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Vaccine Customs Clearance in Iran (HS Code + Documents & Permits)
Vaccine customs clearance importing and clearing vaccines through customs is an extremely sensitive and complex process that plays a vital role in public health supply. Because vaccines are indispensable for preventing epidemics and protecting communities, they are subject to stringent international and domestic oversight and regulations. In this process, strict compliance with all health, customs, and global standards is of paramount importance.
To estimate the time and cost of vaccine clearance (human/veterinary), contact the Saba Tarkhis experts.
Instant & Free Consultation1) Vaccine Applications
Vaccines are recognized as one of the most effective tools in medicine for preventing and controlling the spread of dangerous, communicable diseases. These biological products protect people against various viruses and bacteria including influenza, measles, mumps, hepatitis, yellow fever, COVID-19, polio, diphtheria, and many more. Vaccines play a key role in averting global epidemics, and with ongoing advances in biotechnology, new vaccines to combat emerging viruses continue to be developed.
2) Key Points in Vaccine Customs Clearance
Given how sensitive vaccines are, clearing them through customs requires precision and full awareness of the applicable rules and regulations. Knowing every step and legal requirement is essential for a successful vaccine clearance.
Required Documents:
Import permit from the Ministry of Health and the Food & Drug Organization (FDO): Before any vaccine import, importers must obtain the necessary permits from the Ministry of Health and the FDO. These permits ensure that imported vaccines comply with health and safety standards.
Certificate of Analysis (COA): Issued by the manufacturer, this certificate must verify vaccine quality and integrity. The COA contains detailed information about the vaccine’s composition, manufacturing methods, and quality control test results.
Health Certificate: A Health Certificate from competent health authorities is required to confirm that vaccines have been imported in line with national and international sanitary standards.
Commercial Invoice: This invoice includes precise details about the imported vaccines, such as quantity, type, price, and country of origin.
Bill of Lading (B/L): The B/L indicates the transport conditions and status of the shipment and must include accurate information about the transport mode (sea, air, road), cold-chain status, and storage conditions.
Packing List: The packing list records exact details of package contents, number of vials, vaccine volumes, and packaging method, and must be precisely documented and submitted to customs.
Transport & Cold Chain: Due to their sensitive biological nature, vaccines must be transported under controlled temperatures. Maintaining the cold chain, keeping vaccines between 2 to 8 °C, is essential. Any temperature excursion, even minor, can reduce efficacy or degrade the product. Therefore, continuous temperature monitoring throughout transport and during customs storage is mandatory. Specialized carriers typically use data loggers and precise tracking to ensure conditions remain within range.
HS Codes for Vaccines: For vaccines, HS code 3002.20 related to biological products is used. This globally recognized code is applied at all customs for accurate classification. Importers must ensure the correct HS code is selected, as misclassification can cause clearance delays or legal issues. This code also underpins the calculation of customs duties and import taxes.
Required Documents:
Import permit from the Ministry of Health and the Food & Drug Organization (FDO): Before any vaccine import, importers must obtain the necessary permits from the Ministry of Health and the FDO. These permits ensure that imported vaccines comply with health and safety standards.
Certificate of Analysis (COA): Issued by the manufacturer, this certificate must verify vaccine quality and integrity. The COA contains detailed information about the vaccine’s composition, manufacturing methods, and quality control test results.
Health Certificate: A Health Certificate from competent health authorities is required to confirm that vaccines have been imported in line with national and international sanitary standards.
Commercial Invoice: This invoice includes precise details about the imported vaccines, such as quantity, type, price, and country of origin.
Bill of Lading (B/L): The B/L indicates the transport conditions and status of the shipment and must include accurate information about the transport mode (sea, air, road), cold-chain status, and storage conditions.
Packing List: The packing list records exact details of package contents, number of vials, vaccine volumes, and packaging method, and must be precisely documented and submitted to customs.
Transport & Cold Chain: Due to their sensitive biological nature, vaccines must be transported under controlled temperatures. Maintaining the cold chain, keeping vaccines between 2 to 8 °C, is essential. Any temperature excursion, even minor, can reduce efficacy or degrade the product. Therefore, continuous temperature monitoring throughout transport and during customs storage is mandatory. Specialized carriers typically use data loggers and precise tracking to ensure conditions remain within range.
HS Codes for Vaccines: For vaccines, HS code 3002.20 related to biological products is used. This globally recognized code is applied at all customs for accurate classification. Importers must ensure the correct HS code is selected, as misclassification can cause clearance delays or legal issues. This code also underpins the calculation of customs duties and import taxes.
3) Exporters, Iran’s Imports & Exports
Main global vaccine exporters and suppliers Vaccines are largely sourced from developed countries such as the United States, Germany, the United Kingdom, France, China, and India. With advanced infrastructure for biological and laboratory manufacturing, these countries rank among the largest vaccine producers and exporters. Leading global companies include Pfizer, BioNTech, Moderna, Johnson & Johnson, AstraZeneca, Sinopharm, Sinovac, and the Serum Institute of India.
Vaccine imports to Iran In recent years, Iran has become a major importer of vaccines. Notably during the COVID-19 pandemic, Iran imported vaccines such as Pfizer, AstraZeneca, Sinopharm, and other reputable brands from various countries. At the same time, domestic vaccine development efforts have reduced dependence on imports.
Vaccine exports from Iran With progress in the pharmaceutical industry, Iran has become a regional producer of both veterinary and human vaccines. Iranian-made vaccines are exported to some neighboring countries and developing markets, in compliance with international standards and with the required authorizations from global health bodies.
Import/export volumes During the COVID-19 pandemic, Iran’s vaccine imports increased significantly. Importing vaccines from various countries to control the epidemic was a government and public health priority. Meanwhile, domestic production has reduced the need for certain vaccine imports.
4) Vaccine Types & Tariff (HS) Codes
Because vaccines are crucial for public health and disease prevention, their import/export is tightly regulated. One of the most important steps is selecting the correct tariff classification (HS Code). These global codes categorize and identify goods in customs systems; each vaccine type has a specific code based on its nature and use.
Vaccine types and associated HS codes:
Human vaccines (Vaccines for Human Medicine)
Tariff code: 3002.20
Human vaccines are used to prevent diseases such as influenza, measles, mumps, hepatitis, yellow fever, and COVID-19. They are on the front line of combating epidemics and controlling the spread of viral and bacterial illnesses.
Veterinary vaccines
Tariff code: 3002.30
Veterinary vaccines protect animals against zoonotic and infectious diseases. They are vital for herd health and for preventing animal diseases that may transmit to humans.
Viral vaccines
Tariff code: 3002.20.10
These vaccines provide immunity against viral diseases such as influenza, hepatitis, polio, yellow fever, and more recently, COVID-19. Given the rapid spread of viruses and their public health impacts, viral vaccines are especially critical.
Bacterial vaccines
Tariff code: 3002.20.20
Bacterial vaccines are produced to combat diseases transmitted by bacteria. Examples include diphtheria, tetanus, and pertussis vaccines, which significantly reduce the burden of bacterial diseases.
Combination vaccines
Tariff code: 3002.20.30
Combination vaccines include multiple antigens from viruses and/or bacteria, enabling protection against several diseases in a single shot. For example, DTaP (triple) or pentavalent vaccines (e.g., diphtheria, tetanus, pertussis, hepatitis, and polio) are prominent combination types.
Vaccine types and associated HS codes:
Human vaccines (Vaccines for Human Medicine)
Tariff code: 3002.20
Human vaccines are used to prevent diseases such as influenza, measles, mumps, hepatitis, yellow fever, and COVID-19. They are on the front line of combating epidemics and controlling the spread of viral and bacterial illnesses.
Veterinary vaccines
Tariff code: 3002.30
Veterinary vaccines protect animals against zoonotic and infectious diseases. They are vital for herd health and for preventing animal diseases that may transmit to humans.
Viral vaccines
Tariff code: 3002.20.10
These vaccines provide immunity against viral diseases such as influenza, hepatitis, polio, yellow fever, and more recently, COVID-19. Given the rapid spread of viruses and their public health impacts, viral vaccines are especially critical.
Bacterial vaccines
Tariff code: 3002.20.20
Bacterial vaccines are produced to combat diseases transmitted by bacteria. Examples include diphtheria, tetanus, and pertussis vaccines, which significantly reduce the burden of bacterial diseases.
Combination vaccines
Tariff code: 3002.20.30
Combination vaccines include multiple antigens from viruses and/or bacteria, enabling protection against several diseases in a single shot. For example, DTaP (triple) or pentavalent vaccines (e.g., diphtheria, tetanus, pertussis, hepatitis, and polio) are prominent combination types.
| Vaccine Type | Short Description | HS Code |
|---|---|---|
| Human Vaccines | Human immunization; influenza, measles, hepatitis, COVID-19 | 3002.20 |
| Veterinary Vaccines | Animal immunity; prevention of zoonotic diseases | 3002.30 |
| Viral Vaccines | Immunity against viruses; influenza/polio/yellow fever/COVID-19 | 3002.20.10 |
| Bacterial Vaccines | Immunity against bacteria; diphtheria/tetanus/pertussis | 3002.20.20 |
| Combination Vaccines | Multi-antigen; examples DTaP/pentavalent | 3002.20.30 |
Final classification depends on type (human/veterinary), dosage form, storage conditions, and technical documentation.
Need precise HS coding, permit handling, and cold-chain design? Our team manages your file end-to-end.
Request a Proforma Quote5) Required Documents for Vaccine Customs Clearance
Vaccine clearance is a sensitive, complex process that demands accuracy and awareness of the governing regulations. Preparing and submitting complete, correct documentation is mandatory.
Import permit from the Ministry of Health & Food and Drug Organization
The first and most important document is the import authorization issued by the Ministry of Health and the FDO, confirming that imported vaccines meet required health and quality standards.
Certificate of Analysis (COA)
Issued by the vaccine manufacturer, the COA substantiates the product’s quality and authenticity. It must include detailed information on composition, manufacturing stages, and QC test results.
Health Certificate
Issued by health authorities in the country of origin, this certificate shows the vaccines comply with international sanitary standards.
Commercial Invoice
Includes shipment details such as quantities, types, country of origin, and prices. Customs uses this for duties and taxes assessment.
Bill of Lading (B/L)
Specifies transport details. It must indicate the mode (sea/air/road) and storage conditions during transit.
Packing List
Provides exact packaging information: number of vials, type of packaging, and package dimensions. Accurate recording expedites clearance.
Cold Chain Certificate
Confirms vaccines were stored within the required temperatures during transport and warehousing. Maintaining cold chain is critical; any deviation can damage the product.
Standard Certificate
Some vaccines may require confirmations from organizations such as WHO. These attestations show alignment with global health requirements.
Conformity Certificate
Demonstrates that the vaccines meet all standards required by the destination country, helping prevent clearance issues.
Insurance Certificate
Shows the vaccines are insured during transit, covering risks such as damage or spoilage.
Import permit from the Ministry of Health & Food and Drug Organization
The first and most important document is the import authorization issued by the Ministry of Health and the FDO, confirming that imported vaccines meet required health and quality standards.
Certificate of Analysis (COA)
Issued by the vaccine manufacturer, the COA substantiates the product’s quality and authenticity. It must include detailed information on composition, manufacturing stages, and QC test results.
Health Certificate
Issued by health authorities in the country of origin, this certificate shows the vaccines comply with international sanitary standards.
Commercial Invoice
Includes shipment details such as quantities, types, country of origin, and prices. Customs uses this for duties and taxes assessment.
Bill of Lading (B/L)
Specifies transport details. It must indicate the mode (sea/air/road) and storage conditions during transit.
Packing List
Provides exact packaging information: number of vials, type of packaging, and package dimensions. Accurate recording expedites clearance.
Cold Chain Certificate
Confirms vaccines were stored within the required temperatures during transport and warehousing. Maintaining cold chain is critical; any deviation can damage the product.
Standard Certificate
Some vaccines may require confirmations from organizations such as WHO. These attestations show alignment with global health requirements.
Conformity Certificate
Demonstrates that the vaccines meet all standards required by the destination country, helping prevent clearance issues.
Insurance Certificate
Shows the vaccines are insured during transit, covering risks such as damage or spoilage.
7) Key Tips & Practical Recommendations
- Validate the HS Code against the scientific/pharmaceutical specification sheet and product label.
- Establish cold-chain SOPs and archive temperature-logger data for the entire route.
- Match COA/Health Certificate with batch/lot numbers and expiry dates.
- Pre-coordinate with customs/airport cold storage to prevent temperature excursions.
Frequently Asked Questions
What is the HS Code for human vaccines?
They are generally classified under 3002.20; veterinary vaccines under 3002.30. Viral/bacterial/combination subcategories are determined per the table above.
What is the most critical permit for vaccine clearance?
An import permit from the Ministry of Health & Food and Drug Organization, along with the COA, Health Certificate, and cold-chain documentation.
What happens if temperature is not maintained?
It may lead to loss of efficacy, shipment rejection by authorities, and disposal/return costs.
Multimedia Suggestions
- Image file name:
vaccine-customs-clearance-iran-hs-cold-chain.jpg - Alt Text: Vaccine customs clearance in Iran | HS 3002.20 | Cold chain
- Caption: “Vaccine clearance path from Ministry of Health permits to temperature logger control”
- Infographic: “Document checklist + cold-chain design + common HS errors”
Suggested Links
Summary & Call to Action
Given their biological nature, permit requirements, and the cold chain, vaccine clearance is highly sensitive. With hands-on experience, Saba Tarkhis advances your process safely, swiftly, and in full compliance.
Request Expert Consultation Get a Clearance ProformaSpecialized Vaccine Clearance Services by Saba
Saba Brokerage, a pioneer in clearing pharmaceutical and biological goods in Iran, with a seasoned team versed in all customs and health regulations, is ready to execute vaccine clearance with speed and precision. Our services include:
Specialized customs & health consulting: Up-to-date, precise guidance on rules and procedures for vaccine import and clearance, enabling importers to navigate all stages smoothly.
Obtaining required permits: One major challenge in vaccine import is securing authorizations from health and regulatory bodies. Through our extensive connections, we streamline this process for importers.
Cold-chain management: Vaccines require transport at specific temperatures. We coordinate with carriers and warehouses equipped for cold chain to ensure safety and integrity during clearance.
Continuous follow-up & real-time updates: Our support team tracks every stage and keeps clients informed, so no step in the clearance process is missed.
Facilitating finances & tariffs: With full knowledge of customs tariffs and optimal payment methods, we help minimize duty costs and accelerate financial procedures.
With deep experience in handling sensitive, high-value goods such as vaccines, we enable importers to clear vaccines confidently and deliver them to market in the shortest possible time. Committed to service quality, we always strive to provide the best, most professional solutions.
Contact our experts for more information.
