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)                    Plasters specially calcined or finely ground for use in dentistry (heading 25.20);

 

(c)                     Aqueous distillates or aqueous solutions of essential oils, suitable for medicinal uses (heading 33.01);

 

(d)                    Preparations of headings 33.03 to 33.07, even if they have therapeutic or prophylactic properties;

 

(e)                    Soap or other products of heading 34.01 containing added medicaments;

 

(f)                      Preparations with a basis of plaster for use in dentistry (heading 34.07); or

 

(g)                    Blood albumin not prepared for therapeutic or prophylactic uses (heading 35.02).

 

2.‑ For the purposes of heading 30.02, the expression "modified immunological products" applies only to monoclonal antibodies (MABs), antibody fragments, antibody conjugates and antibody fragment conjugates.

 

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 and sterile tissue adhesives for surgical wound closure;

 

(b)                    Sterile laminaria and sterile laminaria tents;

 

(c)                     Sterile absorbable surgical or dental haemostatics;

 

(d)                    0pacifying 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;

 

(f)                      Dental cements and other dental fillings; bone reconstruction cements;

 

(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 re arations designed to be used in human or veterinary medicine as a lubricant for parts of the >v for surgical operations or physical examinations or as a coupling agent between the body and medical instruments; and

 

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

 

Explanatory remarks to chapter 30*

 

1-                       The importation and exportation of animal and veterinary medicines and biological substances are subject to the consent of the Ministry of Agriculture Jihad and the approval of the Ministry of Commerce.

 

 

2-                       Importation of medicines classified in this chapter is subject to the observance of Article 196 of the Third Economic, Social and Cultural Development Plan of the Islamic Republic of Iran.

 

3-                       Medicament classified in this chapter which is not manufactured so much as to meet the domestic demand, at the discretion of the Ministry of Health, Treatment and Medical Education or the Veterinary Organization, as appropriate, is liable to an import duty rate of 4% of the value.

 

4-                       Raw material of medicine which is not manufactured so much as to meet the domestic demand, at the discretion of the Ministry of Health, Treatment and Medical Education or Veterinary Organization, as appropriate, with reference to Note 2 of this chapter is liable to an import duty rate of 4% of the value.

 

 

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 sane factories in accrodance with the relevant regulations, shall be subject to the same customs duties as have 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 Directorate ‑ General 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 Directorate ‑ General 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 6 months from the date of clearance shall qualify for clearance.

 

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* The list of primary chemicals covered in this chapter whose importation requires the prior authorization of the Ministry of Foreign Affairs, on the strength of the Convention on prohibition of their use in chemical weapons as well as the observance of general regulations concerning imports and exports is annexed and shall be binding on all parties.

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