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Customs Clearance for Hormones

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Hormone Customs Clearance | HS Code, Documents & Permits Clearance of hormones from Iranian customs

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

Hormone customs clearance Clearing hormones from customs is one of the most complex and sensitive clearance processes in the field of pharmaceutical and chemical goods. Due to their key role in regulating the body’s biological functions and their high importance across various fields including medicine, veterinary medicine, and biotechnology, hormones require greater diligence and sensitivity during import and export stages. These products which include a category of vital chemical and pharmaceutical substances are subject to strict international and domestic regulations because of their medical and economic importance.

To estimate the time and cost of hormone clearance, contact the experts at Saba Tarkhis.

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1) Applications of Hormones

Applications of hormones Hormones are chemical messengers produced by the endocrine glands that help regulate various body functions, including metabolism, growth, reproduction, and homeostasis. Each group of hormones has specific applications in the pharmaceutical and medical industries:
Treatment of hormonal disorders: including hormones such as insulin to control blood sugar in diabetic patients, or thyroid hormones for treating thyroid deficiencies.
Immune system support: hormones play an important role in boosting the immune system and are used in treating cancer patients and those with autoimmune diseases.
Control of reproduction and growth: hormones such as growth hormone and sex hormones used to treat growth problems and reproductive abnormalities.

2) HS Code (Customs Tariff) for Hormones

TThe customs tariff for hormones falls under several HS codes, each differing based on the type and application of the hormones. Below are some of the most important tariff codes for various hormones along with their uses:
Steroid hormones and their derivatives (HS Code 2937):
Sex hormones (Estrogen, Progesterone): These hormones are used as hormone replacement therapies for menopausal women and to treat reproductive disorders.
Adrenal-related hormones (Cortisol, Aldosterone): These hormones play a role in stress control and blood pressure regulation and are used to treat adrenal insufficiencies.

Heterocyclic compounds with hormonal function (HS Code 2934):
Insulin: used as the primary hormone for regulating blood sugar in diabetic patients. Insulin, as one of the most sensitive pharmaceutical products, requires temperature-controlled transport and storage.
Growth Hormone (GH): used in treating growth deficiencies, short stature, and improving muscle mass in specific patients.

Peptide and protein hormones (HS Code 3002):
Oxytocin: a hormone used to stimulate uterine contractions during childbirth and to facilitate labor.
Prolactin: this hormone is used to stimulate milk production after childbirth and to treat issues related to lactation in women.

Thyroid hormones (HS Code 2937):
Thyroxine: a thyroid hormone used to regulate metabolism and treat thyroid insufficiencies and hypothyroidism.

Synthetic sex hormones (HS Code 2937):
Testosterone: as the male sex hormone, used to treat male reproductive insufficiencies and conditions related to decreased testosterone levels.

Glycoprotein hormones (HS Code 2934):
Luteinizing hormone (LH) and Follicle-stimulating hormone (FSH): used to manage and treat infertility and to regulate ovulation.

Hormone Group Examples/Use HS Code
Steroid/Sex Estrogen, Progesterone, Testosterone; HRT/infertility treatment 2937
Adrenal Cortisol, Aldosterone; adrenal insufficiency/blood pressure 2937
Heterocyclic with hormonal function Insulin, GH; diabetes/growth disorders 2934
Peptide/Protein (preparations) Oxytocin, Prolactin; labor/lactation 3002
Thyroid Thyroxine; metabolic disorders/hypothyroidism 2937
Glycoprotein LH, FSH; infertility treatment/ovulation regulation 2934

Note: The final heading may vary based on form of entry (active substance, finished preparation), biological origin, and formulation; for finished dosage forms, Chapter 3002/3004 applies as appropriate.

3) Special Conditions for Import and Export of Hormones

Special conditions for the import and export of hormones Due to the high sensitivity of these substances, importing and exporting hormones requires special conditions in terms of transportation, storage, and legal permits. As biological and pharmaceutical products, hormones must comply with strict domestic and international regulations. These special conditions help importers and exporters deliver these substances properly to their destinations while maintaining quality and safety.

4) Conditions for Importing Hormones into Iran

Iran, as one of the largest importers of hormones in the Middle East, imports a significant volume of these products for use in the medical and pharmaceutical industries. The most important conditions for importing hormones into Iran are as follows:
Obtaining permits from the Food and Drug Administration (IFDA): All hormone imports require permits from the Food and Drug Administration. These permits are issued to confirm the quality, authenticity, and safety of imported hormones. Each type of imported hormone must comply with this organization’s standards.

Special transportation conditions: Many hormones require transport at controlled temperatures. For example, insulin and other peptide hormones must be transported at low temperatures (between 2 to 8 °C) to prevent degradation or reduced efficacy. Specialized temperature-controlled packaging is essential for these hormones.

Health and quality certificates: Importing hormones requires health certificates from reputable international authorities. These certificates ensure product quality and authenticity and must be approved before entry into the country.

5) Exports and Volume of Hormone Imports/Exports

Export of hormones from Iran Although Iran is better known as an importer of hormones, in recent years some domestic pharmaceutical companies have managed to produce certain hormones. Exports of these products to neighboring and developing countries such as Afghanistan and Iraq are increasing. Volume of hormone imports and exports to Iran Imports of hormones into Iran have steadily increased in recent years due to growing medical needs and the rise in patients requiring hormonal therapies, especially in the areas of diabetes and thyroid problems. For example, the volume of insulin imports into Iran is among the highest within pharmaceuticals. On the export side, the production of certain hormones in Iran has not yet reached large volumes, and exports remain limited. However, with the growth of the pharmaceutical industry in the future, Iran may become one of the smaller exporters of hormones in the region.

6) Global Circulation of Hormones and Key Players

Global circulation of hormones The global hormone market is one of the largest and most dynamic pharmaceutical markets. Due to their wide applications in treating various diseases—including diabetes, thyroid disorders, and growth and reproductive insufficiencies—hormones are in high demand. The global financial turnover of hormones reaches billions of dollars and their trade volume grows significantly each year.

Hormone-exporting countries The largest hormone-exporting countries in the world include the following:
United States: the largest producer and exporter of peptide, protein, and steroid hormones. Owing to advanced biotechnologies, this country produces very high-quality products.
Germany: one of the largest producers of steroid and sex hormones in the world, playing a major role in exports to Europe and Asia.
Switzerland: a leader in producing highly precise hormones for medical uses with a very powerful pharmaceutical industry.
Japan: thanks to advanced pharmaceutical companies and strong R&D, Japan is one of the largest exporters of growth and thyroid hormones.
Hormone-importing countries Among the importers of hormones are:
China: as the largest importer of pharmaceutical products, including hormones, due to its large population and increasing medical needs. Iran: as mentioned, Iran is one of the major importers of therapeutic hormones, especially insulin and growth hormones.
India: with rapid growth in the medical and pharmaceutical sectors, India is also one of the major importers of hormones.

7) Required Documents for Hormone Customs Clearance

Required documents for clearing hormones Due to their high sensitivity and vital applications in medical and pharmaceutical industries, clearing hormones requires accurate and credible documentation. These documents must guarantee product quality and authenticity and comply with all legal and health requirements.
1. Food and Drug Administration permit
The first and most important document for importing hormones is the permit from the Food and Drug Administration. This permit indicates that the imported hormones have been reviewed and approved for quality and safety. Without this permit, importing hormones is not possible.

2. Health and quality certificate from the country of origin
Issued by health authorities in the producing country, this certificate guarantees that imported hormones are manufactured according to health and quality standards. It must be issued by reputable authorities internationally recognized by Iran.

3. Commercial Invoice
The commercial invoice includes information such as hormone type, quantity, price, and seller/buyer details. It must be prepared carefully and show all details of the imported goods.

4. Packing List
The packing list includes information on the number of packages, the weight of each package, and the method of packaging. It is required to reconcile imported goods with the commercial invoice.

5. Bill of Lading
This document includes transport specifications for the hormones. It contains information such as the type of goods, transport conditions (e.g., storage temperature), and details of the consignor and consignee.

6. Quarantine certificate (if required)
For certain hormones requiring specific storage conditions, a quarantine certificate is necessary. It indicates compliance with health standards during transport.

7. Certificate of Origin
This certificate confirms that the imported hormones were produced in the country of origin and that their authenticity is guaranteed. It is important for compliance with international trade regulations.

8. Certificate of Analysis (COA)
The COA shows that the hormones have undergone necessary testing and that their composition and purity meet pharmaceutical standards. It helps ensure product quality.

9. Temperature Control Certificate
Many hormones require storage at specific temperatures. This certificate shows that correct storage temperatures were maintained during transport, preventing product spoilage.

10. Insurance Certificate
To protect the financial value of hormones during transport, insurance is essential. This certificate demonstrates insurance coverage for imported goods and assures the importer that, in case of any damage, the goods are covered.

11. Conformity Certificate
This certificate confirms that the imported hormones are produced in accordance with domestic and international standards and pose no issues regarding quality and authenticity.

12. Customs Declaration
The customs declaration specifies the goods, their quantity, and value for submission to customs. It is one of the principal documents in the clearance process and must be completed carefully and fully.

Need precise HS determination and a path for obtaining IFDA permits? Our team manages the case end-to-end.

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Frequently Asked Questions

Under which HS Codes are hormones declared?

Depending on type and origin: steroid/thyroid mainly 2937, heterocyclic compounds with hormonal function 2934, and peptide/biologic finished preparations often under 3002 (and, as applicable, 3004).

What are the transport conditions for hormones?

Many hormones (e.g., insulin) require controlled temperature 2–8 °C, insulated packaging, and temperature logging to prevent degradation and loss of efficacy.

Which permits and documents are required for import?

Permit from the Food and Drug Administration, health/quality certificates, COA, certificate of origin, insurance, bill of lading stating temperature conditions, and a complete customs declaration are key documents.

Multimedia Suggestions

  • Image file name: hormones-customs-clearance-iran.jpg
  • Alt Text: Hormone customs clearance in Iran | HS 2934, 2937, 3002
  • Caption: «From HS determination to IFDA permit and cold-chain transport: hormones clearance checklist»
  • Infographic: «Permit pathway, documents (COA/BL/Insurance) and transport temperature control»

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Summary & Call to Action

Hormone clearance cases—due to biological sensitivity—require precise HS determination, obtaining IFDA permits, cold-chain transport, and complete documentation. Saba Tarkhis executes the entire process swiftly and in full compliance.

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Saba Brokerage’s Special Services for Hormone Clearance

In the field of clearing pharmaceutical and sensitive materials, specialized and professional services help importers complete the clearance process with minimal hassle and cost. For importing hormones—which require diligence and adherence to special conditions—these services include the following:

  • Expedited acquisition of required permits: leveraging experience and extensive ties with relevant organizations, permits such as IFDA approvals and health certificates are obtained quickly and cost-effectively.
  • Controlled transport and packaging: due to the need to store hormones at specific temperatures, cooperation with reputable logistics providers ensures delivery under optimal conditions and preservation of initial quality.
  • Reducing clearance costs: by optimizing clearance processes and employing smart solutions, importers can reduce extra costs and clear their goods in the shortest possible time.
  • Continuous follow-up and full support: from the moment goods enter customs until final delivery, the specialized team follows all stages and keeps importers informed to prevent any delays or problems.
  • Specialized consulting: guidance on documents, permits, and transport conditions helps importers complete the clearance process correctly and without issues.

These specialized services make hormone clearance faster, more efficient, and less costly, preventing potential delays and issues.

Contact our experts for more information.

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