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Customs Clearance of Alfentanil | HS Code 300439, Documents & Permits, Specialized Transport of Controlled Medicines, Import/Export and Required Documentation

Customs Clearance of Alfentanil from Iran Customs (HS Code + Documents & Permits)

Alfentanil is a very potent and effective opioid used in managing pain and anesthesia in medical surgeries. Classified as a narcotic substance, it is particularly valued for its rapid onset and short duration of action, especially when immediate pain control is required. Importing and clearing this medicine, due to stringent international and domestic regulations, is a complex and sensitive process that requires strict adherence to health and legal principles.

For an estimate of the time and cost of Alfentanil customs clearance, contact the experts at Saba Tarkhis.

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1) Specialized Uses of Alfentanil

General anesthesia in short surgeries: Due to its rapid effect and short duration of action, Alfentanil is widely used in short and medium surgeries. It quickly enters the system and brings the patient into anesthesia within a short timeframe.
Control of severe and acute pain: As a strong opioid, Alfentanil is used to manage severe, acute pain that does not respond to other analgesics. It is highly effective in emergencies and whenever rapid pain control is required.
Postoperative pain control: In many cases after major or complex surgeries, patients experience severe pain. As a potent analgesic, Alfentanil is used post-surgery to reduce pain and prevent pain-induced shock.

2) Key Points in Customs Clearance of Alfentanil

Clearing sensitive medicines such as Alfentanil from customs requires adherence to a set of precise laws and complex regulations due to its controlled nature and health sensitivities. The most important stages and points are as follows:
Obtaining legal and health permits: Importing Alfentanil requires official permits from the Food and Drug Administration and the Ministry of Health. These permits are granted only to official importers with the necessary approvals. Given the drug’s controlled nature, any import or export must be conducted under strict government supervision, and any violation may lead to serious consequences.

Order registration in the Comprehensive Trade System: Before import, all orders must be registered in the Comprehensive Trade System. As one of the initial customs stages, this system records and controls all import-related information. Importers are obligated to submit complete and accurate documents at this stage.

Quality control and laboratory approvals: Each Alfentanil shipment must undergo quality control by specialized laboratories. These tests include a thorough examination of the drug’s composition and verification of authenticity. Without a valid laboratory certificate, clearance is not possible. Health supervision and quality testing must comply with international standards.

Specialized transport methods: Due to the high sensitivity of this drug, the use of specific transport methods is mandatory. Opioids must be moved in special containers in compliance with medical transport standards. Using suitable containers to maintain quality and efficacy throughout transit is of great importance.

Strict customs regulations: Since Alfentanil is classified as a narcotic, stringent rules govern its clearance. These include thorough inspections, complete documentation, and submission of all required certificates and permits. Any legal violations or non-compliance may result in detention or rejection of the shipment.

3) Tariff and HS Code of Alfentanil

Alfentanil is classified under HS Code 300439. This code refers to medicaments in measured doses or in forms or packings for retail sale that are used directly for medical purposes. However, due to the drug’s specific nature and international controls on narcotics, different tariffs may apply depending on the laws and regulations of the importing country.
Goods Short Description HS Code
Alfentanil Opioid medicament in dosage form 300439

The precise subheading depends on dosage form, concentration, packaging, and therapeutic use.

4) Special Conditions for Import and Export of Alfentanil

As a sensitive and controlled medicine, Alfentanil is subject to strict international and domestic regulations. Since it is categorized as a narcotic and its uses are limited to specialized medical settings, importing and exporting it requires close supervision and obtaining special permits.

Importing Alfentanil into Iran

Importing Alfentanil into Iran is only possible through official pharmaceutical importers and under the strict supervision of the Ministry of Health and the Food and Drug Administration. To bring this drug into the country, the importer must have legal and official permits from the relevant authorities. This medicine is usually imported from major producing countries such as Germany, France, and the United States. These countries are leaders in manufacturing narcotic and anesthetic medicines and, by observing stringent health standards, supply opioid medicines like Alfentanil to global markets.

Exporting Alfentanil from Iran

Exports of this medicine from Iran are highly limited. Due to international and domestic narcotics laws, exporting Alfentanil is possible only in specific cases and with special permits. Any export requires coordination with international bodies and adherence to health and legal protocols.

Volume of Alfentanil Imports and Exports to Iran

Because of the high sensitivities and strict regulations governing the import of this drug in Iran, the volume of imports is relatively low and limited to medical and hospital needs. Imports are generally for specialized medical centers such as hospitals, clinics, and surgical centers. Due to the controlled and narcotic nature of this drug, detailed information on import and export volumes is not publicly released. However, data indicate that Iran has imported limited amounts in recent years, adjusted to the country’s medical needs.

Global Circulation of Alfentanil

Alfentanil is a specialized medicine in anesthesia and acute pain control. Its global circulation is lower than that of general medicines because it is used only in surgeries and specific medical circumstances. The largest producing countries include Germany, France, the United States, and Japan, which, due to their advanced pharmaceutical industries, undertake most of the production and export. The primary consumer markets are in countries that lack domestic production capacity and rely on imports from producing countries.

5) Main Exporters and Importers of Alfentanil

Major Alfentanil Exporters Worldwide

Advanced countries with strong pharmaceutical infrastructure such as Germany, the United States, France, and Japan are among the largest exporters of Alfentanil. By complying with strict international standards for manufacturing and packaging narcotic medicines, these countries have captured global markets for this drug.

Major Alfentanil Importers Worldwide

Countries that need this medicine but lack the capacity to produce it are known as the main importers of Alfentanil. These include Middle Eastern countries, some Asian nations, and African countries. Due to the inability to produce opioid medicines, these regions rely on imports from producing countries to meet medical needs.

6) Required Documents for Clearing Alfentanil

Clearing Alfentanil, as an opioid classified among narcotic substances, requires specific documents. This medicine must be imported and cleared under the strict supervision of legal and health authorities. The required documents include health permits and records related to transport and drug quality. Details are as follows:
  1. 1. Import permit from the Ministry of Health and the Food & Drug Administration
    For clearing Alfentanil, the first and most important document is the official permit from the Ministry of Health and the Food & Drug Administration. Without this permit, importing and clearing the medicine is not possible. The permit must include accurate information on the importer, the drug type, and the import quantity.
  2. 2. Order registration in the Comprehensive Trade System
    To begin the import process, order registration in the Comprehensive Trade System is necessary. At this stage, all shipment details—including drug specifications, producing country, and other particulars—are recorded. Without approval of this order, subsequent import steps are not possible.
  3. 3. Drug Registration Certificate (IRC)
    This certificate shows that the drug has been registered and approved in the country. It must be issued by the Ministry of Health and include exact drug specifications, composition, and medical uses.
  4. 4. Purchase invoice (Invoice)
    The purchase invoice includes precise information such as price, quantity, and drug specifications, issued by the seller. It is a key financial document submitted to customs for clearance.
  5. 5. Transport insurance policy
    To ensure shipment safety during transit, a transport insurance policy is essential. It guarantees compensation for any damage or unforeseen incidents during transit.
  6. 6. Certificate of Origin
    Issued by the chamber of commerce of the exporting country, it shows where the medicine was produced. It is one of the mandatory documents for customs clearance.
  7. 7. Certificate of Analysis (COA)
    Issued by the manufacturer or an accredited laboratory, the COA provides information on the drug’s composition and quality. It is essential to ensure authenticity and quality of the shipment.
  8. 8. Transport document or Bill of Lading
    The bill of lading indicates transport details and must include specifics such as the transport mode, container number, and the drug’s route. It is one of the vital documents in the clearance process.
  9. 9. Health certificates and international standards
    For importing sensitive medicines, health certificates and compliance with international standards are essential. They confirm that the drug has been produced and packed under appropriate sanitary conditions.
  10. 10. No-Objection Certificate (NOC)
    Issued by the relevant authorities, the NOC confirms there is no obstacle to clearing the medicine from customs. Depending on the importing country’s laws, it may be issued by health or security bodies.
  11. 11. Customs release note
    Finally, after verification and approval of all documents by customs, the release note is issued, providing the final authorization for the shipment to exit customs.

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Frequently Asked Questions

What is the HS Code for Alfentanil?

Alfentanil is generally classified under 300439 (medicaments for retail sale); the final subheading depends on dosage form, concentration, and packaging.

What permits are required to import Alfentanil?

Official permits from the Ministry of Health and the Food & Drug Administration, order registration in the Comprehensive Trade System, and quality/laboratory approvals are mandatory.

How should this medicine be transported?

Using specialized pharmaceutical containers and in accordance with medical transport standards; maintaining quality chain and health supervision along the entire route is essential.

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Summary & Call to Action

For fast and compliant clearance of Alfentanil, completing health permits, accurate order registration, and adhering to specialized transport standards are essential.

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Special Customs Clearance Services by Saba Brokerage

Saba Brokerage, with extensive experience in clearing sensitive and controlled medicines, including Alfentanil, offers comprehensive, specialized services to importers. These services include:

Specialized consulting and order registration: With full knowledge of regulations related to importing sensitive medicines, these services help importers act correctly from start to finish, including obtaining permits and registering orders in the Comprehensive Trade System. Ensuring accurate order registration and obtaining necessary permits from relevant organizations is one of the main steps to expedite clearance of sensitive medicines.
Coordination with accredited laboratories: Throughout the clearance process, coordination with specialized laboratories approved by the Food and Drug Administration is highly important. Ensuring quality and authenticity of imported medicines through necessary tests and obtaining quality certificates helps importers clear their medicines with confidence.
Continuous follow-up in the clearance process: Continuous, precise tracking of all clearance stages from initiation to receipt of the final shipment is another key point. Professional teams, by monitoring the process, prevent any issues or delays.
Specialized transport: Given the high sensitivity of transporting opioids and controlled substances, choosing the best transport methods and using standard equipment is essential. Ensuring shipment health and safety during transit is of great importance, and these specialized services can safeguard the shipment until it reaches its final destination.
Fast and compliant clearance: Full mastery of customs laws and cooperation with government and customs bodies enables faster and more accurate clearance of sensitive medicines. These services help importers clear their medicines in the shortest possible time without legal problems.

By using these comprehensive services, importers of sensitive medicines can, with confidence in compliance with all regulations and legal requirements, carry out their clearance process optimally and quickly.

For more information, contact our experts.

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