Customs Bonded Warehouses – Streamlining Clinical Trials

Clinical trials play a crucial role in the advancement of medical research and the development of new treatments. These trials involve the storage, distribution, and transportation of pharmaceutical products. It is therefore imperative to ensure strict adherence to regulatory compliance, safety, and security. To address these requirements, customs bonded warehouses have emerged as valuable assets in the field of clinical trials.

What is a Customs Bonded Warehouse?

A customs bonded warehouse is a specialised storage facility that operates under the supervision and control of customs authorities. A bonded warehouse falls under the rules and regulations of each country’s customs agent. As such, they are authorised by the government to store goods, including pharmaceuticals, in a secure environment with specific customs rights. These goods can be stored and handled without immediate payment of customs duties or taxes.

Key Differences Between Bonded and Non-bonded Warehouses

The main difference between a bonded and non-bonded warehouse lies in the customs-related privileges and obligations associated with each. While a non-bonded warehouse functions as a typical storage facility, a bonded warehouse offers additional benefits and responsibilities. These include:

• Customs Privileges: Bonded warehouses enjoy certain advantages granted by customs authorities, such as the deferment of customs duties and taxes until the goods are released from the warehouse. In addition, customs documentation is handled as part of the service provided by the warehouse operator.
  
  
• Cost Savings: The deferment of customs duties and taxes until such times as goods are ready for shipping means that sponsors are able to manage their budgets more effectively, particularly in instances when trials have a lengthy duration. In some instances, savings of up to 50% are possible compared to some established direct-to-site-models.

Oximio’s Bonded and Non-bonded Warehouse Solutions for Clinical Trials

With customs bonded warehouses in Kenya, Georgia and Serbia, Oximio can support clinical trials across the globe. In addition to the customs privileges and cost-savings offered by our bonded warehouse solutions, clients can benefit from our additional warehousing and depot facilities across Africa, Europe and the Middle East. Our bonded and non-bonded warehouses provide:

• Regulatory Compliance: Oximio’s customs bonded and non-bonded warehouses adhere to strict rules and regulations set by customs authorities. They undergo regular inspections, have enhanced security measures, and employ trained teams to handle controlled substances and sensitive pharmaceutical products. These measures ensure compliance with applicable regulations, such as Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), thereby promoting product integrity and patient safety.
  
  
• Traceability and Record-Keeping: We maintain meticulous records and provide transparent documentation throughout the storage and distribution process. This ensures full traceability, allowing researchers and regulatory bodies to track and verify the movement of pharmaceuticals at each stage of a clinical trial. Comprehensive record-keeping also facilitates efficient inventory management, simplifies audits, and minimizes the risk of regulatory non-compliance.
  
  
• Enhanced Security and Compliance: Our facilities offer heightened security measures, including access control, video surveillance and alarm systems. These measures protect valuable investigational products and minimize the risk of theft, tampering, or unauthorised access. Moreover, strict compliance with regulations ensures that clinical trial supplies meet the required quality standards, safeguarding the integrity of research outcomes.
  
  
• Efficient Logistics and Inventory Management: Our warehouses provide dedicated facilities for the handling, storage, and distribution of clinical products. Their specialised infrastructure, along with robust logistics capabilities, enables efficient management of inbound and outbound shipments, reducing the risk of product loss or delays.
  
  
• Temperature Control: Our custom bonded and non-bonded warehouses can offer specialist temperature control solutions such as ultra-low temperature freezers or cryogenic storage facilities assuring the quality of samples and medicines at all times.

Kenya – Customs Bonded Warehouse

Oximio’s Kenyan customs bonded warehouse is perfectly located for local and cross-border shipments. It is conveniently located outside of Nairobi city centre and just 25minutes from the Jomo Kenyatta International Airport, Kenya. It acts as a central warehouse for local clinical trial studies and supports sponsors in East, Central and West Africa through its Customs Bonded Warehouse license. Clinical Trial Material can be stored “In Bond” for up to 18 months whilst ‘in transit’ to different countries and goods too, may be released “From Bond” to be used within the Kenya Borders.

De-risking the supply chain using Customs Bonded Warehouse

Kenya’s customs bonded warehouse incorporates a resident On-site Customs Official. This means that when Clinical Trials Material (CTM) arrives at Kenya Airport, a Customs ‘Document Check’ is performed for correctness and the CTM is then transported in a Customs Bonded TMV to OXIMIO’s Kenyan warehouse. Here it is receipted and inspected in the presence of the On-Site Customs Official within the correct Temperature Storage Area, thus avoiding pilferage, damages, and temperature excursions.   

Similarly, all Exports follow the same process whereby the On-Site Customs Official is present during the final packing and performs Customs Releases of the consignment. This is then , once again, in a Customs Bonded TMV to Kenya Airport for Customs ‘Document Check’ and onward freight forwarding which further de-risks pilferage, damages, and temperature excursions.

Relabelling and repacking solutions

Oximio can also provide relabelling services for CTM whilst in the Bonded area for export to other countries. For example,  “unlabelled” medicines can be received from a client for a multi-country study which may require translation of the product label. This can be carried out by Oximio along with JIT, Use Date, Re-packing and Patient Kit assembly with the primary pack remaining intact. All CTM will remain “In Bond” until shipping is requested, and the products released for local distribution or export.