Fluoxetine Hydrochloride Customs Clearance in Iran (HS Code + Documents & Permits)

1) Uses of Fluoxetine Hydrochloride

• Treatment of depression and psychiatric disorders
• Reducing anxiety and panic attacks
• Treatment of obsessive–compulsive disorder (OCD)
• Clinical uses in managing eating disorders

2) Technical Notes for Clearance

• Food & Drug Administration (IFDA) permit: Psychiatric medicines like Fluoxetine require a permit from the IFDA. This ensures the medicine is produced and distributed according to national health standards. Importers must provide all required documents to obtain this permit.
  
  Rigorous quality control: After the shipment arrives at customs, all medicines undergo strict quality checks to verify compliance with international standards and domestic regulations. Any quality deficiency may lead to return of goods or clearance delays.
  
  Proper and legal labeling: Under domestic rules, all medicines must be labeled in Persian (Farsi). Information such as dosage, manufacturing and expiry dates, warnings, and directions for use must appear on the packaging.
  
  Supervised transport: Because medicines are sensitive to storage conditions, their transport requires special handling. Importers must ensure optimal conditions during transport and storage so that product quality is maintained throughout the supply chain.

3) Tariff & HS Code

4) Special Import & Export Conditions

Fluoxetine Hydrochloride is widely used for depression and other psychiatric disorders. Owing to its therapeutic importance and global demand, its trade is closely monitored by pharmaceutical and customs authorities. As an SSRI, it is needed both in Iran and worldwide due to its effectiveness in improving symptoms of depression and anxiety.
Imports to Iran
Iran mainly imports Fluoxetine Hydrochloride from advanced European countries and some Asian countries. Germany, France, India, and China are key suppliers for the Iranian market, producing high-quality medicines under stringent health standards. Demand for psychiatric medicines has grown in recent years, increasing imports.

Exports from Iran
Exports from Iran are limited. Given high domestic demand and a focus on local supply, exports occur mainly to neighboring and regional markets. If domestic production exceeds demand, Iran may export Fluoxetine to countries such as Iraq, Afghanistan, and Central Asian states.

5) Import & Export Volumes to/from Iran

In recent years, imports of Fluoxetine Hydrochloride into Iran have grown due to increased need for psychiatric medicines. Significant volumes are imported annually from European and Asian countries. Exact volumes depend on economic and public-health conditions; during health crises (e.g., pandemics) demand can rise substantially.
Exports remain limited and mostly regional; volumes are small compared with imports, but could grow if domestic capacity increases.

6) Global Market Turnover

Global trade in Fluoxetine Hydrochloride is an important part of the pharmaceutical industry due to its widespread clinical use. Annual global turnover reaches billions of dollars, with leading exporting countries supplying many markets. Given its central role in psychiatric therapy, worldwide demand is expected to continue rising.

7) Major Exporters & Importers

Major exporting countries
Germany and France are among the top exporters, thanks to advanced pharma infrastructure and high standards. India and China also hold large shares due to scale and competitive pricing.

Major importing countries
Iran, Türkiye, Saudi Arabia, Brazil, and several Latin American nations are leading importers, driven by high demand and limited domestic production.

8) Required Documents

• Clearing Fluoxetine Hydrochloride—as a sensitive, high-importance medicine—requires precise documentation reviewed by both customs and health authorities. The process involves more detailed steps than general goods.
  Proforma Invoice:
  Includes all shipment details (price, weight, seller/buyer info, shipping terms). Forms the basis for cost and tariff calculations and is the first step in order registration.
  
  Certificate of Analysis (COA):
  Issued by the manufacturer, detailing product quality and composition. Confirms production to international standards and safety for use.
  
  Drug Registration Certificate (IFDA):
  Importers must hold IFDA registration for the product—official approval for import and use in Iran.
  
  Import License from the Ministry of Health:
  Mandatory for sensitive medicines like Fluoxetine, ensuring compliance with national laws and health standards.
  
  Health Certificate:
  Issued by the competent authority in the country of origin, confirming hygienic production and suitability for human use.
  
  Bill of Lading (B/L):
  The transport document detailing shipment and destination; proves legal shipment.
  
  Packing List:
  Details the number of packages, net/gross weight, and dimensions—used for customs examination.
  
  Customs Declaration:
  Complete information used to officially declare the shipment and pay applicable charges.
  
  Certificate of Origin (COO):
  Issued by the chamber of commerce in the producing country, used to determine applicable tariffs.
  
  Labeling compliant with domestic standards:
  All medicines must carry Persian labels including product name, composition, dosage, MFG/EXP dates, and health warnings.

Media Suggestions

• Image filename: fluoxetine-clearance-iran-hs-29334900.jpg
• Alt Text: Fluoxetine Hydrochloride Customs Clearance in Iran | HS 29334900
• Caption: “Fluoxetine clearance pathway: from Ministry of Health permits to COA”
• Infographic: “Document checklist + HS Code 29334900 + drug clearance workflow”

Suggested Links

• Saba Customs Clearance Services
• HS Code Selection Guide
• WHO, Wikipedia

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