Key Documentation for Importing Pharmaceutical Products into Colombia

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 Colombia.

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 those involving the Pacific Alliance or CAN (Andean Community).

Import License / INVIMA Authorization
All pharmaceutical products and medical devices generally require prior import approval from INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos). This involves registration in the VUCE (Ventanilla Única de Comercio Exterior) system and compliance with national health and safety regulations.

Customs Declaration (Declaración de Importación)
Formal submission to DIAN (Dirección de Impuestos y Aduanas Nacionales), providing detailed information for fiscal and regulatory validation of the import.

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

Good Manufacturing Practice (GMP) Certificates
Issued by a recognized health authority in the country of origin, confirming compliance with international GMP standards. INVIMA may request inspection reports or certificates from the manufacturer’s national regulatory body.

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

Harmonized System (HS) Codes
Correct classification of products under the Colombian Tariff Schedule (based on HS codes) is necessary to determine import duties and VAT.

Pro-forma Invoice
Used during early procurement, tendering, or regulatory approval stages, especially for public health procurement or controlled imports.

Cold Chain and Temperature Control Documentation
Required for temperature-sensitive products such as vaccines, biologics, and certain injectables. Includes real-time temperature logs, packaging validation reports, and cold chain handling instructions in line with INVIMA’s requirements.

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

Letter of Credit or Payment Terms Agreement
Defines agreed international payment terms between buyer and seller. Often required by Colombian customs and financial institutions for final cargo release.

Import Duties and Taxes Payment
Receipts or confirmations of payment for applicable Import Duty, VAT (IVA), and other fees must be submitted to clear the goods through DIAN.

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Compliance and Regulatory Requirements for Pharmaceutical Imports into Colombia

Registration with DIAN (Dirección de Impuestos y Aduanas Nacionales)
Importers must be registered with DIAN and authorized to operate within Colombia’s customs and foreign trade systems, including access to the VUCE platform.

INVIMA Product Registration and Approval
Most pharmaceuticals and medical devices must be registered with INVIMA. This includes dossier submission, GMP compliance, stability data, Spanish-language labeling, and the appointment of a local sanitary representative (titular sanitario).

Controlled Substances and Narcotics Permits
For products classified as psychotropics, narcotics, or precursors, special permits and import quotas must be approved by INVIMA and Fondo Nacional de Estupefacientes, in compliance with Colombian Law 30 of 1986 and other national regulations.

Work with a Licensed Customs Broker (Agente de Aduanas)
Due to the complexity of Colombia’s regulatory environment, it is highly advisable to work with a licensed customs broker experienced in pharmaceutical and healthcare imports.

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 Colombia.
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 Colombia’s customs tariff (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, etc.).

Terms of Sale (Incoterms)
E.g., CIF Cartagena, FOB Hamburg — defines cost and risk allocation. Common Colombian ports include Cartagena, Buenaventura, and Barranquilla.

Shipping and Delivery Info
Port of Loading/Destination: E.g., Toronto → Cartagena → Bogotá.
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 Colombian 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 Colombia

Technical Accuracy
Ensure all product information aligns with INVIMA product registrations, certificates of analysis, and packaging. Discrepancies may result in customs delays or rejection.

Regulatory Compliance
All pharmaceuticals must be registered and approved by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos).
Comply with Colombian labeling standards (Spanish required), expiration date policies, and traceability regulations (e.g., UDI or serial codes when applicable).

Controlled Substances and Special Permits
Controlled drugs, narcotics, and precursors require prior authorization from INVIMA and the Fondo Nacional de Estupefacientes, in compliance with Colombia’s drug control laws (e.g., Law 30 of 1986).

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 INVIMA and DIAN.

Work with Experts
Partner with a licensed Colombian customs broker (Agente de Aduanas) and a regulatory consultant experienced with INVIMA and VUCE to ensure compliance, avoid delays, and maintain cold chain integrity.