Key Documentation for Importing Pharmaceutical Products into the Dominican Republic

Commercial Invoice
A detailed invoice outlining the transaction, including buyer/seller information, complete description of pharmaceutical products (e.g., medicines, APIs, medical devices), quantities, unit values, and declared total value.

Bill of Lading (BOL)
A legal transport document issued by the carrier, listing the type, quantity, and final destination of the pharmaceutical goods being shipped to the Dominican Republic.

Packing List
An itemized list detailing each product’s packaging format (e.g., blister packs, vials, cartons, pallets), lot numbers, batch codes, dimensions, and gross/net weights — essential for customs inspection and clearance.

Certificate of Origin
Verifies the country of manufacture for the goods. Often required to apply for reduced duties under free trade agreements such as DR-CAFTA or CARICOM.

Import License / Authorization from DIGEMAPS
Pharmaceutical products and medical devices require prior approval from DIGEMAPS (Dirección General de Medicamentos, Alimentos y Productos Sanitarios), a division of the Ministry of Public Health (Ministerio de Salud Pública – MSP). Approval is necessary for both commercial and humanitarian imports.

Customs Declaration (Declaración Única Aduanera – DUA)
Formal submission to DGA (Dirección General de Aduanas), providing detailed information for fiscal and regulatory validation of the import.

Product Registration Dossier
Documentation covering the product’s composition, therapeutic purpose, manufacturing process, quality controls, clinical data, labeling, and safety profile. Required by DIGEMAPS for medicines and medical devices.

Good Manufacturing Practice (GMP) Certificates
Issued by a competent health authority in the country of origin. The Dominican Republic requires evidence of GMP compliance as part of product registration or import approval processes.

Insurance Certificate
Proof of insurance coverage for the shipment, especially important for high-value, perishable, or sensitive pharmaceutical products (e.g., vaccines, biologics, specialty injectables).

Harmonized System (HS) Codes
Correct classification of products under the Dominican Tariff Schedule (based on WCO HS codes) is necessary for determining import duties and VAT.

Pro-forma Invoice
Used in procurement or regulatory processes, especially when applying for permits or approvals in advance of shipment, common in public sector or humanitarian imports.

Cold Chain and Temperature Control Documentation
Mandatory for temperature-sensitive products like biologics and vaccines. Includes real-time temperature logs, packaging validation reports, and cold chain handling SOPs, as required by DIGEMAPS.

Pharmacovigilance or Safety Data Sheets (SDS)
Mandatory for APIs, excipients, or hazardous substances. SDS must be in Spanish, detailing handling, storage, hazard classification, and emergency response protocols.

Letter of Credit or Payment Terms Agreement
Defines agreed international payment terms between buyer and seller. Often requested by financial institutions or customs as part of cargo release requirements.

Import Duties and Taxes Payment
Proof of payment for applicable import duties, ITBIS (VAT), and any special fees. Necessary to release goods from customs clearance by DGA.

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Compliance and Regulatory Requirements for Pharmaceutical Imports into the Dominican Republic

Registration with DGA (Dirección General de Aduanas)
Importers must be registered with DGA and comply with customs formalities, including use of the DUA system and authorized customs brokers.

DIGEMAPS Product Registration and Authorization
All pharmaceutical products and medical devices must be approved by DIGEMAPS under the Ministry of Public Health. Requirements include a complete technical dossier, GMP certification, Spanish-language labeling, shelf life data, and local representation.

Controlled Substances and Special Permits
Products classified as controlled substances (e.g., narcotics, psychotropics, or chemical precursors) require special authorization from MSP and other relevant authorities, in compliance with Dominican laws and international drug control conventions.

Work with a Licensed Customs Broker (Agente de Aduanas)
Due to the complexity of the Dominican Republic’s import regulations, working with a licensed customs broker and a regulatory expert in health products is highly recommended to avoid delays, ensure compliance, and maintain cold chain integrity.

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 the Dominican Republic.
Contact Details: Email and phone 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 as per the Dominican Republic’s tariff schedule (based on WCO HS codes), e.g., 3004.90 for 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 total invoice value.

Currency
Type: Clearly stated (USD, EUR, DOP, etc.).

Terms of Sale (Incoterms)
E.g., CIF Caucedo, FOB Miami — defines cost and risk allocation. Common ports in the Dominican Republic include Caucedo, Haina, and Puerto Plata.

Shipping and Delivery Info
Port of Loading/Destination: E.g., Miami → Caucedo → Santo Domingo.
Estimated Shipping Date: Projected departure date.

Payment Terms
Method: L/C, TT, Net-30, per the contract.

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

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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 Dominican importer or their appointed customs broker (Agente de Aduanas).

Carrier Information
Name: Shipping line or logistics provider.
Transport Mode: Specify air or sea; include flight number or vessel name and voyage number.

Description of Goods
Use regulatory and product-specific terms such as “paracetamol tablets,” “insulin vials,” or “COVID-19 test kits,” consistent with the commercial invoice.

Gross Weight and Dimensions
Provide accurate weight and volume per package/pallet — essential for customs and temperature-sensitive cargo.

Freight Charges
Charge Terms: Indicate whether prepaid or collect, and who bears the cost.

BOL Number
Unique reference number for tracking.

Date of Shipment
Date goods were physically dispatched.

Terms and Conditions
Include liability clauses, applicable international conventions (e.g., Warsaw or Montreal for air, Hague-Visby for sea), and cold chain preservation responsibilities.

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Packing List (for Pharmaceutical Products)

Exporter and Consignee Information
Must exactly match the commercial invoice and BOL.

Shipment Details
Include invoice number, BOL number, and shipment date.

Itemized Contents
List product names, dosage forms, batch/lot numbers, expiration dates, and packaging formats.

Quantities and Packaging Type
Include number of units, cartons, pallets, and packaging types (e.g., thermal shippers, dry ice containers).

Package Identification
Clear labels such as: “BOX 1/20 – VACCINE – KEEP REFRIGERATED.”

Total Weight and Volume
Provide gross and net weights and full volume of the shipment.

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Certificate of Origin (for Pharmaceutical Products)

Exporter and Consignee
Full contact information for both parties.

Goods Description
List product names, HS codes, dosage forms, and intended use (e.g., human or veterinary).

Origin Criterion
State country of manufacture (e.g., “Manufactured in Germany”).

Certification
Signed and stamped by a recognized Chamber of Commerce or export authority.

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Key Considerations for Pharmaceutical Imports into the Dominican Republic

Technical Accuracy
Ensure all product information aligns with DIGEMAPS (Dirección General de Medicamentos, Alimentos y Productos Sanitarios) registrations, certificates of analysis, and packaging. Discrepancies may result in customs delays or rejection.

Regulatory Compliance
All pharmaceuticals must be registered and approved by DIGEMAPS, under the Ministry of Public Health (MSP).
Comply with Dominican labeling standards (Spanish required), expiration date policies, and applicable traceability measures.

Controlled Substances and Special Permits
Controlled drugs, narcotics, and precursors require prior authorization from DIGEMAPS and the MSP, in compliance with national laws and international conventions.

Cold Chain and Handling
Temperature-sensitive goods must include:

• Validated thermal packaging

• Continuous temperature monitoring

• Documentation (e.g., SOPs, temperature logs, real-time alerts)

Language Requirements
All key documents — labels, certificates of analysis, SDS, and manuals — must be in Spanish for submission to DIGEMAPS and Dirección General de Aduanas (DGA).

Work with Experts
Partner with a licensed Dominican customs broker (Agente de Aduanas) and a regulatory consultant experienced with DIGEMAPS and customs processes to ensure compliance, avoid delays, and protect product integrity.