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30.06 - Pharmaceutical goods specified in Note 4 to this Chapter.
This heading covers only the following goods :(1) Sterile surgical catgut, similar sterile suture materials and sterile tissue adhesives for surgical wound closure.
This item covers all kinds of ligatures for surgical sutures, provided they are sterile. These ligatures are usually put up in antiseptic solutions or in sealed sterile containers.
The materials used for such ligatures include : (a) catgut (processed collagen from the intestines of cattle, sheep or other animals); (b) natural fibres (cotton, silk, linen); (c) synthetic polymer fibres, such as polyamides (nylons), polyesters; (d) metals (stainless steel, tantalum, silver, bronze).
The item also covers tissue adhesives such as those consisting of butyl cyanoacrylate and a dye; after application, the monomer polymerises and the product is therefore used in place of conventional suture materials for closing internal or external wounds of the human body.
The heading excludes non-sterile suture materials. These are classified according to their nature, e.g., catgut (heading 42.06), silkworm gut, textile yarns, etc. (Section XI), metal wire (Chapter 71 or Section XV). (2) Sterile laminaria and sterile laminaria tents.
This item is restricted to sterile laminaria and sterile laminaria tents (small lengths of algae, sometimes brown and with a rough grooved surface). They swell considerably on contact with moist substances and become smooth and flexible.
They are therefore used in surgery as a means of dilation.
Non-sterile products are excluded (heading 12.12). (3) Sterile absorbable surgical or dental haemostatics.
This item covers sterile products used in surgery or dentistry to stop bleeding and having the property of being absorbed by the body fluids. It includes oxidised cellulose, generally in the form of gauze or fibres ("wool"), in pads, pledgets or strip; gelatin sponge or foam; calcium alginate gauze, "wool" or "film". (4) Sterile surgical or dental adhesion barriers, whether or not absorbable. (5) Blood-grouping reagents.
The reagents under this heading must be suitable for direct use in blood-grouping. They are either sera of human or animal origin, or vegetable extracts of seeds or other parts of plants (phytagglutinins). These reagents are used in the determination of blood-groups by reference to the characteristics of the blood corpuscles or of the blood serum. In addition to the active principle(s), they may contain substances to strengthen their activity or stabilise them (antiseptics, antibiotics, etc.).
A. The following are to be regarded as reagents for determining blood-group by reference to the characteristics of blood corpuscles : (ⅰ) Preparations for determining the A, B, O and AB groups, A1 and A2 sub-groups and Factor H. (ⅱ) Preparations for determining the M, N, S and P groups and other groups such as Lu, K and Le. (ⅲ) Preparations for determining the Rh groups and Cw, F, V, etc. sub-groups. (ⅳ) Preparations for determining the blood-groups of animals.
B. The preparations to be regarded as reagents for determining the characteristics of sera are those used to determine : (ⅰ) characteristics of Gm, Km, etc., systems; (ⅱ) serum groups Gc, Ag, etc.
C. Anti-human globulin serum (Coombs serum), which is essential in certain blood-grouping techniques, is also to be regarded as a reagent of this heading.
Crude sera and other semi-finished substances which require further treatment before becoming suitable for use as reagents are to be classified by reference to their constituent material.
D. Reagents for the determination of HLA properties (HLA antigens) fall in this heading; they must be directly applicable. They are sera of either human or animal origin. These reagents react with peripheral blood lymphocytes of the test subject for the determination of the HLA antigens. The HLA antigens of the test subject may be determined on the basis of the reaction pattern of different HLA test sera. Besides the active ingredients the reagents contain additives for stabilisation and conservation.
These include : (a) Preparations for the determination of the HLA A, B and C antigens. (b) Preparations for the determination of the HLA DR antigens. (c) Preparations for the determination of the HLA D antigens. (d) Finishedreagents for the determination of the HLA A, B and C antigens which contain a range of different HLA antisera (e.g., test plates). (e) Finishedreagents for the determination of the HLA DR locus (e.g., test plates). (6) 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.
The opacifying preparations are used in X-ray examination of internal organs, arteries, veins, urinary passages, bile duct, etc. They are based on barium sulphate or other substances opaque to X-rays and may be put up for injection or for oral administration (e.g., barium meal).
The diagnostic reagents (including microbial diagnostic reagents) covered by the heading are those administered by ingestion, injection, etc.
Diagnostic reagents not designed to be administered to the patient (e.g., those for carrying out tests on blood, urine, etc., samples taken from a patient or for use as laboratory reagents) are excluded; they fall in the headings appropriate to the materials of which they are made (e.g., Chapter 28, Chapter 29 or heading 30.02 or 38.22). (7) Dental cements and fillings and bone reconstruction cements.
Dental cements and fillings are generally based on metallic salts (zinc chloride, zinc phosphate, etc.), metallic oxides, gutta-percha or plastic materials. They may also consist of metallic alloys (including precious metal alloys) specially prepared for dental fillings. Such alloys are sometimes called "amalgams" even though they do not contain mercury. The heading covers both temporary and permanent fillings and includes cements and fillings containing added medicinal substances and having prophylactic properties.
They are usually in the form of powders or tablets, sometimes accompanied by the liquid required for their preparation, and the packings normally indicate dental use.
Points (e.g., of silver, gutta-percha, paper) for filling dental root canals are also covered by this heading.
The heading also covers bone reconstruction cements, usually containing a hardener (curing agent) and activator and used, e.g., for attaching prosthetic implants to existing bone; these cements usually cure at body temperature.
Plasters specially calcined or finely ground for use in dentistry and preparations with a basis of plaster for use in dentistry are excluded (headings 25.20 and 34.07 respectively).
Bone graft substitutes, such as those made from surgical grade calcium sulfate, which provide a crystalline matrix on which new bone can grow as the matrix is resorbed are also excluded (heading 30.04). (8) First-aid boxes and kits.
These contain small quantities of a few common medicaments (hydrogen peroxide, tincture of iodine, mercurochrome, tincture of arnica, etc.), a few dressings, bandages, plasters, etc., and, optionally, a few instruments such as scissors, tweezers, etc.
The heading does not cover the more elaborate medical kits as used by doctors. (9) Chemical contraceptive preparations based on hormones, on other products of heading 29.37 or on spermicides, whether or not put up in packings for retail sale. (10) 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.
These preparations usually contain polyhydric alcohols (glycerol, propylene glycol, etc.), water and a thickener. They are generally used as a lubricant between parts of the body during physical examination (e.g., vaginal lubrication) or between the parts of the body and the surgeon's hands, gloves or medical instruments, for medical or veterinary purposes. They are also used as a coupling agent between the body and medical instruments (e.g., electrocardiograph, ultrasound scanner). (11) Appliances identifiable for ostomy use, that is, colostomy, ileostomy and urostomy pouches cut to shape and their adhesive wafers or faceplates. (12) Waste pharmaceuticals.
The heading also covers pharmaceutical products which are unfit for their original intended purpose due to, for example, expiry of shelf life.
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