Key Documentation for Importing Pharmaceutical Products into Peru

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 Peru.

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 trade agreements such as the Andean Community (CAN) or the Pacific Alliance.

Import License / Authorization from DIGEMID
Pharmaceutical products and medical devices require prior approval from DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), under the Ministry of Health (Ministerio de Salud – MINSA). This applies to both commercial and public-sector imports.

Customs Declaration (Declaración Aduanera)
Formal submission to SUNAT (Superintendencia Nacional de Administración Tributaria), providing detailed information for fiscal, statistical, and regulatory processing of the import.

Product Registration Dossier
Documentation covering the product’s composition, therapeutic purpose, manufacturing process, quality control, clinical evidence, labeling, and safety profile. Required for all regulated products under DIGEMID’s jurisdiction.

Good Manufacturing Practice (GMP) Certificates
Issued by a recognized health authority in the country of origin. Peru requires valid GMP certification from internationally accepted regulatory bodies as part of product registration or import authorization.

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

Harmonized System (HS) Codes
Correct classification of products under Peru’s tariff system (based on WCO HS codes) is necessary to determine applicable import duties, tariffs, and VAT (IGV).

Pro-forma Invoice
Used during regulatory review or procurement procedures, particularly in public sector or humanitarian operations before final documentation is issued.

Cold Chain and Temperature Control Documentation
Required for temperature-sensitive products like vaccines, biologics, and certain injectables. Includes:

• Real-time temperature monitoring logs

• Thermal packaging validation

• Cold chain procedures in compliance with DIGEMID standards

Pharmacovigilance or Safety Data Sheets (SDS)
Mandatory for APIs, excipients, or hazardous chemicals. SDS must be in Spanish and comply with GHS standards, including handling instructions, storage conditions, and emergency measures.

Letter of Credit or Payment Terms Agreement
Defines agreed payment terms between exporter and importer. May be required by banks, customs authorities, or as part of compliance verification by SUNAT.

Import Duties and Taxes Payment
Evidence of payment for all import taxes, IGV (VAT), tariffs, and any special regulatory fees, as required for cargo release and final clearance by SUNAT.

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Compliance and Regulatory Requirements for Pharmaceutical Imports into Peru

Registration with SUNAT
Importers must be registered with SUNAT, comply with customs procedures, and work with authorized customs agents for pharmaceutical cargo clearance.

DIGEMID Product Registration and Authorization
All pharmaceuticals and medical devices must be approved by DIGEMID. The process includes dossier submission, GMP verification, labeling compliance (in Spanish), stability and shelf-life data, and appointment of a local sanitary representative or license holder.

Controlled Substances and Special Permits
Imports involving narcotics, psychotropics, or chemical precursors require special import permits issued jointly by DIGEMID and DEVIDA (Commission for the Development and Life Without Drugs), in compliance with Peruvian law and international drug conventions.

Work with a Licensed Customs Broker (Agente de Aduanas)
Due to the regulatory complexity of Peru’s pharmaceutical import environment, it is strongly recommended to partner with an experienced licensed customs broker and a regulatory consultant specializing in health products to ensure full compliance and cold chain integrity.

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 Peru.
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 Peru’s tariff schedule (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, PEN, etc.).

Terms of Sale (Incoterms)
E.g., CIF Callao, FOB Miami — defines cost and risk allocation. Common Peruvian ports and points of entry include Callao (sea port) and Jorge Chávez International Airport.

Shipping and Delivery Info
Port of Loading/Destination: E.g., Miami → Callao → Lima.
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 Peruvian 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 Peru

Technical Accuracy
Ensure all product information aligns with DIGEMID (Dirección General de Medicamentos, Insumos y Drogas) registrations, certificates of analysis, and packaging. Discrepancies may result in customs delays or rejection.

Regulatory Compliance
All pharmaceuticals must be registered and approved by DIGEMID, under the Ministry of Health (Ministerio de Salud – MINSA).
Comply with Peruvian labeling standards (Spanish required), expiration date rules, and applicable traceability protocols.

Controlled Substances and Special Permits
Controlled drugs, narcotics, and chemical precursors require prior authorization from DIGEMID and may also involve DEVIDA (Comisión Nacional para el Desarrollo y Vida sin Drogas), in compliance with Peruvian law and international treaties.

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 technical manuals — must be in Spanish for submission to DIGEMID and SUNAT (Superintendencia Nacional de Aduanas y de Administración Tributaria).

Work with Experts
Partner with a licensed Peruvian customs broker (Agente de Aduanas) and a regulatory consultant experienced with DIGEMID and SUNAT customs systems to ensure full compliance, avoid delays, and maintain product quality throughout the supply chain.