Key Documentation for Importing Pharmaceutical Products into Bolivia

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 / DIGEMID or SENASAG Authorization
Pharmaceutical products and medical devices generally require prior import authorization or product registration with DIGEMID Bolivia (Dirección General de Medicamentos y Tecnología en Salud) or SENASAG (for certain health-related products) before customs clearance.

Customs Declaration
Formal submission to the Aduana Nacional de Bolivia (ANB), providing full details of the imported pharmaceutical goods for regulatory and statistical tracking.

Product Registration Dossier
Documentation of the product’s composition, manufacturing process, safety profile, and efficacy — required for all pharmaceuticals and subject to DIGEMID approval.

Good Manufacturing Practice (GMP) Certificates
Issued by the appropriate authority in the country of origin, verifying the pharmaceutical products are produced according to internationally accepted GMP standards.

Insurance Certificate
Proof of cargo insurance, especially important for high-value, temperature-sensitive, or high-risk shipments.

Harmonized System (HS) Codes
Correct HS classification of all imported pharmaceutical products, which determines applicable import tariffs, VAT, and controls.

Pro-forma Invoice
Used for preliminary regulatory review, quotation purposes, and customs pre-approvals during procurement processes or early negotiations.

Cold Chain and Temperature Control Documentation
Required for biologics, vaccines, and other temperature-sensitive items. Must include temperature data logs, packaging specifications, and compliance with international cold chain standards.

Pharmacovigilance or Safety Data Sheets (SDS)
Mandatory for certain APIs or chemicals. Provides essential safety and handling information for customs and public health authorities.

Letter of Credit or Payment Terms Agreement
Defines international payment terms between buyer and seller — often required by Bolivian banks or customs authorities for final release of goods.

Import Duties and Taxes Payment
Confirmation or receipts for customs duties, IVA (Impuesto al Valor Agregado), and other applicable national or departmental taxes.

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Compliance and Regulatory Requirements for Pharmaceutical Imports into Bolivia

Registration with Bolivian Customs (ANB)
Importers must be officially registered with the Aduana Nacional de Bolivia and possess a valid NIT (Número de Identificación Tributaria).

DIGEMID Product Registration and Approval
Pharmaceuticals and medical devices must be authorized by DIGEMID before importation. This includes requirements for product testing, labeling in Spanish, documentation, and country-of-origin certification.

Controlled Substances and Narcotics Permits
Special import permits are required for substances regulated under Bolivia’s controlled drugs framework, including psychotropics and narcotics. Compliance with international conventions and Bolivian health laws is mandatory.

Work with a Licensed Customs Broker
Due to Bolivia’s complex regulatory and customs environment, especially for pharmaceutical products, it is strongly recommended to work with a licensed customs broker or logistics agent experienced in healthcare imports and cold chain coordination.

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 Bolivia.

• 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 total invoice value.

Currency

• Type: Clearly stated (USD, EUR, etc.).

Terms of Sale (Incoterms)

• E.g., CIF Arica, FOB Toronto — defines cost and risk allocation. Arica and Ilo are commonly used access points to Bolivia.

Shipping and Delivery Info

• Port of Loading/Destination: E.g., New York → Arica → La Paz.

• 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 Bolivian importer or their appointed customs broker.

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,” “COVID-19 test kits,” consistent with the commercial invoice.

Gross Weight and Dimensions

Provide accurate total weight and volume per pallet or package, especially important for temperature-sensitive cargo.

Freight Charges

• Charge Terms: State whether charges are prepaid or collect, and who is responsible.

BOL Number

Unique reference number for shipment tracking.

Date of Shipment

Date the goods were physically dispatched.

Terms and Conditions

Include liability clauses, applicable conventions (e.g., Warsaw or Montreal for air, Hague-Visby for sea), and cold chain maintenance obligations.

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Packing List (for Pharmaceutical Products)

Exporter and Consignee Information

Must match the commercial invoice and BOL exactly.

Shipment Details

Include invoice number, BOL number, and shipment date.

Itemized Contents

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

Quantities and Packaging Type

State the number of packs, cartons, pallets, and container types (e.g., thermal shippers, dry ice packaging).

Package Identification

Label each item clearly (e.g., “BOX 1/20 – VACCINE – KEEP REFRIGERATED”).

Total Weight and Volume

Include gross and net weights and overall volume of the shipment.

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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 application (e.g., human or veterinary use).

Origin Criterion

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

Certification

Document signed and stamped by a Chamber of Commerce or recognized export certifying authority.

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Key Considerations for Pharmaceutical Imports into Bolivia

Technical Accuracy

Ensure all product details on documentation match DIGEMID Bolivia registrations and batch certificates to avoid customs and regulatory delays.

Regulatory Compliance

• All pharmaceutical products must be registered with DIGEMID Bolivia or the relevant authority (e.g., SENASAG for veterinary/biological inputs).

• Labeling, shelf life, language requirements (Spanish), and packaging must comply with Bolivian health regulations.

Controlled Substances and Special Permits

Controlled drugs, narcotics, and psychotropic substances require special import permits and must comply with both Bolivian law and international conventions.

Cold Chain and Handling

Temperature-sensitive goods must include:

• Validated cold chain packaging

• Real-time temperature monitoring

• Cold chain documentation (logs, SOPs, alarms if applicable)

Language Requirements

Certificates of analysis, safety data sheets, and product labels must often be provided in Spanish, particularly when subject to DIGEMID or SENASAG inspections.

Work with Experts

Partner with a licensed Bolivian customs broker and a regulatory consultant experienced in pharmaceutical imports, especially for compliance with Aduana Nacional (ANB), DIGEMID, and cold chain logistics.