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Customs Clearance of Glutetimide | HS Code, Documents, Permits & Controlled Drug Requirements

Glutetimide Customs Clearance (HS Code + Documents & Permits)

Glutetimide is an important drug in the sedative–hypnotic class. Due to its potent effects on the central nervous system, it is prescribed for insomnia and anxiety relief. It is a controlled substance, meaning its import and clearance require strict compliance with rigorous laws and regulations. Because of potential misuse, its import/export is subject to stringent customs and health supervision.

For an estimate of time and cost to clear Glutetimide, contact Saba Tarkhis experts.

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1) HS Code & Customs Classification of Glutetimide

Tariff Code 29333990
In pharmaceutical imports, the HS Code (the Harmonized System for product classification) plays a vital role in customs clearance. Owing to its specific chemical composition and its status as a controlled medicine, Glutetimide is classified under chemical and pharmaceutical headings. It is generally classified within:
Chapter 29: Organic Chemicals
Chapter 30: Pharmaceuticals
The precise HS code may depend on factors such as dosage form (tablet, ampoule, etc.) and therapeutic use. To ensure full compliance and avoid legal issues, consult a customs specialist.

2) Documents Required for Glutetimide Clearance

Due to its high sensitivity, Glutetimide clearance requires specific documents and permits:
Ministry of Health / Food & Drug Organization (FDO) Permit: Import is only possible with an FDO permit, confirming quality and safety. Without it, clearance is impossible.

Health Certificate & Certificate of Pharmaceutical Authenticity: As a controlled medicine, it must be accompanied by health certificates from the country of origin confirming quality and authenticity.

Commercial or Therapeutic Import License: Importers need specific licenses (e.g., sanitary license or commercial import authorization) from competent authorities. Without them, the medicine may be detained.

Commercial Documents: Invoice, Packing List, and Bill of Lading/Air Waybill are mandatory to complete customs formalities, detailing price, quantity, weight, and shipment method.

3) Special Conditions for Import & Export of Glutetimide

Given its pharmaceutical nature and specific use, Glutetimide is subject to strict import/export controls in many countries. As a controlled substance with potential for misuse, its international trade is tightly regulated by supervisory bodies. In Iran, its import/export is governed by specific rules whose compliance is essential to avoid legal or operational issues.

4) International Controls on Controlled Medicines

Due to its CNS effects, Glutetimide is monitored by international bodies such as the WHO and the UNODC. To prevent misuse, they set strict rules for import, export, and consumption. In Iran, the Food & Drug Organization and the Islamic Republic of Iran Customs Administration oversee import control. Importers must obtain all requisite permits; non-compliance may result in seizure, heavy fines, or import bans.

5) Countries Exporting and Importing Glutetimide

Exporters: Advanced producers of chemical pharmaceuticals, including the United States, European countries such as Germany and France, and some Asian countries like India, are among the main exporters. With advanced pharmaceutical industries and strict production standards, they can export compliant products.
Importers: Key importers include Iran, Middle Eastern countries, some African nations, and countries in South America—primarily for therapeutic or research uses.

6) Import & Export Volumes of Glutetimide to/from Iran

Imports into Iran are generally limited and tightly controlled. Each year, specified quantities are brought in for hospital or research use, varying by domestic needs and FDO directives. Given the strict regulations, exports from Iran are generally not carried out.

7) Global Trade of Glutetimide

Global trade is more limited than many other drugs because Glutetimide is controlled and only permitted under specific therapeutic or research conditions. Annual trade volume is small versus common pharmaceuticals; producing countries supply most global demand.

8) Export Restrictions & Import Regulations

As a controlled medicine, exporting Glutetimide to certain countries—including Iran—requires special authorizations from the exporting state. Often, formal international agreements and special export licenses are needed. In Iran, importers must comply not only with domestic permits but also with the origin country’s export rules.

9) Customs Tariffs & Import Costs for Glutetimide

Tariffs for Glutetimide fall under sensitive/controlled pharmaceuticals, potentially differing—and sometimes higher—than other drugs. Tariffs depend on precise HS classification, which is often linked to dosage form (e.g., tablet or ampoule). In Iran, additional fees may apply for inspection, quality control, and laboratory testing.

10) Steps & Process for Clearing Glutetimide

Obtain Required Permits: First, secure the Ministry of Health / FDO permits prior to import.

Place Order in the Comprehensive Trade System: Register the order in the national trade portal and enter full shipment details (specifications, quantity, country of origin).

Submit Documents to Customs: Provide all permits, health certificates, and commercial documents (invoice, BL/AWB, etc.) for review and approval.

Specialist Checks & Sampling: Controlled medicines typically undergo quality checks; customs may sample and send to accredited labs to verify identity and composition.

Pay Duties & Taxes: After completion of examinations, pay duties/charges. Final release is issued thereafter.

11) Document Checklist for Glutetimide Clearance

As a sensitive, controlled drug, Glutetimide requires a precise set of documents to ensure quality, authenticity, and compliance:
1. FDO (Food & Drug Organization) Permit
Primary approval for quality, safety, and authenticity. Without it, clearance is impossible and the shipment may be detained.

2. Health Certificate
Issued by the exporting country, confirming production/packaging to international health standards.

3. Certificate of Origin
Confirms the place of manufacture and authenticity of the medicine.

4. Commercial or Therapeutic Import License
Authorization from the Ministry of Health/FDO or competent body to import the product legally.

5. Invoice
Details price, quantity, and payment terms for customs verification.

6. Packing List
Specifies number of packages, packaging type, and total weight.

7. Bill of Lading / Air Waybill
Official transport document showing route, carrier, and mode of shipment.

8. Certificate of Analysis (CoA)
Typically issued by the manufacturer, detailing the chemical composition and confirming quality compliance.

9. Customs Release Permit
Issued by Customs after reviewing and approving all documents.

10. Inspection Certificate
Issued after required inspections at entry, confirming physical/quality compliance with documentation.
Product Short Description HS Code
Glutetimide Sedative/Hypnotic; Controlled substance 29333990

Final classification depends on dosage form (tablet/ampoule), pharmaceutical grade, and therapeutic use.

Need precise HS Code determination, FDO permits, and document preparation? Our team manages the process end to end.

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FAQs

What is the HS Code for Glutetimide?

Typically classified under 29333990; the final determination depends on dosage form (tablet/ampoule) and technical documentation.

Which permits are required for import?

Permit from the Food & Drug Organization, health and authenticity certificates, where applicable a commercial/therapeutic import license, plus full commercial docs (Invoice, PL, BL).

What are the steps in the clearance process?

Obtain health permits, register the order in the national trade portal, submit documents to customs, sampling/testing, pay duties, and obtain clearance.

Media Suggestions

  • Image file name: glutetimide-customs-clearance-iran.jpg
  • Alt Text: Glutetimide customs clearance in Iran | HS 29333990 | Controlled medicine
  • Caption: “Glutetimide clearance steps: from FDO permit to accredited lab testing”
  • Infographic: “Checklist of documents, HS Code, and permit pathway for Glutetimide”

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Summary & Call to Action

As a controlled, multi-agency regulated product, Glutetimide clearance is sensitive and documentation-heavy. Saba Tarkhis leverages practical experience and regulatory expertise to move your case swiftly and compliantly.

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Premium Customs Services by Saba Brokerage

With extensive experience and a specialist team, we offer comprehensive services for clearing Glutetimide and other controlled medicines. These require strict compliance and multiple permits. We provide:

End-to-end expert guidance: From health and customs permits to final clearance, ensuring all steps are lawful and correct.
Permit acquisition: Full handling of paperwork with the Food & Drug Organization and Customs so you can import without hassle.
Speed in clearance: Leveraging practical know-how to release sensitive medicines as fast as possible, while remaining fully compliant.
Authenticity & quality assurance: Rigorous document checks to ensure your shipment meets sanitary and legal standards.

With our expertise in sensitive-drug clearance, we turn Glutetimide imports into a smooth, worry-free experience.

Contact our experts for more information.

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