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Customs Clearance of Alprazolam in Iran (HS Code 2933.99.00 + Documents & Permits)
For an estimate of the time and cost of clearing alprazolam and coordinating pharmaceutical permits, speak with the experts at Saba Tarkhis.
Instant Free Consultation1) Detailed description of alprazolam
2) Types and applications
- Common dosage forms (tablets/authorized forms) strictly by prescription and under the healthcare system’s supervision.
- Therapeutic use: management of anxiety and panic disorders per a specialist physician’s guidance; prescribing details are not provided on this page.
- Any distribution/use outside the medical and prescription framework is illegal.
3) Key points in customs clearance
- One of the most important documents for importing alprazolam is obtaining a permit from the Iran Food and Drug Administration. This permit indicates that the medicine is being imported for legal and therapeutic purposes and complies with all health standards. Without this permit, customs will not authorize the import of alprazolam.
Valid medical prescription:
In cases where the medicine is imported for personal use (especially during international travel), carrying a valid medical prescription is mandatory. The prescription must show that the patient needs alprazolam and should be translated into the official language of the destination country.
Certificate of Analysis and drug quality standards:
The Certificate of Analysis includes information about chemical composition, formulation, and quality standards. It is usually provided by the manufacturer and shows that the medicine meets international quality standards.
Commercial Invoice and Bill of Lading:
These documents include precise information about the foreign seller, price, product type, quantity, and mode of transport. Without them, customs cannot verify product specifications or complete clearance.
GMP (Good Manufacturing Practice) certificate:
The GMP certificate is a crucial document issued by the pharmaceutical manufacturer, confirming that the medicine has been produced under proper hygienic conditions and standards. It ensures that alprazolam meets quality requirements and is made from high-quality raw materials.
Controlled Substance Permit:
For medicines like alprazolam classified as controlled substances, a special permit from health and regulatory authorities is required. This permit shows that the import is performed under strict supervision and in accordance with the law.
4) Customs tariff (HS Code)
| Goods | Short description | HS Code |
|---|---|---|
| Alprazolam (controlled medicine) | Benzodiazepine; nitrogen-heterocyclic compound | 2933.99.00 |
Final classification is confirmed with the product label, authorized pharmaceutical form, and manufacturer documentation.
5) Special conditions for import and export
- Alprazolam is recognized worldwide as a controlled medicine due to its high potential for misuse and dependence. Its import and export are subject to very strict international and national regulations and are permitted only with special authorizations from pharmaceutical and health authorities. Many countries have highly complex and precise laws for controlling the import and export of alprazolam, and Iran is no exception.
Importing alprazolam into Iran
Import into Iran is possible only by licensed pharmaceutical companies and with approval from the Iran Food and Drug Administration. Before issuing an import permit, this authority carefully reviews product quality, manufacturer credibility, and domestic market need. The Iran FDA (IMED) is obligated to ensure that drug imports comply with national health and treatment standards. Any import without this permit is prohibited and subject to strict penalties.
Exporting alprazolam from Iran
Although Iran is a consumer of alprazolam, exports are also conducted under domestic and international laws. To export from Iran, pharmaceutical companies must obtain permits from the Ministry of Health and the Food and Drug Administration. Legal permits from the destination country are also necessary to prevent misuse during export procedures. Recipient countries must adhere to their own pharmaceutical and health approvals and prevent the import of controlled medicines without valid permits.
6) Iran market
7) Trade volume
According to official statistics, Iran is known as one of the main importers of alprazolam in the Middle East. Each year, a defined quantity is imported by reputable pharmaceutical companies. Due to high domestic demand for treating anxiety and panic disorders, the volume of imports is increasing. This medicine is commonly imported from countries such as the United States, Germany, Switzerland, and India. On the other hand, exports from Iran are lower due to regulatory sensitivities but can occur in specific cases with the necessary permits.
8) Global market
- Alprazolam is one of the best-selling medicines in the global psychopharmaceutical market. In recent years, global turnover has risen sharply due to increasing demand for anti-anxiety and anti-panic medications. The global market reaches billions of dollars, and developed countries are its largest consumers and producers. Statistics indicate that the United States is the largest producer and consumer of alprazolam, while European and Asian countries also hold significant shares in production and consumption.
Main exporters of alprazolam worldwide
Major exporters include advanced countries with sophisticated psychopharmaceutical manufacturing technology. Due to their ability to produce high-quality medicines and comply with global health standards, they are the top exporters. Some of these countries are:
United States: the largest producer and exporter of benzodiazepines.
Switzerland: one of the most reputable producers of psychopharmaceuticals worldwide.
Germany: a country with advanced pharmaceutical technology.
India: a major producer of generics with the capacity to export alprazolam widely due to lower production costs.
Main importers of alprazolam worldwide
Main importers are countries with high consumption for treating anxiety and mental disorders. Some key importers include:
Iran: due to increased need for anti-anxiety and psychopharmaceuticals.
Saudi Arabia: one of the largest consumers of psychopharmaceuticals in the region.
Turkey: widespread use of benzodiazepines.
European countries: such as France and Spain, where psychopharmaceutical imports are high.
9) Required documents for customs clearance
- Due to its sensitivity and pharmaceutical nature, clearing alprazolam requires specific steps that must be carried out with full care and submission of valid documents to customs. As a controlled medicine, its import is possible only with special permits and official documents from the relevant authorities.
1. Import permit from the Iran Food and Drug Administration (IMED)
One of the most important documents is the IMED permit. It confirms the legality of the import and compliance with national health and treatment standards. IMED issues this permit after reviewing product quality, the manufacturer, and market need; without it, import is not possible.
2. Valid medical prescription (for personal imports)
If imported for personal use, a valid prescription must accompany the medicine. It should explicitly show the patient’s need for alprazolam and, typically, an official translation into Persian is also required. The prescription must be written by a specialist, and supporting approvals may be needed.
3. Certificate of Analysis (COA)
The manufacturer’s COA is essential. It details chemical composition and formulation and confirms quality. Customs and IMED verify, through this certificate, that the imported medicine meets required standards and has been properly produced.
4. GMP (Good Manufacturing Practice) certificate
Issued by the manufacturer, it confirms production under appropriate hygienic conditions and global manufacturing standards. It demonstrates commitment to product quality and safety and is necessary for clearing alprazolam.
5. Commercial Invoice
This document includes full details on price, type, and quantity. It must be provided by the foreign seller and submitted to customs. Accurate details help determine customs value and calculate duties.
6. Bill of Lading
A vital transport document containing route, conveyance type, and related dates. Submission to customs is necessary to establish the legal entry route.
7. Controlled Substance Permit
Because alprazolam is a controlled medicine, a special import permit is required from the relevant regulatory bodies. It guarantees that the import is conducted under strict, legal supervision. Without it, import is prohibited.
8. Order Registration Certificate
For drug imports, this is a principal document issued by the Ministry of Industry, Mine, and Trade, indicating that the order has been legally registered. Order registration is the first stage and must be completed before shipment to Iran.
9. Confirmation of compliance with international standards
To ensure the imported medicine meets international pharmaceutical standards, the manufacturer must provide the necessary confirmations typically issued by accredited laboratories and send them with the consignment.
10. Certificate of Origin (CO)
This document specifies the country of manufacture. It helps determine tariff and duty and shows the medicine has been legally shipped from the producing country.
Need guidance on the IMED permit and Controlled Substance Permit? Our team manages your case end to end.
Submit a Proforma RequestFrequently Asked Questions
What is the HS Code for alprazolam?
Per your submitted data: 2933.99.00 (nitrogen-heterocyclic compounds/benzodiazepine derivatives). Final classification is confirmed with manufacturer documentation.
What permits are required for clearance?
IMED permit, Controlled Substance Permit, COA, GMP, order registration, and other trade documents (Invoice, B/L, CO, etc.).
Is personal import of this medicine possible?
Only within the law, with a physician’s prescription and official limitations observed. Any import without permits is prohibited.
How can we reduce clearance time?
Pre-classification of the tariff, obtaining permits before shipment, completing quality documents (GMP/COA), and using Saba’s specialized team for expert follow-ups.
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Summary & Call to Action
Clearing alprazolam as a controlled medicine requires precise classification, pharmaceutical permits, and quality documentation. With a specialized team, Saba Brokerage advances your process lawfully, quickly, and reliably.
Request Expert Consultation Get a Customs Proforma10) Clearance method in Iran + Saba Tarkhis special services
Proposed and safe steps
- Pre-classification: Confirm HS 2933.99.00 with manufacturer documents and authorized dosage form.
- Order registration & permits: Obtain IMED and Controlled Substance permits before shipment.
- Quality conformity: Compile COA, GMP, and authenticity documents; prepare for possible inspections.
- Declaration & valuation: Upload documents, respond to expert queries, and comply with labeling/packaging requirements.
- Clearance & safe delivery: Plan transport and delivery per pharmaceutical regulations; ensure full documentation.
Saba Tarkhis Special Services
With years of experience in clearing pharmaceutical and sensitive goods, Saba Brokerage is recognized as a leading broker in pharmaceutical customs. Leveraging our specialized team and full knowledge of drug import/export laws, we offer dedicated services for clearing alprazolam. Key services include:
Rapid acquisition of pharmaceutical permits: Our professionals, well-versed in controlled-substance laws, handle all steps to obtain required permits from the Iran Food and Drug Administration swiftly and accurately, preventing delays.
Preparation & management of required documents: We meticulously prepare and submit all documents Commercial Invoice, Bill of Lading, quality and analysis certificates to customs, ensuring full regulatory compliance for a smooth process.
Direct liaison with regulators and customs: Our strong connections with oversight bodies and customs accelerate clearance and help resolve issues promptly.
Specialized consulting on controlled-substance law: Given the complexity of relevant regulations, our legal and technical team provides essential guidance to avoid legal pitfalls.
Reducing costs and clearance time: Our core aim is to optimize processes and reduce client costs. Thanks to our experience and expertise, extra costs are minimized and clearance time is shortened.
By providing these specialized, comprehensive services, we are one of the best options for facilitating complex customs procedures and ensuring full compliance with health and pharmaceutical regulations when clearing alprazolam.
