Key Documentation for Importing Pharmaceutical Products into Brazil

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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.

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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 Brazil.

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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.

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Certificate of Origin

Verifies the country of manufacture for the goods. Often required to apply for reduced duties under bilateral or MERCOSUR trade agreements.

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Import License / ANVISA Authorization

All pharmaceutical products and medical devices generally require prior import approval from ANVISA (Agência Nacional de Vigilância Sanitária) through SISCOMEX and compliance with Brazilian health regulations before customs release.

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Customs Declaration

Formal submission to Receita Federal do Brasil via the SISCOMEX system, providing detailed information for fiscal and regulatory validation of the import.

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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 ANVISA.

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Good Manufacturing Practice (GMP) Certificates

Issued by a recognized health authority in the country of origin, confirming compliance with international GMP standards. ANVISA may request inspection reports or site certifications.

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Insurance Certificate

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

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Harmonized System (HS) Codes

Correct classification of products under the Brazilian Mercosur Common Nomenclature (NCM), based on the HS Code, is necessary to determine import duties, IPI (Excise Tax), and ICMS (State Tax).

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Pro-forma Invoice

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

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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.

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Pharmacovigilance or Safety Data Sheets (SDS)

Mandatory for APIs, excipients, and hazardous chemical substances. SDS must be in Portuguese, detailing proper handling, storage, and emergency response protocols.

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Letter of Credit or Payment Terms Agreement

Defines agreed international payment terms between buyer and seller. Often required by Brazilian customs and financial institutions for final cargo release.

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Import Duties and Taxes Payment

Receipts or confirmations of payment for applicable Import Duty, ICMS, PIS/COFINS, and AFRMM (additional freight tax for maritime transport) must be submitted to clear the goods.

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Compliance and Regulatory Requirements for Pharmaceutical Imports into Brazil

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Registration with Receita Federal & RADAR/SISCOMEX Access

Importers must be registered with Receita Federal do Brasil and obtain access to RADAR (Brazil’s electronic foreign trade system) and SISCOMEX for customs procedures.

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ANVISA Product Registration and Approval

Most pharmaceuticals and medical devices must be registered with ANVISA. This includes dossier submission, proof of GMP, stability data, labeling (in Portuguese), and local regulatory representation.

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Controlled Substances and Narcotics Permits

For products classified as psychotropics, narcotics, or precursors, special permits and quotas must be approved by ANVISA and Polícia Federal, in compliance with Brazil’s controlled substance laws.

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Work with a Licensed Customs Broker (Despachante Aduaneiro)

Due to the complexity of Brazil’s tax structure and regulatory requirements, it is highly advisable to work with a licensed customs broker with expertise 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.

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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 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.

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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, 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.

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Key Considerations for Pharmaceutical Imports into Brazil

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Technical Accuracy

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

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Regulatory Compliance

• All pharmaceuticals must be registered and approved by ANVISA.

• Comply with Brazilian labeling standards (Portuguese required), expiration date policies, and traceability regulations.

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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.

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Cold Chain and Handling

Temperature-sensitive goods must include:

• Validated thermal packaging

• Continuous temperature monitoring

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

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Language Requirements

All key documents — labels, certificates of analysis, SDS, and manuals — must be in Portuguese for submission to ANVISA and Receita Federal.

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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.