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.

Certification

Wholesale Dealer’s License
Practice licence for pharmacist
ISO9001 Certified

Storage

Overall capacity: 472 m²
Non-Controlled ambient
Controlled ambient: +15⁰C to +25⁰C
Refrigerated: +2⁰C to +8⁰C
Frozen: -25⁰C to -15⁰C
Ultra-low: -80⁰C to -60⁰C
Cryogenic: on request

Product Types

Controlled drugs
Dangerous goods
Biological goods
Blood product or derivative
Genetically modified organism
Antibiotic
Cytotoxic

Providing end-to-end solutions for clinical trials logistics, find out more about the comprehensive range of services offered by Oximio, Kenya.

Georgia – Customs Bonded Warehouse

Georgia’s bonded depot is located in the capital, Tbilisi, and was one of the first countries in Oximio’s geographical expansion story.

The bonded depot also offers a full relabelling function from receipt of unlabelled products to the preparation and printing of new labels for onward distribution. Services include repackaging, kit assembly and the division of bulk consignments to smaller packages for shipping to multiple countries. There is no limitation on the time that materials can be stored in the FIZ warehouse.

Certification

GDP Certificate
ISO 9001:2015 Certificate
Wholesale Distributor License

Storage

Overall storage capacity: 294 m²
Non-Controlled ambient
Controlled ambient: +15⁰C to +25⁰C
Controlled ambient: +2⁰C to +8⁰C

Product Types

Dangerous goods*
Biological goods
Blood product or derivative
Genetically modified organism
Antibiotic
Cytotoxic

*Dangerous goods subject to MSDS information.

Georgia’s custom bonded warehouse is supported with a local depot. This means that they can provide a complete portfolio of clinical trial logistics services from start to finish. Explore the logistic solutions from Oximio, Georgia.

Serbia Bonded Depot

Serbia’s bonded depot further enhances the clinical trials landscape in Southeast Europe, bringing with it increased efficiency, centralised supply chain governance and a 50% cost saving compared to other, established direct-to-site models. Located within the standard warehouse, it is a convenient 20 km from Belgrade airport. Following GMP best practice, the bond offers a comprehensive range of services including labelling and JIT labelling with the exception of expiry extension. This enables the client to have smaller quantities labelled avoiding additional costs. It is worth noting that once EU released goods have left the EU, they can be returned for further usage without paying customs fees. However, EU QP release is required if needed for use within the EU.

The depot team can also import medical devices for clinical trials in addition to drugs.

Certificates:

WHL License
ISO 9001:2015 Certificate

Storage:

Overall storage capacity: 385 m2
Non-Controlled ambient: 82.1 m² (bonded warehouse represents 14.3 m2)
Ambient: 15⁰C – 25⁰C: 93.8 m² (bonded warehouse represents 14.3 m2)
Cold Chain: 2⁰C – 8⁰C: 51 m² (bonded warehouse represents 9.5 m²)
Frozen: -40°C to -20°C: On request
Ultra-low -80°C to -25°C: On request
LN2 (Cryogenic): On request
Office and other non-controlled: 158.1 m²

Product Types:

Biological Goods
Blood Product or Derivative
Antibiotic
Cytotoxi
Controlled Drugs on Request

Oximio’s bonded warehouse in Serbia, coupled with its local depot, supports the full spectrum of clinical trial logistic services. Explore the range of services from Oximio, Serbia.

Oximio’s Global Network

With bonded depots and warehouse facilities stretching across Europe, Middle East and Africa, and supported with a comprehensive partner network depot, we can support clinical trials globally. To find out how we can support you with your clinical trials, simply contact us today.