chapter 30
Pharmaceutical products
Notes.
1. This Chapter does 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) preparations, such as tablets, chewing gum, or patches (transdermal systems), intended to assist smokers to stop smoking (heading 21.06or 38.24)
(c) Plasters specially calcined or finely ground for use in dentistry (heading 25.20);
(d) Aqueous distillates or aqueous solutions of essential oils, 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); or
(h) Blood albumin not prepared for therapeutic or prophylactic uses (heading 35.02).
2. For the purposes of heading 30.02 the expression “immunological products” applies to peptides and proteins (other 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, interferons (IFN), chemokinnes and ceratian tumor necrosis factors (TNF), geowth factors (GF), hematopoietins and colony stimulating 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 13.02, 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 the Nomenclature:
(a) Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or 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 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;
(e) Blood-grouping reagents; (including sterile absorbable surgical or dental yarns)
(f) Dental cement and other dental fillings; bone reconstruction cement;
(g) First-aid boxes and kits;
(h) Chemical contraceptive preparations based on hormones, on other products of heading 29.37 or on spermicides;
(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;.
(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 ostomy use, that is colostomy, ileostomy, and urostomy pouches cut to shape and the 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, 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 stabilizer 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); arteether (INN); artesunate (INN); chloroquine (INN); dihydroartemisinin (INN); lumefantrine (INN); mefloquine (INN); piperaquine (INN); pyrimethamine (INN) or sulfadoxine (INN).
Explanatory remarks to Chapter 30
1- The importation and exportation of animal and veterinary medicines and biological material are subject to the consent of the Ministry of Agriculture Jihad.
2- The importation of products indicated in this chapter by the symbol (■) in the considerations column, is limited to take the license of article 122, clause (چ) customs affairs rules.
Legal notes to Chapter 30
Note 1- Repealed
Note 2- Primary and packaging materials imported for the manufacture of medicines at the factories that are already established, or will be established in Iran with the authorization of the Ministry of Health or Directorate-General of Veterinary and which are imported in the names of the same factories in accordance with the relevant regulations, shall be subject to the same customs duties as having been levied on the foreign-made medicines, according to the table annexed to Customs Affairs Law, unless a lower customs duty is specified for the above-mentioned materials, provided that the description in terms of type, quantity, and place of use in each case is certified in writing by the Ministry of Health or DirectorateGeneral of Veterinary as the case may require. (provisions of this note shall also be binding in respect of the Commercial Benefit Tax).
Note 3 - In accordance with Article 16 of the law on foodstuffs, beverages, cosmetics, and sanitary materials adopted on 18 July 1967 (28.04.46), customs clearance of goods having a commercial attribute covered by tariff numbers 29.41, 30.01, 30.02, 30.03 and 30.05 shall be subject to the presentation of clearance permit issued by the Ministry of Health or the DirectorateGeneral of Veterinary (as the case may require). The validity period of clearance should be shown on such permits.
Note 4 - Of all pharmaceutical products with a consumption validity period (a specific span of therapeutic effectiveness), only those which have a remaining validity period of at least 65% from the date of clearance shall qualify for clearance.