Key Documentation for Importing Pharmaceutical Products into Chile

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 Chile.

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 bilateral or trade agreements such as those within the Pacific Alliance.

Import License / ISP Chile Authorization
All pharmaceutical products and medical devices generally require prior import approval from ISP Chile (Instituto de Salud Pública) through the Chilean Customs system (DUA) and compliance with local health regulations before customs release.

Customs Declaration
Formal submission to the Servicio Nacional de Aduanas (Chilean Customs), 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 ISP Chile.

Good Manufacturing Practice (GMP) Certificates
Issued by a recognized health authority in the country of origin, confirming compliance with international GMP standards. ISP Chile may request inspection reports or site certifications.

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 Chilean 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.

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 Chilean 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.

---

Compliance and Regulatory Requirements for Pharmaceutical Imports into Chile

Registration with Chilean Customs (Servicio Nacional de Aduanas)
Importers must be registered with Chilean Customs and have access to the Declaración Única Aduanera (DUA) system for customs procedures.

ISP Chile Product Registration and Approval
Most pharmaceuticals and medical devices must be registered with ISP Chile. This includes dossier submission, proof of GMP, stability data, labeling (in Spanish), and local regulatory representation.

Controlled Substances and Narcotics Permits
For products classified as psychotropics, narcotics, or precursors, special permits and quotas must be approved by ISP Chile and other relevant authorities, in compliance with Chilean controlled substances laws.

Work with a Licensed Customs Broker (Agente de Aduanas)
Due to the complexity of Chile’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 Brazil.
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, known locally under the NCM (Nomenclatura Comum do Mercosul), 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 Santos, FOB Toronto — defines cost and risk allocation. Common access ports in Brazil include Santos, Rio de Janeiro, and Paranaguá.

Shipping and Delivery Info
Port of Loading/Destination: E.g., New York → Santos → São Paulo.
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.

---

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 Brazilian importer or their appointed customs broker (Despachante Aduaneiro).

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.

---

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.

---

Certificate of Origin (for Pharmaceutical Products)

Exporter and Consignee
Full contact information for both parties.

Goods Description
List product names, NCM 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.

---

Key Considerations for Pharmaceutical Imports into Brazil

Technical Accuracy
Ensure all product information aligns with ANVISA 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 ANVISA.
Comply with Brazilian labeling standards (Portuguese required), expiration date policies, and traceability regulations.

Controlled Substances and Special Permits
Controlled drugs, narcotics, and precursors require prior authorization from ANVISA and compliance with Brazil’s National Drug Policy 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 Portuguese for submission to ANVISA and Receita Federal.

Work with Experts
Partner with a licensed Brazilian customs broker (Despachante Aduaneiro) and a regulatory consultant experienced with ANVISA to ensure compliance, avoid delays, and maintain cold chain integrity.