Pharmaceutical Logistics to the Highest Quality Standards
Import of medicines, medical devices and pharmaceutical raw materials under strict GDP standards, certified cold chain and ISP management.
Pharmaceutical Logistics: Import of Medicines and Healthcare Supplies
The pharmaceutical and healthcare industry imposes the strictest regulatory standards in international trade. In Chile, the Public Health Institute (ISP) regulates the entry of medicines, medical devices and biological products through a registration and authorisation system that requires detailed technical documentation and compliance with Good Distribution Practices (GDP).
Importing a medicine or medical device into Chile is not like importing any other goods. It requires the product to be previously registered with the ISP (or to have a special import authorisation), the importer to be authorised by the ISP as a pharmaceutical warehouse or pharmacy, and the entire logistics chain to comply with temperature, humidity and safety requirements defined in the GDP.
The consequences of a logistics error in the pharmaceutical industry are enormous: a medicine exposed to incorrect temperatures during transport may lose its effectiveness or become dangerous to the patient. Damaged medical equipment must be destroyed. And an import without the correct documentation can result in indefinite cargo retention by the SNA or ISP, affecting supply to hospitals, clinics and pharmacies.
FirstCargo has developed specific protocols for pharmaceutical logistics that guarantee compliance with all ISP regulations and international regulatory agencies (FDA, EMA), with audited temperature documentation for each shipment.
How FirstCargo serves your sector
Pharmaceutical GDP Cold Chain
Air and sea transport of medicines under strict temperature control (2°C–8°C for biologicals, 15°C–25°C for controlled ambient temperature) with calibrated dataloggers and auditable temperature reports.
ISP Registration Management
Advisory and coordination for health registration management with the ISP, special import authorisations for unregistered medicines and compliance with ISP documentary requirements.
Medical Device Import
Management of the import process for medical devices (diagnostic equipment, implants, surgical instruments) with the corresponding ISP notification or registration and required risk classification.
Raw Materials for Pharmaceutical Industry
Import of APIs (active pharmaceutical ingredients), excipients and raw materials for local pharmaceutical laboratories, with documentation of manufacturer GMP certificates and quality analyses.
Why choose FirstCargo for your sector?
Full GDP Compliance
Processes aligned with WHO Good Distribution Practices (GDP) and ISP Chile guidelines for medicine distribution.
Audited Temperature Documentation
Temperature reports with certified dataloggers for each pharmaceutical shipment. Documentation available for internal and ISP audits.
ISP Chile Experience
In-depth knowledge of ISP Chile processes and requirements for the import of medicines and medical devices.
Discretion and Security
Reinforced security protocols for high-value medicines, psychotropics and narcotics, with coordination with CONACE authorities and the SNA.
Services for this sector
Frequently Asked Questions
For medicines without health registration in Chile, there is the ISP special import authorisation, used for medicines intended for personal use, clinical trials or emergency supply. The process requires importer authorisation and technical product documentation. We advise on the specific requirements of each case.
Medical devices in Chile require ISP notification or registration according to their risk class (I, II, III or IV). The basic documents are: ISP registration or import resolution, manufacturer certificate (ISO 13485), declaration of conformity and commercial invoice. Our team guides you on the specific requirements for each type of device.
Yes, we coordinate the transport of biologicals (vaccines, insulin, monoclonal antibodies) in isothermal containers and specialised packaging (dry ice, gel packs, cryogenic containers) that maintain temperatures from 2°C to 8°C throughout air transit, which is the most common mode used for biologicals.
Need reliable pharmaceutical logistics in Chile?
Contact us to design a pharmaceutical import solution that meets all ISP standards and international GDP requirements.
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