Clearance of Sodium Valproate from Customs | Pharmaceutical HS Code (HS 3003/3004), IFDA (Food and Drug Administration of Iran) permit, drug transport requirements, and necessary documents

Sodium Valproate Clearance from Iranian Customs (HS Code + Documents & Permits)

Clearance of sodium valproate from customs: Sodium valproate is one of the essential and widely used medicines in medical science, used as a drug to control various neurological disorders such as epilepsy, bipolar disorder, and migraine. Due to its anticonvulsant properties, this medicine is considered one of the key drugs in the treatment of epilepsy. Given the sensitivity and importance of sodium valproate in the field of medicine, its import into countries requires strict compliance with health and customs regulations. The import and clearance of this pharmaceutical substance from customs requires special care and attention to ensure that the imported product complies with international and national standards and that its authenticity and quality are guaranteed. Due to the sensitivities associated with this drug, its clearance steps must be carried out with particular precision so that patients’ health is not compromised under any circumstances.

For estimating the time and cost of clearing Sodium Valproate with the experts at Saba Tarkhis, please get in touch.

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1) Steps and Key Points in Clearing Sodium Valproate

Import permits for pharmaceuticals from the Food and Drug Administration (IFDA) are one of the main stages in the clearance process of sodium valproate; obtaining a permit from the IFDA is essential. This permit must include approvals confirming the quality and authenticity of the drug. As a sensitive substance, sodium valproate must be subject to strict quality and health controls. In addition to quality reviews, the Food and Drug Administration must confirm that this drug is suitable for distribution in the Iranian market. These permits are usually issued after reviewing and approving the manufacturer’s documents, and without them, importing the drug will be illegal.

2) Health Documents and International Certificates

To import sodium valproate into Iran, importers are required to provide health and quality certificates from the manufacturer. These certificates include:

Certificate of Analysis (COA): This certificate states the precise composition of the drug and the purity of its active ingredients and ensures that the medicine conforms to the declared specifications.
GMP (Good Manufacturing Practice) Certificate: This certificate indicates that the manufacturer has produced the medicine under hygienic conditions and strict international standards. Drugs bearing this certificate are subject to rigorous inspections and exported to global markets.

Without providing these certificates, the clearance of the drug from customs will be very complicated and time-consuming, and in some cases the import may be rejected due to non-compliance with requirements.

3) Optimal and Standard Transport of Medicines

Transporting medicines—especially sensitive drugs like sodium valproate—must be carried out under specific hygienic conditions. This medicine must be transported at a controlled temperature to prevent reduced efficacy or changes in its chemical structure. Also, medicine packaging must be fully labeled, and precise pharmaceutical specifications must be listed on it. Adhering to standards for transporting medicines is critical, because any deficiency at this stage may damage the drug and consequently lead to bodily and financial harm.

4) Compliance with International Pharmaceutical Standards

Sodium valproate falls under the standards of the World Health Organization (WHO) and the FDA (U.S. Food and Drug Administration). For importing this drug into Iran, compliance with international standards is essential. Importers must ensure that the medicine is produced and packaged in accordance with international standards and that no damage occurs to it during transportation.

5) Customs Tariff for Sodium Valproate (HS Code)

Sodium valproate is classified under pharmaceuticals, and its customs tariffs are usually determined based on the HS Code related to anticonvulsant drugs and active substances for treating psychiatric disorders. Generally, this product falls under HS 3003 and HS 3004, which refer to medicaments not in measured doses and medicaments in measured doses and packaged for retail sale. Customs tariffs may vary depending on each country’s trade and health policies. In Iran, for importing medicines such as sodium valproate, lower tariffs are applied to enable importers to supply this drug more quickly and at lower cost.

Goods	Short Description	HS Code
Sodium Valproate	Anticonvulsant; active ingredient / measured-dose retail medicament	3003 / 3004

The exact heading is determined based on the presentation form (bulk/dosed), grade, packaging, and use.

6) Specific Conditions for Importing and Exporting Sodium Valproate

Import into Iran

Sodium valproate, as a vital medicine for patients with epilepsy and neurological disorders, plays a very important role in Iran’s pharmaceutical market. Due to the lack of mass domestic production and the extensive needs of hospitals and medical centers, importing this medicine into Iran is of particular importance. This drug is mainly imported from Germany, India, and China. These countries are leaders in manufacturing advanced and generic medicines and have the capacity for high-volume production. Imports of sodium valproate into Iran are regulated based on domestic needs and consumption levels within the country’s health-care system. Due to the sensitivities related to this medicine, all import processes are strictly supervised by the Food and Drug Administration.

Export from Iran

At present, Iran is not a primary producer of sodium valproate, and most domestic needs are met through imports. Therefore, the export of this medicine from Iran to other countries is very limited. However, if Iran gains the capability to produce this drug more extensively in the future, exporting it to regional and neighboring countries could create a new market for Iran’s pharmaceutical industry.

Import and Export Volumes of Sodium Valproate to Iran

The import volume of sodium valproate into Iran is relatively high due to the importance of this drug for patients with epilepsy, bipolar disorder, and other neurological problems. The import of this drug is carried out regularly and continuously, and its amount is adjusted based on the annual needs of the country’s health-care system. Due to the continual domestic demand for this medicine, its import into Iran has always been at high levels. Detailed public information on the import and export volume of this drug may not be fully available due to sensitivities associated with the pharmaceutical market.

Global Circulation of Sodium Valproate

Globally, sodium valproate is one of the main drugs used to control seizures and neurological disorders. Its global circulation involves extensive trade between producing and consuming countries. Major manufacturers continuously export sodium valproate to various markets worldwide because demand for this drug is very high in many countries. The global trade volume of sodium valproate is significant due to the widespread needs in medical and health sectors, especially for treating patients with epilepsy.

7) Global Exporters and Importers of Sodium Valproate

Global Exporters of Sodium Valproate

Germany: One of the leading exporters of sodium valproate, producing high-quality pharmaceutical products using advanced technologies.
India: As one of the largest producers of generic medicines, it plays an important role in meeting global demand for sodium valproate.
China: Due to its mass production of pharmaceutical raw materials, China is a major exporter of sodium valproate and other pharmaceutical substances to many countries worldwide.

Global Importers of Sodium Valproate

Iran: One of the major importers of this medicine to meet domestic needs.
Gulf Cooperation Council countries: These countries import sodium valproate on a large scale due to the broad need for anticonvulsant drugs for patient treatment.
Turkey: Another major importer that brings sodium valproate from producing countries for use in its hospitals and medical centers.

8) The Best and Simplest Method for Clearing Sodium Valproate

Clearing sodium valproate, due to its sensitivity as a medicine and the need to comply with health regulations and international standards, requires specific and precise steps. The best method for clearing this product from customs includes the following stages: Obtaining the necessary permits from the relevant organizations: including permits from the Food and Drug Administration and the Ministry of Health. Without these permits, it is not possible to clear the goods from customs. Providing complete health and quality documentation: importers must present valid international certificates such as the Certificate of Analysis (COA) and the GMP (Good Manufacturing Practice) certificate to ensure the quality and authenticity of the imported product. Using specialized customs brokerage services: taking advantage of experienced customs brokers can speed up the clearance process and prevent potential problems. Brokers, familiar with customs regulations and procedures, can correctly prepare the required documents and submit them to the relevant organizations.

9) Required Documents for Clearing Sodium Valproate

Clearing sodium valproate, as one of the vital and sensitive medicines, requires strict and complete compliance with regulations and the submission of valid documents. These documents are essential to ensure the quality, authenticity, and safety of the drug; failure to provide any of them can lead to delays in the clearance process or even rejection of the request.

Import permit from the Food and Drug Administration (IFDA): As one of the main required documents, this permit confirms that the medicine is suitable for distribution in Iran’s domestic market. The Food and Drug Administration issues this permit after reviewing the product’s quality and its compliance with health and pharmaceutical standards. Having this permit is a prerequisite for starting the clearance process.
Certificate of Analysis (COA): An official document issued by the manufacturer that indicates the chemical composition, purity, and technical specifications of sodium valproate. This certificate helps confirm the quality of the drug and ensures that the product meets the specified standards.
GMP (Good Manufacturing Practice) Certificate: This certificate indicates adherence to good and hygienic manufacturing practices in the production process. It confirms that the manufacturer has complied with international standards and that all stages of production have been carried out under strict health and quality supervision. Possessing this certificate is considered vital for importing medicines.
Commercial Invoice: As a financial document, it includes important information such as the names and details of the seller and buyer, price, payment terms, and goods details. This document helps customs determine and review the value of the goods during clearance.
Packing List: Includes details related to the number of packages, net and gross weight, and package dimensions. This information is necessary for accurate inspection of goods at customs and helps facilitate the clearance process.
Health and Hygiene Certificate: Confirms that the product is hygienically suitable and produced in accordance with international health standards. This certificate is very important to ensure the safety of imported medicines.
Transport Documents: These include the Bill of Lading or Air Waybill, which record information related to the transportation of the goods. These documents are essential for tracking the shipment and confirming delivery of the goods to customs.
Importer Identification Documents: Identification documents such as a copy of the national ID card or birth certificate and the importer’s business permits must be presented to customs. These documents are necessary to verify the importer’s identity and legal eligibility.
Certificate of Origin/Authenticity: Issued by the supplier or manufacturer, this certificate helps confirm the authenticity of the product. It is especially important for medicines considered sensitive goods.
Documents Related to Storage Conditions: If sodium valproate requires specific storage conditions, documents related to these conditions must also be provided. This information includes temperature, humidity, and other environmental conditions for proper storage of the medicine. Collecting and providing all these documents in the clearance process for sodium valproate is vital. The absence of any of these documents may lead to delays in clearance and delivery of the medicine to the market, ultimately negatively affecting patients’ access to this essential drug. Therefore, to ensure fast and hassle-free clearance, attention to detail in preparing and organizing the necessary documents is mandatory.

Need to obtain an IFDA permit, determine the HS Code, and prepare pharmaceutical documents? Our team manages the case end-to-end.

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Frequently Asked Questions

What is the HS Code for Sodium Valproate?

According to the text, sodium valproate can be declared under HS 3003 (medicaments not in measured doses) or HS 3004 (medicaments in measured doses and packaged for retail sale), depending on the presentation; final determination depends on packaging and use.

What permits are required for import?

Permits from the Iran Food and Drug Administration (IFDA) confirming quality and authenticity, along with a COA from the manufacturer and a valid GMP certificate. Without these permits, the import is not legal and the clearance process will encounter problems.

What are the transport and storage conditions for sodium valproate?

Transport at a controlled temperature, full labeling of packages, and recording precise pharmaceutical specifications; any deficiency can damage the drug and cause bodily/financial loss.

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Summary & Call to Action

By using these specialized services, clients can benefit from fast and hassle-free clearance of sodium valproate.

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Special Customs Clearance Services by Saba Brokerage

Saba Brokerage is one of the leading customs brokers in Iran that, with its experience and specialized knowledge in clearing medicines and pharmaceutical substances, provides comprehensive services to facilitate the clearance process of sodium valproate. Some of this brokerage’s special services in the field of clearing pharmaceutical goods include:

Rapid acquisition of required permits: With its extensive relationships with governmental organizations and regulatory bodies, this brokerage can obtain the necessary permits from the Food and Drug Administration and the Ministry of Health in the shortest possible time. This significantly accelerates the drug clearance process and ensures timely supply to the market.
Specialized customs and health consulting: A team of expert consultants accompanies clients through all import stages, from order registration to final delivery of the goods. These services are particularly effective for pharmaceutical substances that require special permits and health inspections.
Complete management of the clearance process: By comprehensively managing all customs stages including inspection of goods, submission of documents to customs, and obtaining the necessary permits this brokerage optimizes the clearance process and prevents unnecessary delays.
Provision of reliable warehousing and transport services: In addition, warehousing services for medicines are provided in facilities under controlled hygienic conditions, and the transport of medicines is guaranteed to be standard and under controlled conditions.
Preservation of drug quality and authenticity: By strictly adhering to all health and customs regulations and standards, this brokerage ensures that cleared medicines are delivered to their final destination in the best possible condition.

With experience and expertise in clearing medicines, it can assure its clients that all stages of import and clearance of sensitive drugs such as sodium valproate will be carried out with high precision and efficiency.

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