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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) 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). (6) 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). (7) 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. (8) 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. (9) 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). (10) Appliances identifiable for ostomy use, that is, colostomy, ileostomy and urostomy pouches cut to shape and their adhesive wafers or faceplates. (11) Waste pharmaceuticals.
The heading also covers pharmaceutical products which are unfit for their original intended purpose due to, for example, expiry of shelf life. (12) Placebos.
The placebos under this heading are designed to mimic a medicament in appearance, and are for use in recognized clinical trials. A placebo is generally a pharmaceutically inert product that typically consists of the ingredients employed in the drug product under study minus the active ingredient. The placebos of this heading also include vaccines which are used as control substances and that have been licensed for use in recognized clinical trials. Placebos would come in a variety of forms including, but not limited to, tablets, liquids, injections and patches. The ingredients (excipients) employed in a drug product must be generally regarded as safe for use in humans, otherwise they could not be employed. (13) Blinded (or double-blinded) clinical trial kits.
Blinded (or double-blinded) clinical trial kits are for the sole purpose of blinded medical trials and contain either the trial medicaments, the corresponding placebos or both and are designed to anonymize the medicament. For new pharmaceutical trials, a randomized double-blind design is normally used. Information regarding the exact content of any given double-blinded kit i.e., whether it contains the active drug product or placebo or both, does not accompany the kit, and is not available for Customs purposes.
The kits may contain any item or packaging which is necessary solely for the safe transport or storage of the goods, for example, temperature recorders, tamper detectors or coolant pads and any associated and necessary documentation and forms whether in hard copy or electronic form.
Placebos or blinded (or double-blinded) clinical trial kits of this heading are put up in measured doses for use in recognised clinical trials.
Clinical trials are intended for human or animal drug trials, where the investigative products are the pharmaceutical forms of an active ingredient being tested or placebos used as a reference in the clinical trial. Active ingredients to be trialled can include herbal medicinal products for therapeutic or prophylactic uses.
Clinical trials kits are taken as recognised when they have fulfilled all relevant regulatory requirements in the country of import for the lawful import of such investigative products for use in the clinical trial.
Those "placebos" and "blinded (or double-blinded) clinical trial kits" products which are not for a clinical trial that has fulfilled the relevant regulatory requirements for the import of substances, should be classified respectively in other headings (e.g., headings 17.04, 21.06, etc.) based on their different composition and forms.
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