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Customs Clearance for Loprazolam | HS Code 300490, Ministry of Health/IFDA permits & documents, controlled drugs import/export

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

Loprazolam Customs Clearance
Loprazolam, as one of the key medicines in the benzodiazepine group, is widely used to treat anxiety disorders and insomnia. By acting directly on the central nervous system, this medicine provides significant sedation and plays a crucial role in the treatment of short-term insomnia and neurological disorders. Due to the sensitive and controlled nature of this drug, its customs clearance requires strict compliance with complex regulations that demand great care.

To estimate the time and cost of Loprazolam customs clearance, contact the Saba Tarkhis experts.

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1) Uses of Loprazolam

Loprazolam is a psychoactive sedative and, due to its rapid and effective impact on reducing anxiety and relieving insomnia, is prescribed as a short-term medication. By acting on GABA receptors in the brain, it reduces neuronal activity and helps induce calm. However, because of possible physical and psychological dependence, the use of loprazolam is permitted only under a physician’s supervision and in a controlled manner.

2) Import Conditions and Customs Regulations for Loprazolam

1. Regulations for importing controlled medicines

Loprazolam is considered a controlled substance within the benzodiazepine class. Therefore, its import is subject to strict rules by the Iran Food and Drug Administration (IFDA). All importing companies must hold valid legal permits, and the drug may be imported only for legitimate purposes such as distribution to pharmacies and hospitals. Importing this medicine without permits leads to serious legal consequences, including seizure of the shipment and prosecution of the importer.

2. Documents required for Loprazolam clearance

For clearing controlled drugs like loprazolam, complete and accurate documentation is essential. Key documents include:
Import permit from IFDA: Confirms the importer is qualified to bring loprazolam into the country.
Prescribing/medical justification: The importer must prove the drug is being imported for legal medical use based on the needs of healthcare centers.
Health Certificate: Confirms the imported medicine meets required quality and international standards in the country of origin.
Commercial Invoice: Specifies shipment details including drug name, quantity, price, and seller/buyer information.
Packing List: Provides exact shipment details such as number of packages, net/gross weight, type of packing, and contents of each package.
Release authorization from the Ministry of Health: Confirms loprazolam is permitted to enter the country from a health standpoint.

3. HS Code and customs duty for Loprazolam

Loprazolam is classified under HS Code 300490. This code covers medicaments consisting of mixed or unmixed products for therapeutic use (including benzodiazepines and other psychoactive substances). Since benzodiazepines are heavily controlled, customs duties for importing such medicines are usually higher than ordinary drugs, and rates are influenced by international conventions governing controlled medicines. International conventions on psychotropic substances directly affect clearance processes and related tariffs.

3) Special Conditions for Importing and Exporting Loprazolam

1. Importing loprazolam into Iran

Due to the high sensitivity of this benzodiazepine, loprazolam can be imported into Iran only by reputable companies licensed by IFDA. These companies must comply with all regulations concerning psychotropic drug imports and obtain the necessary permits before importing. Importers are obligated to provide documentation related to the medicine’s quality and safety to IFDA and the Ministry of Health to ensure compliance with national and international standards.

Additionally, loprazolam imports are strictly monitored and recorded in official drug and health platforms. These systems log data such as import quantities, importing companies, and distribution. Such oversight aims to prevent misuse and smuggling of controlled medicines like loprazolam.

2. Exporting loprazolam to other countries

Exports of loprazolam also require international permits. These must be obtained from the destination country’s health authorities as well as international bodies such as the World Health Organization (WHO). Because loprazolam is controlled worldwide, exports to some destinations may face strict limitations.
That said, certain regional markets with frameworks similar to Iran’s for benzodiazepines may be suitable export targets. These include Iraq, Afghanistan, and Syria, where shortages and medical demand for such medicines exist.

4) Volume of Loprazolam Imports and Exports to/from Iran

According to available statistics, loprazolam imports to Iran originate from European countries such as Germany, France, and Switzerland major producers of benzodiazepines whose high pharmaceutical standards are recognized by IFDA. Annual imports to Iran amount to several thousand medicine packs, primarily distributed to hospitals and medical centers.
On the export side, shipments go to regional countries such as Iraq, Afghanistan, and Syria. Export volumes have increased in recent years due to rising demand, positioning Iran as one of the regional suppliers of benzodiazepines.

5) Global Circulation of Loprazolam

Global circulation of loprazolam is high due to its extensive use in treating insomnia and anxiety. The drug is imported and distributed under strict supervision in many countries. Key producing nations include Germany, Switzerland, France, the United Kingdom, and the United States—all major manufacturers of psychotropic medicines. Because of its importance in neuro-psychiatric therapy, global market value is rising annually and consistent supply is required.

6) Global Exporters and Importers of Loprazolam

Main exporters:

  • Germany: One of the largest producers and exporters of benzodiazepines.
  • Switzerland: Home to leading global pharma companies; a major exporter of loprazolam and similar medicines.
  • France: A leading country in manufacturing and exporting psychotropic medicines, including loprazolam.
  • United States: A major producer of benzodiazepines and exporter to many regions.

Main importers:

  • Iran: Imports loprazolam from Europe to supply healthcare facilities.
  • Iraq: Imports loprazolam from Iran and other regional suppliers due to domestic shortages of psychotropics.
  • Afghanistan & Syria: Importers of loprazolam due to limited domestic availability of psychotropic drugs.
  • Gulf countries: Some have high consumption of sedatives/psychotropics and are key import markets.

7) Required Documents for Loprazolam Customs Clearance

Because loprazolam is highly regulated, specific documents must be prepared and provided to complete customs clearance without issues or delays.

  1. 1. IFDA import permit
    The primary requirement confirming the importer’s authorization to bring loprazolam into Iran and that the product meets national health standards.
  2. 2. Health Certificate
    Issued in the country of origin, certifying proper sanitary production and acceptable quality and safety in line with international standards.
  3. 3. Commercial Invoice
    Provides full shipment details—price, quantity, seller/buyer data, and precise product specifications—for valuation and duty calculation.
  4. 4. Packing List
    Helps customs verify the shipment’s physical characteristics: number of packages, type of packing, net/gross weight, and contents per package.
  5. 5. Ministry of Health release letter
    Confirms the product is permitted to enter the domestic market from a health perspective after arrival.
  6. 6. Certificate of Origin
    Issued by the exporting country, indicating where the medicine was manufactured; essential for transparency and compliance.
  7. 7. Certificate of Analysis (COA)
    Provides test results and quality analysis from a recognized laboratory, detailing composition and quality specifications.
  8. 8. Customs release permit
    Issued after all documents are reviewed, authorizing official entry and distribution of loprazolam.
Item/Medicine Short Description HS Code
Loprazolam Benzodiazepine; controlled medicine; import by permit 300490

Exact subheading depends on dosage form, strength, packaging, and excipients.

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Frequently Asked Questions

What is the HS Code for loprazolam?

As noted above, loprazolam falls under 300490 (medicaments, ready for retail/therapeutic use).

Which permits are required to import loprazolam?

IFDA import permit, Ministry of Health release, Health Certificate, COA, plus commercial documents (Invoice, Packing List).

Are there export restrictions on loprazolam?

Yes. Exports require international permits and destination-country health approvals and are conducted under strict control in many jurisdictions.

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Specialized Customs Clearance Services by Saba Brokerage

As a reputable and leading company in clearing controlled and sensitive goods including psychotropic medicines like loprazolam we provide end-to-end services for importers and exporters, from initial consulting to final delivery.

Expert consulting on customs and pharmaceutical regulations: Our professional team, up-to-date on domestic and international rules for drug import/export, guides you to the best clearance strategies and full compliance.
Fast permit acquisition: With experience and strong connections across relevant agencies, we expedite permits from IFDA and the Ministry of Health and help prevent delays.
Document preparation and completion: We carefully review and prepare required documents such as commercial invoices, packing lists, and health certificates to ensure completeness and accuracy.
Customs process follow-up: Through ongoing follow-ups and direct communication with customs offices, we help ensure a smooth, swift release of your goods.
Reducing costs and clearance time: Our experience in cost management and optimal scheduling helps lower customs expenses and accelerate timelines.

With a specialized team and comprehensive services, Saba Brokerage can manage this process so your import and clearance of sensitive, controlled goods proceeds as smoothly as possible.

Contact our experts for more information.

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