3004.31.00: Insulin medicines, dosed or retail: Other, containing hormones or other products of heading 2937: containing insulin

1. This chapter does not cover:

1. (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);

2. (b) products, such as tablets, chewing gum or patches (transdermal systems), containing nicotine and intended to assist tobacco use cessation (heading 2404);

3. (c) plasters specially calcined or finely ground for use in dentistry (heading 2520);

4. (d) aqueous distillates or aqueous solutions of essential oils, suitable for medicinal uses (heading 3301);

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

6. (f) soap or other products of heading 3401 containing added medicaments;

7. (g) preparations with a basis of plaster for use in dentistry (heading 3407);

8. (h) blood albumin not prepared for therapeutic or prophylactic uses (heading 3502); or

9. (ij) diagnostic reagents of heading 3822.

2. For the purposes of heading 3002, the expression ‘immunological products’ applies to peptides and proteins (other than goods of heading 2937) which are directly involved in the regulation of immunological processes, such as monoclonal antibodies (MAB), antibody fragments, antibody conjugates and antibody fragment conjugates, interleukins, interferons (IFN), chemokines and certain tumour-necrosis factors (TNF), growth factors (GF), hematopoietins and colony-stimulating factors (CSF).

3. For the purposes of headings 3003 and 3004 and of note 4(d) to this chapter, the following are to be treated:

1. (a) as unmixed products:

   1. (1) unmixed products dissolved in water;

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

   3. (3) simple vegetable extracts of heading 1302, merely standardised or dissolved in any solvent;

2. (b) as products which have been mixed:

   1. (1) colloidal solutions and suspensions (other than colloidal sulphur);

   2. (2) vegetable extracts obtained by the treatment of mixtures of vegetable materials; and

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

4. Heading 3006 applies only to the following, which are to be classified in that heading and in no other heading of the nomenclature:

1. (a) sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure;

2. (b) sterile laminaria and sterile laminaria tents;

3. (c) sterile absorbable surgical or dental haemostatics; sterile surgical or dental adhesion barriers, whether or not absorbable;

4. (d) 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;

5. (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;

6. (f) dental cements and other dental fillings; bone reconstruction cements;

7. (g) first-aid boxes and kits;

8. (h) chemical contraceptive preparations based on hormones, on other products of heading 2937 or on spermicides;

9. (ij) 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;

10. (k) waste pharmaceuticals, that is, pharmaceutical products which are unfit for their original intended purpose due to, for example, expiry of shelf life; and

11. (l) appliances identifiable for ostomy use, that is, colostomy, ileostomy and urostomy pouches cut to shape and their adhesive wafers or faceplates.

1. For the purposes of subheadings 300213 and 300214, the following are to be treated:

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

2. (b) as products which have been mixed:

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

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

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

2. Subheadings 300360 and 300460 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).

1. Heading 3004 includes herbal medicinal preparations and preparations based on the following active substances: vitamins, minerals, essential amino-acids or fatty acids, in packings for retail sale. These preparations are classified in heading 3004 if they bear on the label, packaging or on the accompanying user directions the following statements of:

1. (a) the specific diseases, ailments or their symptoms for which the product is to be used;

2. (b) the concentration of active substance or substances contained therein;

3. (c) dosage; and

4. (d) mode of application.

This heading includes homeopathic medicinal preparations when they meet the conditions of (a), (c) and (d) mentioned above.

In the case of preparations based on vitamins, minerals, essential amino-acids or fatty acids, the level of one of these substances per recommended daily dose indicated on the label must be significantly higher than the recommended daily allowance to maintain general health or well-being.