Key Documentation for Importing Pharmaceutical Products into Saudi Arabia

Commercial Invoice

A detailed invoice outlining the transaction, including buyer and seller information, full description of the pharmaceutical products (e.g., medicines, APIs, medical devices), quantities, HS codes, and declared value.

Bill of Lading (BOL)

A legal transport document between shipper and carrier detailing the type, quantity, and final destination of the pharmaceutical goods, typically routed via Jeddah Islamic Port or King Abdulaziz Port (Dammam), or via approved Saudi airports.

Packing List

An itemized list of all cargo, including packaging formats (e.g., blister packs, vials, pallets), lot numbers, batch codes, dimensions, gross and net weights, and packaging details — essential for customs and regulatory clearance.

Certificate of Origin

Confirms the country of manufacture of the products. Required to determine applicable customs duties and eligibility for preferential trade agreements under Saudi Customs regulations.

Import License / Saudi Food & Drug Authority (SFDA) Authorization

Pharmaceutical products and medical devices generally require prior import approval, registration, or authorization from the Saudi Food & Drug Authority (SFDA) before entry into the Kingdom.

Customs Declaration

Formal declaration submitted to Saudi Customs (ZATCA), providing comprehensive details of the imported pharmaceutical goods, including value, origin, and HS classification.

Product Registration Dossier

Documentation covering product formulation, manufacturing process, quality control, safety, and efficacy — mandatory for medicinal products regulated by the SFDA.

Good Manufacturing Practice (GMP) Certificates

Issued by the competent health authority in the country of origin, confirming that pharmaceutical products are manufactured in compliance with internationally recognized GMP standards.

Insurance Certificate

Proof of cargo insurance covering the shipment, particularly important for high-value, fragile, or temperature-sensitive pharmaceutical products.

Harmonized System (HS) Codes

Accurate HS classification under the Saudi Customs Tariff, determining applicable customs duties, VAT, and statistical reporting requirements.

Pro-forma Invoice

Used for preliminary regulatory reviews, SFDA approvals, tenders, and initial commercial arrangements, especially for trial shipments or pre-approval processes.

Cold Chain and Temperature Control Documentation

Mandatory for vaccines, biologics, and other temperature-sensitive pharmaceuticals. Includes temperature logs, data logger reports, real-time monitoring records, and packaging specifications (e.g., insulated or active containers).

Safety Data Sheets (SDS)

Required for certain APIs, chemicals, or hazardous pharmaceutical components to ensure safe handling during transportation, storage, and customs inspections.

Letter of Credit or Payment Terms Agreement

Defines international payment terms between buyer and seller and may be required by banks or authorities to authorize cargo release.

Import Duties and Taxes Payment

Evidence of payment or confirmation of applicable customs duties, VAT, customs fees, and any other levies imposed on pharmaceutical imports into Saudi Arabia.

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Compliance and Regulatory Requirements for Pharmaceutical Imports into Saudi Arabia

Registration with Saudi Customs (ZATCA)

Importers must be registered with ZATCA and hold a valid Commercial Registration (CR) issued in Saudi Arabia.

SFDA Product Registration and Compliance

All pharmaceutical products must be registered and approved by the Saudi Food & Drug Authority (SFDA). This includes compliance with regulations covering:

• Product safety, quality, and efficacy

• Arabic labeling requirements

• Shelf life, batch traceability, and serialization

• Packaging, tamper evidence, and anti-counterfeiting measures

Controlled Medicines and Narcotic Permits

Special permits are mandatory for importing controlled drugs, psychotropics, or narcotics, in strict compliance with SFDA regulations and international drug control conventions.

Engage with a Licensed Customs Broker

Due to Saudi Arabia’s strict regulatory framework governing pharmaceutical imports, working with a licensed Saudi customs broker experienced in SFDA approvals, cold chain logistics, and ZATCA clearance procedures is critical for efficient and compliant import operations.

Commercial Invoice (for Pharmaceutical Products – Saudi Arabia)

Exporter Information

Name and Address: Full legal name and registered address of the pharmaceutical manufacturer/exporter.
Contact Details: Phone number, email, and fax (if applicable).

Importer Information

Name and Address: Legal name and registered location of the pharmaceutical distributor, importer, or healthcare provider in Saudi Arabia.
Contact Details: Email and phone number for local coordination.

Invoice Number and Date

Invoice Number: Unique reference number for tracking and recordkeeping.
Date of Issue: Date the invoice was generated.

Purchase Order Number

Reference Number: Buyer’s purchase order number for procurement tracking.

Description of Goods

Detailed Description: Product names, dosage form (e.g., tablets, vials, syringes), strength/concentration, batch/lot numbers, expiry dates, and therapeutic category (e.g., antibiotic, vaccine, analgesic).
HS Codes: Correct Harmonized System codes (e.g., 3004.90 for prepared medicines, 3002.20 for vaccines).

Quantity and Unit of Measure

Quantity: Number of units per product (e.g., boxes, bottles, kits).
Unit: Tablets, vials, syringes, cartons, etc.

Unit Price and Total Price

Unit Price: Price per unit.
Total Price: Line-item totals and overall invoice value.

Currency

Type: Clearly stated (USD, EUR, SAR, etc.).

Terms of Sale (Incoterms)

Examples: CIF Jeddah Islamic Port, Saudi Arabia, CIF King Abdulaziz Port (Dammam), FOB New York — defining cost and risk allocation.

Shipping and Delivery Information

Port of Loading/Destination: E.g., New York → Jeddah Islamic Port, Saudi Arabia.
Estimated Shipping Date: Projected departure date.

Payment Terms

Method: Letter of Credit (L/C), Telegraphic Transfer (TT), Net-30, as per the sales contract.

Signature

Authorized Representative: Signature and printed name of the seller/exporter representative.

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Bill of Lading (BOL) for Pharmaceutical Products – Saudi Arabia

Shipper Information

Full name and address of the exporter or freight forwarder.

Consignee Information

Full details of the Saudi importer or their designated licensed Saudi customs broker.

Carrier Information

Name: Shipping line or airline.
Transport Mode: Air or sea, including flight or vessel details.

Description of Goods

Regulatory-compliant descriptions such as “paracetamol tablets,” “insulin vials,” “COVID-19 diagnostic kits”, consistent with the commercial invoice and Saudi Food and Drug Authority (SFDA) registrations.

Gross Weight and Dimensions

Accurate total weight and volume per pallet or package, especially for temperature-sensitive pharmaceutical products.

Freight Charges

Charge Terms: Prepaid or collect, clearly identifying the responsible party.

BOL Number

Unique reference number for shipment tracking.

Date of Shipment

Date the goods were physically dispatched.

Terms and Conditions

Include liability clauses, applicable conventions (Hague-Visby Rules for sea freight, Montreal Convention for air freight), and cold chain responsibilities where applicable.

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Packing List (for Pharmaceutical Products – Saudi Arabia)

Exporter and Consignee Information

Must exactly match the commercial invoice and BOL.

Shipment Details

Invoice number, BOL number, and shipment date.

Itemized Contents

Product name, dosage form, batch/lot number, expiration date, and packaging description.

Quantities and Packaging Type

Number of packs, blister cards, cartons, pallets, and container types (e.g., insulated shippers, active containers, dry ice units).

Package Identification

Clearly labeled packages such as:
“BOX 1/20 – VACCINE – KEEP REFRIGERATED”

Total Weight and Volume

Gross weight, net weight, and total shipment volume.

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Certificate of Origin (for Pharmaceutical Products – Saudi Arabia)

Exporter and Consignee

Full legal names and addresses of both parties.

Goods Description

Product names, HS codes, dosage forms, and intended use (human or veterinary).

Origin Criterion

Country of manufacture (e.g., “Manufactured in Germany”).

Certification

Signed and stamped by the relevant Chamber of Commerce or authorized body, as required for Saudi Customs (ZATCA) clearance.

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Key Considerations for Pharmaceutical Imports into Saudi Arabia

Technical Accuracy

Product descriptions must match SFDA product registrations, batch certificates, and labeling to avoid customs or regulatory delays.

Regulatory Compliance

All pharmaceutical products must comply with Saudi Food and Drug Authority (SFDA) requirements, including:

• Product registration and import permits

• Arabic labeling (mandatory)

• Shelf life compliance and batch traceability

• Packaging, serialization, and barcoding (where applicable)

Controlled drugs, narcotics, and psychotropics require special SFDA permits and approvals.

Cold Chain and Handling

Temperature-sensitive pharmaceuticals must include:

• Validated thermal packaging

• Temperature data loggers

• Cold chain monitoring reports

• SOPs compliant with SFDA guidelines

Language Requirements

• Commercial documentation: English accepted

• Product labeling: Arabic mandatory

• Additional Arabic documents may be required for SFDA and customs clearance

Work with Experts

Engage a licensed Saudi customs broker and regulatory consultant experienced with:

• SFDA approvals

• ZATCA customs procedures

• Pharmaceutical cold chain logistics

• Operations at Jeddah Islamic Port, King Abdulaziz Port (Dammam), and major Saudi airports