biological substance - category b & biological samples harmonized system code

Product Overview Biological Substance - Category B and Biological Samples classified under HS Code 300290 encompass diagnostic or laboratory specimens that are infectious but do not meet the criteria for Category A substances. These materials include human or animal-origin biological samples such as blood, tissue, and body fluids intended for diagnostic or investigational use. Physically, these substances are typically liquid or semi-solid, transported in leak-proof, sterile containers with absorbent material to prevent contamination or leakage. Processing levels vary from minimally processed fresh specimens to stabilized or preserved samples, with quality attributes including integrity retention, pathogen viability control, and compliance with biosafety standards. The HS Code 300290 subcategories differentiate between diagnostic specimens, culture media, and other biological products not specified elsewhere. Commercially, these substances are critical for medical diagnostics, pharmaceutical research, and biotechnology applications, facilitating disease detection, vaccine development, and forensic analysis. Their value proposition lies in facilitating accurate laboratory testing and research while adhering to biosafety and regulatory compliance, making them indispensable across healthcare, research institutions, and industrial laboratories. HS Code Classification & Trade Specifications HS Code 300290 falls under Chapter 30 (Pharmaceutical Products), Heading 3002 (Human Blood; Animal Blood Prepared for Therapeutic, Prophylactic, or Diagnostic Uses; Antisera; Vaccines; Toxins; Cultures of Microorganisms). The subheading ‘90’ specifically designates “Other” biological substances, including Category B infectious substances and biological samples not classified as live cultures or vaccines. This classification is based on the product’s diagnostic purpose, infectious potential below Category A threshold, and exclusion from other defined categories. Trade considerations mandate packaging in UN-certified triple packaging systems conforming to IATA Packing Instruction 650 for air transport, ensuring containment, cushioning, and leak-proof integrity. Preservation methods typically include refrigeration at 2-8°C or freezing, depending on sample stability, with temperature monitoring to maintain sample viability. Quality standards align with WHO biosafety guidelines, ISO 15189 laboratory standards, and relevant national regulations to ensure traceability, sample integrity, and safe handling. Adherence to WTO Trade Facilitation Agreement provisions and harmonized system nomenclature ensures smooth customs clearance and compliance with international trade protocols.

Biological substance - category b & biological samples Chapter Note

1.- This Chapter does not cover : (a) Foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters), other than nutritional preparations for intravenous administration (Section IV); (b) Products, such as tablets, chewing gum or patches (transdermal systems), containing nicotine and intended to assist tobacco use cessation (heading 24.04); (c) Plasters specially calcined or finely ground for use in dentistry (heading 25.20); (d) Aqueous distillates or aqueous solutions of essential oils, suitable for medicinal uses (heading 33.01); (e) Preparations of headings 33.03 to 33.07, even if they have therapeutic or prophylactic properties; (f) Soap or other products of heading 34.01 containing added medicaments; (g) Preparations with a basis of plaster for use in dentistry (heading 34.07); (h) Blood albumin not prepared for therapeutic or prophylactic uses (heading 35.02); or (ij) Diagnostic reagents of heading 38.22. 2.- For the purposes of heading 30.02, the expression “immunological products” applies to peptides and proteins (other than goods of heading 29.37) which are directly involved in the regulation of immunological processes, such as monoclonal antibodies (MAB), antibody fragments, antibody conjugates and antibody fragment conjugates, interleukins, interferons (IFN), chemokines and certain tumor necrosis factors (TNF), growth factors (GF), hematopoietins and colony stimulating factors (CSF). 3.- For the purposes of headings 30.03 and 30.04 and of Note 4 (d) to this Chapter, the following are to be treated : (a) As unmixed products : (1) Unmixed products dissolved in water; (2) All goods of Chapter 28 or 29; and (3) Simple vegetable extracts of heading 13.02, merely standardised or dissolved in any solvent; (b) As products which have been mixed : (1) Colloidal solutions and suspensions (other than colloidal sulphur); (2) Vegetable extracts obtained by the treatment of mixtures of vegetable materials; and (3) Salts and concentrates obtained by evaporating natural mineral waters. 4.- Heading 30.06 applies only to the following, which are to be classified in that heading and in no other heading of the Nomenclature : (a) Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure; (b) Sterile laminaria and sterile laminaria tents; (c) Sterile absorbable surgical or dental haemostatics; sterile surgical or dental adhesion barriers, whether or not absorbable; (d) Opacifying preparations for X-ray examinations and diagnostic reagents designed to be administered to the patient, being unmixed products put up in measured doses or products consisting of two or more ingredients which have been mixed together for such uses; (e) Placebos and blinded (or double-blinded) clinical trial kits for use in recognised clinical trials, put up in measured doses, even if they might contain active medicaments; (f) Dental cements and other dental fillings; bone reconstruction cements; (g) First-aid boxes and kits;(h) Chemical contraceptive preparations based on hormones, on other products of heading 29.37 or on spermicides; (ij) Gel preparations designed to be used in human or veterinary medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments; (k) Waste pharmaceuticals, that is, pharmaceutical products which are unfit for their original intended purpose due to, for example, expiry of shelf life; and (l) Appliances identifiable for ostomy use, that is, colostomy, ileostomy and urostomy pouches cut to shape and their adhesive wafers or faceplates.