3002 12 000 2 — Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products; cell cultures, whether or not modified: antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes: antisera and other blood fractions: antisera: other

3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; immune sera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products (+): – immune sera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes: 3002 11 – – malaria diagnostic test kits 3002 12 – – immune sera and other blood fractions 3002 13 – – immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale 3002 14 – – immunological products, mixed, not put up in measured doses or in forms or packings for retail sale 3002 15 – – immunological products, put up in measured doses or in forms or packings for retail sale 3002 19 – – other 3002 20 – vaccines for human medicine 3002 30 – vaccines for veterinary medicine 3002 90 – other

This heading covers: (A) Human blood (e.g. human blood in sealed ampoules). Animal blood prepared for therapeutic, prophylactic or diagnostic use. Animal blood not prepared for such purposes is classified in heading 0511. (B) Immune serums, other blood fractions and immunological products, modified or unmodified, including those obtained by biotechnology. These products include: (1) Immune serums and other blood fractions, modified or unmodified, including those obtained by biotechnology. Serums are liquid fractions separated from blood after clotting. This heading covers, inter alia, the following blood-derived products (including vascular endothelial cells): “normal” serums, human normal immunoglobulin, blood fractions and truncated variants (parts) thereof with enzyme properties/activity, plasma, thrombin, fibrinogen, fibrin and other blood clotting factors, thrombomodulin, blood globulins, serum globulins and hemoglobin. This category also includes modified thrombomodulins and modified hemoglobins obtained by biotechnology, for example, sothrombomodulin alfa (INN) and thrombomodulin alfa (INN), and those hemoglobins with cross-links, such as hemoglobin crosfumaryl (INN), hemoglobin glutamer (INN) and hemoglobin raffimer (INN). This heading also includes blood albumin (e.g. human blood albumin obtained by fractionation of blood fractions and truncated variants thereof with enzymatic properties/activity, whole human blood plasma) prepared for therapeutic or prophylactic use. Immune serums are obtained from human-to-human roe or blood of animals that are immune or specially immunized against diseases or pathological conditions caused by pathogenic bacteria and viruses, toxins or allergens, etc. Antiserums are used to treat diphtheria, e isentery, gangrene, meningitis, pneumonia, tetanus, staphylococcal or streptococcal infections, snake bites, poisoning with plant poisons, allergic diseases, etc. Antiserums are also used for diagnostic purposes, including in vitro tests. Specific immunoglobulins are purified antiserum-based drugs. This heading does not include blood albumin not prepared for therapeutic or prophylactic use (heading 3502) or globulins (other than blood globulins and serum globulins) (heading 3504). Nor does this heading cover medicinal products which are not derived from blood but which in some countries are called "serums" or "artificial serums"; they include isotonic solutions based on sodium chloride or other chemical compounds and a suspension of flower pollen which are used for the treatment of allergic diseases.

(2) Immunological products, whether or not modified, including those obtained by means of biotechnological processes. Products used for diagnostic or prophylactic purposes and in immunological tests are also regarded as products of this category. They may be defined as follows: (a) Monoclonal antibodies (MAB) – specific immunoglobulins produced from selected, cloned hybridoma cells cultured in a culture medium or in ascites; (b) Antibody fragments – fragments of antibody proteins obtained, for example, by specific enzymatic cleavage. This category includes, inter alia, single-chain (scFv) antibodies; (c) Conjugates of antibodies and antibody fragments – conjugates containing at least one antibody or one antibody fragment. The simplest types are the following combinations: (i) antibody – antibody; (ii) antibody fragment – antibody fragment; (iii) antibody – antibody fragment; (iv) antibody – other substance; (v) antibody fragment – other substance. Conjugates of types (iv) and (v) include, for example, enzymes (e.g., alkaline phosphatase, peroxidase or beta-galactosidase) or dyes (fluorescein) covalently bound to protein structures, used for direct detection reactions. This heading also covers interleukins, interferons (IFN), chemokines and certain tumour necrosis factors (TNF), growth factors (GF), haematopoietins and colony stimulating factors (CSF). (D) Vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products. These products include: (1) Vaccines. The most typical vaccines are prophylactic preparations of microbial origin containing either viruses or bacteria suspended in a saline solution, in oil (lipovaccines) or in other media. These preparations are usually treated to reduce their toxicity while retaining their immunological properties. Other vaccines include recombinant, peptide and carbohydrate vaccines. Such vaccines generally contain an antigen, a recognisable part of an antigen or the genetic code for a recognisable part of an antigen (peptides, recombinants or protein conjugates, etc.). A "recognisable part of an antigen" is the part of an antigen which initiates the immunological response of the organism. Many of these vaccines are directed against a specific virus or bacterium. Such vaccines are used for prophylactic or therapeutic purposes.

This heading also covers mixtures consisting of vaccines and toxoids (e.g., diphtheria, tetanus and pertussis (DSC) vaccine). (2) Toxins (poisons), toxoids, cryptotoxins, protoxins (e.g. topsalicin (INN)) and antitoxins. The toxins of this heading are peptides or proteins. These toxins do not include alkaloids (heading 2939). (3) Microorganism cultures (other than yeast) These cultures include enzymes such as lactic acid fermentation enzymes that are used in the production of dairy products (kefir, yogurt, lactic acid), and also include acetic fermentation enzymes that are used in the production of vinegar; micromycetes for the production of penicillin and other antibiotics; cultures of microorganisms used for technical purposes (for example, to stimulate plant growth). Milk or whey containing small amounts of mo fermentation enzymes are included in group 04. (4) Human, animal and plant viruses and antiviruses. (5) Bacteriophage. This heading also includes diagnostic reagents of microbial origin other than those referred to in Note 4(d) to this Chapter, see heading 3006. This heading excludes neither enzymes (rennet enzyme, amylase, etc.), even if they are of microbial origin (streptokinase, streptodornase, etc.) (heading 3507), nor dead single-celled microorganisms (other than vaccines) (heading 2102). (E) Diagnostic kits. Diagnostic sets are included in this heading if the main properties of the set are due to the products of this heading. Common reactions occurring with the use of such sets include agglutination, precipitation, neutralization, complement binding, hemagglutination, enzyme label immunosorbent assay (ELISA), etc. This heading covers diagnostic kits for the detection of malaria based on monoclonal antibodies to pLDH (lactate dehydrogenase plasmodium). The main properties are determined by the component that gives the most specificity to the diagnostic procedure. The products of this heading are included here whether or not they are packaged in dosage forms or in packages for retail sale and for sale in large or small packages. Explanation of the subheading. Subheading 3002 13 Unmixed immunological products of subheading 3002 13 may contain impurities. The term impurities applies exclusively to substances whose presence in products is solely and directly the result of the manufacturing process (including the purification process). These substances are obtained from any components involved in the process and are mainly the following substances: (a) unreacted starting materials; (b) impurities present in the starting materials; (c) reagents used in the manufacturing process (including purification);

(d) by-products.

Notes

Machine translation. The original is the Russian text of the EAEU tariff, and customs goes by it; this translation is for understanding only and has no legal force.

1. This group does not include:

(a) food or beverages (such as dietary, diabetic or nutritionally fortified foods, food additives, tonic beverages and mineral waters), other than nutrient preparations for intravenous administration (Section IV);

(b) products such as tablets, chewing gum or patches (transdermal systems) containing nicotine and intended to contribute to the cessation of tobacco consumption (heading 2404);

(c) specially calcified or finely ground plasters for use in dentistry (heading 2520);

(d) aqueous distillates or aqueous solutions of essential oils intended for medical use (heading 3301);

(e) preparations of headings 3303 to 3307, even if they have therapeutic or prophylactic properties;

(f) soap or other products of heading 3401 containing medicinal additives;

(g) g gypsum-based products for use in dentistry (heading 3407);

(h) blood albumin not prepared for therapeutic or prophylactic use (heading 3502); or

(ij) diagnostic reagents of heading 3822.

2. For the purposes of heading 3002, the term “immunological products” applies to peptides and proteins (other than those of heading 2937) which are directly involved in the regulation of immunological processes such as monoclonal antibodies (MABs), antibody fragments, antibody conjugates and antibody fragment conjugates, interleukins, interferons (IFNs), chemokines and certain tumor necrosis factors (TNFs), growth factors (GFs), hematopoietines and colony-stimulating factors (CSFs).

3. In headings 3003 and 3004 and note 4(d) to this chapter it is understood:

(a) unmixed products:

(1) unmixed products dissolved in water;

(2) all goods of Chapter 28 or 29; and

(3) simple plant extracts of heading 1302, only standardized or dissolved in any solvent;

(b) under mixed products:

(1) colloidal solutions and suspensions (except colloidal sulfur);

(2) plant extracts obtained by treatment of mixtures of plant raw materials; and

(3) salts and concentrates obtained by evaporation of natural mineral waters.

4. Heading 3006 covers only the following products, which are to be classified in this and no other heading of the Nomenclature:

(a) sterile surgical ketgut, similar sterile suture materials (including sterile absorbable surgical or dental threads) and sterile adhesive tissues for surgical wound closure;

(b) sterile kelp and sterile tampons of kelp;

(c) sterile resorbable surgical or dental hemostatic agents (hemostatics); sterile surgical or dental adhesive barriers, resorbable or non-absorbable;

(d) contrast preparations for X-ray examinations and diagnostic reagents intended for administration to patients, which are unmixed substances in dosage forms or substances consisting of two or more components mixed for such use;

(e) placebos and sets of impersonal clinical preparations for the conduct of approved clinical trials by simple blind (or double blind) method, packaged in dosage forms, even if they may contain active (active) medicinal substances;

(f) dental cements and other materials for filling teeth; cements for reconstructing bone;

(g) sanitary bags and first aid kits;

(h) chemical contraceptives based on hormones, other compounds of heading 2937 or spermicides;

(ij) preparations in the form of a gel intended for use in medicine or veterinary medicine as a lubricant for body parts in surgical operations or physical investigations or as a binding agent between the body and medical instruments;

(k) unsuitable pharmaceuticals, i.e. pharmaceutical products, which are not suitable for use for their original purpose, for example because they have expired; and

(l) devices identified as devices for stomic use, i.e. colostomy, ileostomy and urostomy bags cut in shape and their sticky plates or front parts.

Subheading notes

English text as published in Annex I to Regulation (EU) 2021/1832 (Combined Nomenclature). The EAEU tariff and the EU nomenclature copy these notes from the same convention. For a Russian declaration the binding version is the Russian one: Annex to Decision No 80 of the EEC Council of 14 September 2021.

1. For the purposes of subheadings 3002 13 and 3002 14, the following are to be treated:

(a) as unmixed products, pure products, whether or not containing impurities;

(b) as products which have been mixed:

(1) the products mentioned in (a) above dissolved in water or in other solvents;

(2) the products mentioned in (a) and (b) (1) above with an added stabiliser necessary for their preservation or transport; and

(3) The products mentioned in (a), (b) (1) and (b) (2) above with any other additive.

2. Subheadings 3003 60 and 3004 60 cover medicaments containing artemisinin (INN) for oral ingestion combined with other pharmaceutical active ingredients, or containing any of the following active principles, whether or not combined with other pharmaceutical active ingredients : amodiaquine (INN); artelinic acid or its salts; artenimol (INN); artemotil (INN); artemether (INN); artesunate (INN); chloroquine (INN); dihydroartemisinin (INN); lumefantrine (INN); mefloquine (INN); piperaquine (INN); pyrimethamine (INN) or sulfadoxine (INN).