Key Documentation for Importing Pharmaceutical Products into Argentina

Commercial Invoice
A detailed invoice outlining the transaction, including buyer/seller information, full description of the pharmaceutical products (e.g., medicines, APIs, medical devices), quantities, 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.

Packing List
An itemized list of all cargo, including packaging formats (e.g., blister packs, vials, pallets), lot numbers, batch codes, dimensions, gross/net weights, and packaging details — crucial for customs and regulatory clearance.

Certificate of Origin
Confirms the country of manufacture for the products. Often necessary to benefit from preferential trade agreements or reduced import duties.

Import License / ANMAT Authorization
Pharmaceuticals and medical devices generally require import authorization or registration with ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) before entry into Argentina.

Customs Declaration
Formal submission to the Dirección General de Aduanas (DGA), providing comprehensive details of the imported pharmaceutical goods.

Product Registration Dossier
Documentation of product formulation, manufacturing process, safety, efficacy, and quality — mandatory for all medicinal products and regulated by ANMAT.

Good Manufacturing Practice (GMP) Certificates
Issued by the relevant health authority in the country of origin, certifying that the pharmaceutical products were produced under GMP standards.

Insurance Certificate
Proof of cargo insurance for the shipment, especially important for high-value and temperature-sensitive products.

Harmonized System (HS) Codes
Accurate classification of pharmaceutical products under the HS Tariff Schedule, determining applicable import duties, VAT, and statistical tracking.

Pro-forma Invoice
Used for preliminary customs or regulatory approvals and initial commercial negotiations, especially in multi-stage procurement or trial shipments.

Cold Chain and Temperature Control Documentation
Essential for biologics, vaccines, and other temperature-sensitive products — includes temperature logs, real-time monitoring reports, and packaging specifications (e.g., thermal containers).

Pharmacovigilance or Safety Data Sheets (SDS)
Mandatory for some active ingredients or chemical components, ensuring safe handling during transport and customs inspections.

Letter of Credit or Payment Terms Agreement
Defines international payment terms between buyer and seller, often required by customs or banks to authorize cargo release.

Import Duties and Taxes Payment
Receipts or confirmation of import duty, VAT (IVA), statistical fee payments, and any applicable pharmaceutical levies.

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Compliance and Regulatory Requirements for Pharmaceutical Imports

Registration with Argentine Customs (AFIP/DGA)
Importers must be registered with Argentine Customs and have a valid CUIT (Código Único de Identificación Tributaria) number.

ANMAT Product Registration and Compliance
Pharmaceuticals must be registered and approved by ANMAT. This includes fulfilling requirements for safety, efficacy, labeling, language conformity, and advertising restrictions.

Controlled Substances and Narcotics Permits
Special permits are mandatory for importing controlled substances, psychotropics, or narcotics, in strict compliance with Argentine regulations.

Engage with a Licensed Customs Broker
Given the high level of regulatory oversight in Argentina’s pharmaceutical sector, working with a local customs broker experienced in ANMAT procedures and cold chain logistics is essential for timely and compliant import operations.

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 Argentina.

• 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 (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, etc.).

Terms of Sale (Incoterms)

• E.g., CIF Buenos Aires, FOB Toronto — defines cost and risk allocation.

Shipping and Delivery Info

• Port of Loading/Destination: E.g., New York → Buenos Aires.

• Estimated Shipping Date: Projected departure date.

Payment Terms

• Method: L/C, TT, Net-30, as per the sales 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 Argentine importer or their designated customs broker.

Carrier Information

• Name: Shipping line or logistics provider.

• Transport Mode: Include air/sea carrier and flight or vessel details.

Description of Goods

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

Gross Weight and Dimensions

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

Freight Charges

• Charge Terms: Indicate prepaid or collect and the responsible party.

BOL Number

Unique reference number for shipment 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 maintenance responsibilities if required.

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Packing List (for Pharmaceutical Products)

Exporter and Consignee Information

Must match commercial invoice and BOL exactly.

Shipment Details

Include invoice number, BOL number, and shipment date.

Itemized Contents

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

Quantities and Packaging Type

Include number of packs, blister cards, cartons, pallets, and container type (e.g., thermal shippers, dry ice units).

Package Identification

Labels such as “BOX 1/20 – VACCINE – KEEP REFRIGERATED”.

Total Weight and Volume

Indicate gross and net weight and total shipment volume.

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Certificate of Origin (for Pharmaceutical Products)

Exporter and Consignee

Full contact details of both parties.

Goods Description

Product names, HS codes, dosage forms, and intended use (human/veterinary).

Origin Criterion

Country of manufacture (e.g., “Manufactured in Germany”).

Certification

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

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Key Considerations for Pharmaceutical Imports into Argentina

Technical Accuracy

Ensure product descriptions match ANMAT registrations, batch certificates, and packaging labels to avoid customs delays.

Regulatory Compliance

• All pharmaceuticals must comply with ANMAT regulations regarding registration, labeling, shelf life, and import licensing.

• Controlled substances require special permits.

Cold Chain and Handling

Temperature-sensitive products must include:

• Validated thermal packaging

• Real-time temperature monitoring

• Cold chain logs and SOPs

Language Requirements

All labeling, certificates of analysis, and manuals may need to be provided in Spanish, particularly for customs and ANMAT review.

Work with Experts

Partner with a licensed customs broker and regulatory consultant experienced in Argentina’s pharmaceutical regulations to ensure smooth clearance and full compliance.