Key Documentation for Importing Pharmaceutical Products into Oman

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 the Port of Sohar, Oman (or other approved Omani ports).

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. Often required to determine applicable customs duties and eligibility for preferential trade agreements.

Import License / Oman Ministry of Health (MOH) Authorization

Pharmaceutical products and medical devices generally require prior import approval, registration, or authorization from the Oman Ministry of Health (MOH) before entering the country.

Customs Declaration

Formal declaration submitted to Oman Customs, providing comprehensive details of the imported pharmaceutical goods, their value, origin, and classification.

Product Registration Dossier

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

Good Manufacturing Practice (GMP) Certificates

Issued by the competent health authority in the country of origin, confirming that the pharmaceutical products are manufactured in compliance with international 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 Oman Customs Tariff, determining applicable customs duties, VAT, and statistical reporting requirements.

Pro-forma Invoice

Used for preliminary regulatory reviews, MOH approvals, and initial commercial arrangements, especially for trial shipments or tender-based procurement.

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 active pharmaceutical ingredients (APIs), chemicals, or hazardous 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 clearance.

Import Duties and Taxes Payment

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

---

Compliance and Regulatory Requirements for Pharmaceutical Imports into Oman

Registration with Oman Customs

Importers must be registered with Oman Customs and hold a valid commercial registration (CR) issued in Oman.

Oman MOH Product Registration and Compliance

All pharmaceutical products must be registered and approved by the Oman Ministry of Health. This includes compliance with regulations on product safety, efficacy, labeling (Arabic requirements), shelf life, and packaging standards.

Controlled Medicines and Narcotic Permits

Special permits are mandatory for importing controlled drugs, psychotropics, or narcotics, in strict accordance with Oman MOH and international conventions.

Engage with a Licensed Customs Broker

Due to the strict regulatory framework governing pharmaceutical imports in Oman, working with a licensed local customs broker experienced in MOH approvals, cold chain logistics, and Oman Customs procedures is critical for efficient and compliant clearance.

Commercial Invoice (for Pharmaceutical Products)

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 Oman.
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: Include 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: Use 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, OMR, etc.).

Terms of Sale (Incoterms)

E.g., CIF Port of Sohar, Oman, FOB New York — defining cost and risk allocation.

Shipping and Delivery Information

Port of Loading/Destination: E.g., New York → Port of Sohar, Oman.
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.

---

Bill of Lading (BOL) for Pharmaceutical Products

Shipper Information

Full name and address of the exporter or freight forwarder.

Consignee Information

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

Carrier Information

Name: Shipping line or logistics provider.
Transport Mode: Air or sea carrier, including flight or vessel details.

Description of Goods

Use clear, regulatory-compliant descriptions such as “paracetamol tablets,” “insulin vials,” or “COVID-19 diagnostic kits,” consistent with the commercial invoice and Oman MOH registrations.

Gross Weight and Dimensions

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

Freight Charges

Charge Terms: Indicate prepaid or collect, and clearly identify the responsible party.

BOL Number

Unique reference number used for shipment tracking.

Date of Shipment

Date the goods were physically dispatched.

Terms and Conditions

Include liability clauses, applicable international conventions (e.g., Hague-Visby Rules for sea freight, Montreal Convention for air freight), and cold chain maintenance responsibilities when applicable.

---

Packing List (for Pharmaceutical Products)

Exporter and Consignee Information

Must match exactly with the commercial invoice and BOL.

Shipment Details

Include invoice number, BOL number, and shipment date.

Itemized Contents

Detailed list showing product name, dosage form, batch/lot number, expiration date, and packaging description.

Quantities and Packaging Type

Specify 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

Include gross weight, net weight, and total shipment volume.

---

Certificate of Origin (for Pharmaceutical Products)

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 certification body, as required for Oman Customs clearance.

---

Key Considerations for Pharmaceutical Imports into Oman

Technical Accuracy

Ensure product descriptions align exactly with Oman Ministry of Health (MOH) registrations, batch certificates, and packaging labels to avoid clearance delays.

Regulatory Compliance

All pharmaceutical products must comply with Oman MOH requirements for product registration, import licensing, labeling, shelf life, and packaging.
Controlled medicines and psychotropic substances require special permits.

Cold Chain and Handling

Temperature-sensitive pharmaceuticals must include:

• Validated thermal packaging

• Real-time temperature monitoring devices

• Cold chain logs and standard operating procedures (SOPs)

Language Requirements

English documentation is generally accepted; Arabic labeling or documentation may be required for MOH review, customs clearance, or retail distribution.

Work with Experts

Engage a licensed Omani customs broker and regulatory consultant experienced in Oman MOH procedures, cold chain logistics, and Port of Sohar operations to ensure smooth, compliant importation.