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Wednesday, October 26, 2022

Pharmaceutical products Regulation Bangladesh Customs Tariff

 

11 30.04 - Medicaments (excluding goods of healaing 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses packings for retail sale. (including those in the form of transdermal administration systems) or in forms or 3004.10 - Containing penicillins or derivatives thereof, with aenicillanic acid structure, or streptomycins or their derivatives p 3004.20 - Containing other antibiotics Containing hormones or other products of heading 29.37 but not containing antibiotics : 3004.31 - - Containing insulin 3004.32 - - Containing contortionist hormones, their derivatives or structural analogues 3004.39 - - Other

30.04

3004.40 - Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 29.37 or antibiotics 3004.50 - Other medicament containing vitamins or other products of heading 29.36

3004.90 - Other

This heading covers medicament consisting of mixed or unmixed products, provided they

are

(a) Put up in measured doses or in forms such as tablets, ampules (for example, re-distilled water, in ampules of 1.25 to 10 cm;, for use either for the direct treatment of certain diseases, e.g., alcoholism, diabetic coma or as a solvent for theoretician of inflection medicinal solutions). capsules. cachets, drops or pastilles, medicaments in the form of transdermal administration systems, or small quantities of powder, ready for taking as single doses for therapeutic or prophylactic use. The heading also includes measured doses in the form of transdermal administration systems which arc generally put up in the form of self-adhesive patches (usually rectangular or round) and which arc applied directly to the skin of patients. The active substance is contained in a reservoir which is closed by a porous membrane on the side entering into contact with the skin. The active substance released from the reservoir is absorbed by passive molecular diffusion through the skin and passes directly into the bloodstream. These systems should not be confused with medical adhesive plasters of heading 30.05. The heading applies to such single doses whether in bulk, in packing for retail sale, etc:: or

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(b) In packings for retail sale for therapeutic or prophylactic use. This refers to products (for example, sodium bicarbonate and tamarind powder) which, because of their packing and, in particular, the presence of appropriate indications (statement of disease or condition for which they are to be used, method of use or application, statement of dose. ctc.) are clearly intended for sale directly to users (private persons, hospitals. etc.) without repacking, for the above purposes. These indications (in any language) may be given by label, literature or otherwise. However, the mere indication of pharmaceutical or other degree of purity is not alone sufficient to justify classification in this heading. On the other hand, even if no indications are given, unmixed products are to be regarded as being put up for retail sale for therapeutic or prophylactic use if they are put up in a form clearly specialised for such use. Medicaments consisting of mixed products for therapeutic or prophylactic uses and not put up in measured doses or in forms or packings for retail sale arc classified in heading 30.03 (sec the corresponding Explanatory Note).

Under the terms of Chapter Note 3, the following are also regarded 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) Single vegetable extracts of heading 13.02, merely standardised or dissolved in any solvent (see the Explanatory Note to heading 13.02). It should be noted, however, that unmixed products of headings 28.43 to 28.46 and 2852 are always excluded from heading 30.04, even if they satisfy the requirements of paragraph (a) or (b) above. For example, colloidal silver remains classified in heading 28.43 even if put up in measured doses or packed and presented as a medicament.

This heading includes pastilles, tablets, drops, etc., of a kind suitable only for medicinal purposes, such as those based on sulphur, charcoal, sodium tetraborate, sodium benzoate, potassium chlorate or magnesia. However, preparations put up as throatpastilles or couch drops, consisting essentially of sugars (whether or not with other foodstuffs such as gelatin, starch or Pour) and flavouring agents (including substances having medicinal properties, such as benzyl alcohol, menthol, eucal),ptol and tolu balsam) fall in heading 17.04. Throat pastilles or cough drops containing substances having medicinal properties, other than flavouring agents, remain classified in this heading when put up in measured doses or in forms or packings for retail sale, provided that the proportion of those substances in each pastille or drop is such that they are thereby given therapeutic or prophylactic uses.

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The heading also covers the following products, provided they are put up as prescribed in  paragraph (a) or (h) above :

(1) Organic surface-active products and preparations, with active cation (e.g., quaternary, ammonium salts), having antiseptic, disinfectant, bactericidal or germicidal properties.

(2) Poly (vinyl pyrrolidone)-iodine, being a reaction product of iodine and poly (vinyl pyrrplidone).

(3) Bone graft substitutes, such as those made from surgical grade calcium sulfate, which arc injected Into a cavity of the fractured bone and spontaneously resorbed and replaced by bone tissue: these products provide a crystalline matrix on which new bone can grow as the matrix is resorbed.

However, the heading excludes bone reconstruction cements, usually containing a hardener (curing agent) and an activator and used, c.c., for attaching prosthetic implants to existing bone (heading 30.06).

The provisions of the heading text do not apply to foodstuffs or beverages such as dietetic, diabetic or fortified foods, tonic beverages or mineral %vatcrs (natural or artificial), which fall to be classified under their own appropriate headings. This is essentially the case as regards food preparations containing only nutritional substances. The major nutritional substances in food arc proteins, carbohydrates and fats. Vitam'ns and mineral salts also play a part in nutrition.

Similarly foodstuffs and beverages containing medicinal substances are excluded from the heading if those substances arc added solely to ensure a better dietetic balance, to increase the energy-giving or nutritional value of the product or to improve its flavour, always pmvided that the product retains its character of a foodstuff or a beverage.

Moreover, products consisting of a mixture of plants or parts of plants or consisting of plants or parts of plants mixed with other substances. used for making herbal infusions or herbal "teas" (e.g., those having laxative, purgative, diuretic or carminative properties), and claimed to offer relief from ailments or contribute to general health and Nye' I-being, are.also excluded from this heading (!leading 21.06).

Further, this heading excludes food supplements containing vitamins or mineral salts which arc put up for the purpose of maintaining health or well-being but have no indication as to use for the prevention or treatment of any disease or ailment. These products which arc usually in liquid form but may also be put up in powder or tablet form, are generally classified in heading 21.06 or Chapter 22.

On the other hand, the heading covers preparations in which the foodstuff or the beverage merely serves as a support, vehicle or sweetening agent for the medicinal substances (e.g., in order to facilitate ingestion).

The heading also excludes :

(a) Snake or bee venom, not put up as medicaments (heading 30.01).

(b) Goods of heading 30.02, 30.05 or 30.06, however they arc put up.

(c) Aqueous distillates or aqueous solutions of essential oils and preparations of headings 33.03 to 33.07, even if they have therapeutic or prophylactic properties (Chapter 33).

(d) Medicated soaps however they arc put up (heading 34.01).

(e) Insecticides, disinfectants, etc., of heading 38.03, not put up for internal or external use as medicines.

(f) Preparations, such as tablets, chewing gum or patches (transdermal systems). intended to assist smokers to stop smoking (heading 21.06 or 38.24).

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30.03 - Medicaments (excluding goods of hotting 30.02, 30.05 or 30.06) consisting of tvin etaailpseanleic.illani: clic more constituents which have been mixed together for therapeutic or prophvia" or uses, not put up in measured doses or in forms or packings for retail sale.

3003.10 - Containing penicillins . or derivatives thereof, structure, or streptomycins or their derivatives 3003.20 - Containing other antibiotics - Containing hormones or other products of heading 29.37 but not containing antibiotics :

3003.31 - - Containing insulin

3003.39 - - Other

3003.40 - Containing alkaloids or derivatives thereof but not containing hormones or other products of heading 29.37 or antibiotics

3003.90 - Other

This heading covers medicinal preparations for use in the internal or external treatment or prevention of human or animal ailments. These preparations arc obtained by mixing together two or more substances. However, if put up in measured doses or in forms or packings for retail sale, they fall in heading 30.04. The heading includes :

(1) Mixed medicinal preparations such as those listed in an official pharmacopoeia, proprietary medicines, etc., including those in the form of gargles, eye drops, ointments, liniments, injections, counter-irritant and other preparations not falling in heading 30.02, 30.05 or 30.06.

However, this should not be taken to mean that preparations listed in an official pharmacopoeia. proprietary medicines, etc. are always classified in heading 30.03. For example, anti-acne preparations which are designed primarily to cleanse the skin and which do not contain sufficiently high levels of active ingredients to be regarded as having a primary therapeutic orprophylactic effect against acne arc to be classified in heading 33.04.

(2) Preparations containing a single pharmaceutical substance together with an excipient. sweetening agent, agglomerating agent, support, etc.

(3) Nutritional preparations for intravenous administration only, i.e., by injection or drip into a vein.

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Colloidal solutions and suspensions (e.g., colloidal selenium) for medicinal purposes, but el) not including colloidal sulphur or single colloidal precious metals. Colloidal sulphur falls 11. heading 30,04 when. put up in measured doses or in pac1.-.ings for retail sale for iiiii„rapeutic or prophylactic uses and in heading 28.02 in all other cases. SinOe colloidal pr e metals fall in heading 28.43 whether or not put up for medicinal use. Mixtures of precious metals or mixtures of one or inure colloidal precious metals with other llcoi ioduasi cucobstances, for therapeutic or prophylactic purposes, are, hot wever, classified in this heading.

(5) medicinal compound vegetable extracts including those obtained by treating a mixture of plants.

(6) Medicinal mixtures of the plants or parts of plants of heading 12.11.

(7) Medicinal salts obtained by the evaporation of natural mineral waters and similar products artificially prepared.

(8) concentrated waters from salt sources (such as Kreuznach waters) used in therapeutics; mixed salts prepared for medicinal baths (sulphurous, iodized, etc., baths), whether or not perfumed.

(9) Health salts (e.g., a mixture of sodium hydrogencarbonate, tartaric acid, magnesium sulphate and sugar) and similar mixed effervescing salts used for medicinal purposes.

(10) Camphorated oil, phenolated oil, etc.

(11) Anti-asthmatic products such as anti-asthmatic papers and powders.

(12) " Retarded effect medicaments " such as those consisting of a medicinal component fixed to a polymeric ion-exchanger.

(13) Anaesthetics used in human or veterinary medicine or surgery.

The provisions of the heading text do not apply to foodstuffs or beverages such as dietetic, diabetic or fortified foods, tonic beverases or mineral waters (natural or artificial), which fall to be classified under their own appropriate headings. This is essentially the case as regards food preparations containing only nutritional substances. The major nutritional substances in food are proteins, carbohydrates and fats. Vitamins and mineral salts also play a part in nutrition.

Similarly foodstuffs and beverages containing medicinal substances are excluded from the heading if those substances arc added solely to ensure a better dietetic balance, to increase the energy-giving or nutritional value of the product or to improve its flavour, always provided that the product retains its character of a foodstuff or a beverage.

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plants mixed with other substances, used for making.herbal infusions or herbal Moreover, products consisting of a mixture of plants or Parts of plants or parts of plants mixed with other substances used for making herbal infusions or herbal "teas" (e.g, those having laxative, purgative, diuretic or carminative properties), and claimed to offer relief from ailments contribute to general health and well-being. arc also excluded from this heading (heading 21.06).

Further this heading excludes food supplements containing vitamins or mineral salts which are put un the purpose of maintaining health or well-being but have no indication as to use for the prevention `1* treatment of any disease or ailment. These products which are usually in liquid form but may also be Put up in powder or tablet form, are generally classified in heading 21.06 or Chapter 22.

On the other hand, the heading covers preparations in which the foodstuff or the beverage merely serves as a support, vehicle or sweetening agent for the medicinal substances (e.g., in order to facilitate ineestion).

In addition to foodstuffs and beverages, the heading excludes :

(a) Goods of heading 30.02, 30.05 or 30.06.

(b) Aqueous distillates or aqueous solutions of essential oils and preparations of headings 33.03 to 33.07, even if they have therapeutic or prophylactic properties (Chapter 33).

(c) Medicated soaps (heading 34.01).

(d) Insecticides, disinfectants, etc., of heading 38.08.

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Bangladesh Customs Tariff

Chapter 30

Pharmaceutical products

 

Notes.

1.- This Chapter elms 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 oil, 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.-

2. For the purposes of heading 30.02, the expression Immunological products" applies to peptides and proteins (cthcr 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, intcrferons (IFN), chemokines and certain tumor necrosis factors (TNF), growth factors (GF), hematopoietins and colony strnu!ating 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 12.02, 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 this Schedule-

(a) Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical cr 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 examination and diagnostic reagents designed to be administered to the patient, being unmixed products put up in measured doses or products consisting of hvo or more ingredients which have been mixed together for such uses;

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Bangladesh Customs Tariff

(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; First-aid boxes and kits;

(g) Chemical contraceptive preparations based on hormones, on other products of heading 29.37 or on spermicides;

(i) 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 colostomy use, that is, colostomy, liebstomy and urostomy pouches cut to shape and their adhesive wafers or faceplates.

Subheading Notes.

1.- For the purposes of subheadings 3002.13 and 3002.14, the following are to be treated :

(a) As unmixed products, pure products, tether 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).

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