3004 49 000 8 — Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: other, containing alkaloids or derivatives thereof: other: other

3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: 3004 10 – containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives 3004 20 – other, containing antibiotics: – other, containing hormones or other products of heading 2937: 3004 31 – – containing insulin 3004 32 – – containing corticosteroid hormones, their derivatives or structural analogues 3004 39 – – other – other, containing alkaloids or derivatives thereof: 3004 41 – – containing ephedrine or its salts 3004 42 – – containing pseudoephedrine (INN) or its salts 3004 43 – – containing norephedrine or its salts 3004 49 – – other 3004 50 – other, containing vitamins or other products of heading 2936 3004 60 – other, containing antimalarial active principles described in Subheading Note 2 to this Chapter 3004 90 – other

This heading covers medicinal products consisting of mixed or unmixed products, provided that they are: (a) packaged in dosage form or in forms such as tablets, ampoules (for example, bidistillated water in ampoules of 1.25 to 10 cm3, used or for the direct treatment of certain diseases, for example, alcoholism, diabetic coma, or as solvents for the preparation of medicinal solutions for injection), capsules, starch capsules, drops or lozenges, drugs in the form of a single-use drug, in the form of a single dose, or in the form of a single-use system, or as a preventive dose.

This heading also covers medicaments in the form of transdermal administration systems, which are usually in the form of self-adhesive patches (generally rectangular or round) and are applied directly to the patient's skin. The active substance is contained in the part of the patch closed by a porous membrane on the side in contact with the skin. The active substance released from the patch is absorbed through the skin by passive molecular diffusion and enters directly into the bloodstream. Such systems should not be confused with the medical adhesive plasters of heading 3005. The heading covers single doses both in bulk packings and in packings for retail sale, etc.; or (b) Put up in packings for retail sale for therapeutic or prophylactic uses. This refers to products (e.g., sodium bicarbonate and tamarind powder) which, because of their packing and in particular the appropriate directions for use attached to them (statement of the disease or condition for which they are to be used, method of use or application, statement of dosage, etc.), are clearly intended for sale directly to users (private persons, hospitals, etc.) for use for the above purposes without repacking. These directions (in any language) may be given on the label, on a leaflet or elsewhere. However, the mere indication of pharmaceutical or other degree of purity is not in itself sufficient to justify classification in this heading. Nevertheless, unmixed products not accompanied by any directions are to be regarded as put up for retail sale for therapeutic or prophylactic uses if they are put up in a form clearly intended for such use. Medicaments consisting of mixed products for therapeutic or prophylactic uses, not put up in measured doses or in packings for retail sale, fall in heading 3003 (see the corresponding Explanatory Note). Under Note 3 to this Chapter, the following are also to be treated as unmixed products: (1) Unmixed products dissolved in water. (2) All goods of Chapter 28 or 29. Such products include colloidal sulphur and stabilised solutions of hydrogen peroxide. (3) Simple vegetable extracts of heading 1302 merely standardised or dissolved in any solvent (see the Explanatory Note to heading 1302). It should, however, be noted that unmixed products of headings 2843 to 2846 and 2852 are never classified in heading 3004, even if they satisfy the requirements of paragraph (a) or (b) above. For example, colloidal silver falls in heading 2843 even if put up in measured doses or packed and presented as a medicament. The heading covers pastilles, tablets, drops, etc., suitable only for medicinal purposes, such as preparations based on sulphur, charcoal, sodium tetraborate, sodium benzoate, potassium chlorate or magnesium oxide. However, goods put up as throat pastilles or cough drops, consisting essentially of sugar (whether or not they also contain other food substances such as gelatin, starch or flour) and flavouring agents (including substances having medicinal properties, such as benzyl alcohol, menthol, eucalyptol and tolu balsam), fall in heading 1704. Throat pastilles or cough drops containing substances having medicinal properties, other than flavouring

aromatic additives are included in this heading when packaged in the form of ozated dosage forms or in packages for retail sale, provided that the content of these substances in each lozenge or drop is sufficient for use for therapeutic or prophylactic purposes. This heading also includes the following products, provided they are manufactured in accordance with (a) or (b) above: (1) Organic surfactants and preparations with active cation (for example, salts of quaternary ammonium base), having antiseptic, disinfectant, bactericidal or germicidal action. (2) Polyvinylpyrrolidone-iodine, which is a product of the reaction of iodine and polyvinylpyrrolidone. (3) Bone graft substitutes made of calcium sulfate for surgical purposes, which are introduced into the cavity of the broken bone with a syringe and spontaneously dissolved and replaced with bone tissue; these products form a crystalline matrix on which new bone can grow as the matrix dissolves. However, this heading does not include bone-reconstructing cements normally containing a hardener (volcanic agent) and an activator used, for example, for attaching prosthetic implants to an existing bone (heading 3006). The provisions of this heading do not apply to foodstuffs or beverages, such as dietary, diabetic or nutritionally fortified foodstuffs, tonic beverages or mineral waters (natural or artificial), which fall in the relevant headings. This is usually the case with dietary supplements containing only nutrients. The main nutrients in foods are proteins, carbohydrates and fats. Vitamins and mineral salts also play a role in nutrition. Similarly, foodstuffs and beverages containing medicinal substances are not included in this heading if these substances are added for the sole purpose of improving the dietary balance, increasing the energy content or nutritional value of the product or improving its taste and aromatic qualities, provided that the product retains its properties as a food or beverage. In addition, products consisting of a mixture of plants or parts of plants, or of plants and parts of plants mixed with other substances, used for the preparation of herbal infusions or herbal “teas” (for example, herbal infusions or herbal “teas” having laxative, cleansing, diuretic or windward properties), and which are said to alleviate malaise or favorably affect general health and well-being, are also excluded from this heading (heading 2106). In addition, this heading does not include food additives containing vitamins or mineral salts which are prepared for the purpose of maintaining health and well-being, but have no indication of their use for the treatment or prevention of any disease. Such products, which are usually manufactured in liquid form but which may also be supplied in powders or tablets, are generally classified in heading 2106 or Chapter 22. However, this heading covers preparations in which a food product or drink serves as a carrier, a supplement or sweetener for medicinal substances (for example, to improve digestion). This heading also does not include: (a) snake or bee venom not supplied as a medicinal product (heading 3001); (b) goods of heading 3002, 3005 or 3006, however packaged; (c) aqueous distillates or aqueous solutions of essential oils and preparations of headings 3303 to 3307, even if they have therapeutic or prophylactic properties (heading 33); (d) soaps containing medicinal products, however packaged (heading 3401);

(e) insecticides, disinfectants, etc. of heading 3808, not intended for internal or external use as medicinal products; (f) preparations such as tablets, chewing gum or patches (transdermal systems) intended to help smokers quit (heading 2106 or 3824).

Wadding, gauze, bandages and similar articles (e.g., dressing material, adhesive patches, poultices) impregnated or coated with pharmaceutical substances or packaged in moulds or packages for retail sale intended for use in medicine, surgery, dentistry or veterinary medicine: 3005 10 – material dressing adhesive and other products having a sticky layer 3005 90 – other

This heading covers articles such as wadding, gauze, bandages and similar articles, of textile materials, paper, plastics, etc., impregnated or coated with pharmaceutical substances (anti-inflammatory, antiseptic, etc.), for medical, surgical, dental or veterinary purposes. These articles include wadding impregnated with iodine or methyl salicylate, etc., various prepared dressings, prepared poultices (e.g., of mustard or linseed), medicated adhesive plasters, etc. They may be in the piece, in discs or in any other form. Wadding and gauze for dressings (generally of absorbent cotton), bandages, etc., not impregnated or coated with pharmaceutical substances, are also classified in this heading provided they are put up in forms or packings for retail sale directly to private persons, clinics, hospitals, etc., without repacking, and have characteristics (presented in rolls or folded, in protective packings, labelled, etc.) that identify them as intended exclusively for medical, surgical, dental or veterinary use. The heading also includes the following types of dressings: (1) Skin dressings consisting of strips of frozen or lyophilised (freeze-dried) animal skin tissue, generally pigskin, used as temporary biological dressings for direct application to areas of damaged skin, open tissue wounds, surgical infection sites, etc. They come in various sizes, are put up in sterile packings (for retail sale) and are accompanied by instructions for use. (2) Liquid dressings, put up in aerosol form (for retail sale), used to cover wounds with a protective transparent film. Such dressings may contain a sterile solution of plastics (e.g., a modified vinyl copolymer or a methacrylate-based polymer) in a volatile organic solvent (e.g., ethyl acetate) and a propellant, whether or not with added pharmaceutical substances (in particular, antiseptics). The heading excludes bandages, adhesive plasters and the like containing zinc oxide, and plaster-coated bandages, not put up in forms or packings for retail sale for medical, surgical, dental or veterinary use. The heading further excludes:

(a) specially calcified or finely ground plasters and plaster-based formulations for dental purposes (headings 2520 and 3407, respectively); (b) medicinal products in the form of transdermal systems (heading 3004); (c) the goods referred to in note 4 to this chapter (heading 3006); (d) female sanitary pads and tampons, baby trees and diapers and the like articles of heading 9619.

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).