A man stands beside a van with the CRYOPDP logo, ready to transport biological samples in a temperature-controlled environment.

Navigating the Complexities of Shipping Human Biological Samples: A Comprehensive Guide

Shipping human biological samples requires meticulous handling and strict compliance with regulations to ensure safety and legal compliance. Additionally, efficient door-to-door logistics are essential to maintaining sample stability while prioritising patients’ health.  

Unlocking the Unknown of Shipping Human Biological Samples: A Definitive Roadmap

  • Classification and Declaration

    Human biological samples, like blood, human cells, urine or saliva, are usually classified as Category B Biological Substances and/or UN3373 according to international rules from bodies like the International Air Transport Association (IATA) and the International Civil Aviation Organization (ICAO). When shipping, the sender must accurately declare what’s inside the package on the shipping paperwork, specifying that it contains Category B Biological Substances/UN3373 and providing details about the samples. The shipper must confirm the end purpose of the sample (i.e. it is used for testing to be destroyed after or used for manufacturing).

  • Packaging

    Samples must be packed in purpose-built packaging solutions, like tubes or vials, that won’t leak or break. These containers should use secondary solid packaging, including absorbent material, to remove leaks. The samples can be transported in various temperatures depending on the sample type and the end purpose. (see whole CRYOPDP temperatures)

  • Labelling

    Correctly labelling the package is vital for identification and safe handling. Labels should state the proper shipping name, Category B Biological Substance, include the UN3373 marking for international shipments, and have the sender and recipient’s details. The shipper must have a biohazard symbol and special handling instructions or warnings. The correct statement needs to be shown on the airline/carrier shipping paperwork so this is handled accordingly and stored at the right temperature while in transit.

  • Documentation

    To cross a country’s customs borders with a shipment, official declarations to customs authorities are required, making a customs Invoice essential for clearance. The responsibility for compliance with the regulations of the countries involved, as well as providing the necessary customs documents, is shared by both the exporter and importer. Recent trends have revealed varying levels of accuracy and completeness in customs invoices, with many lacking critical information needed for import customs clearance. It’s important to remember that shipping documents are reviewed by the CRYOPDP International Logistics Team and the customs authorities responsible for clearance. Therefore, ensuring that the customs invoice is in English and contains all required details is crucial. A thorough Customs Invoice meets requirements and facilitates a smoother and faster customs clearance process, reducing delays and ensuring a more efficient procedure.

Here are the UK import customs invoice instructions (BPR – Best Practice Recommendations; MI – Mandatory Information that must be included on the Commercial Invoice):

Invoice Details

  • Use company letterhead (exporter or importer). (BRP)
  • Specify the invoice type (Commercial, Customs, or Proforma). (MI)
  • Include the invoice date and a unique reference number. (MI)

Exporter of Record/Consignor

  • Provide the company’s name, address, and contact details. (BRP)
  • Include the Customs Identification number (issued by the country of export). (MI)
  • Add the Consignor’s information if different from the Exporter of Record. (MI)

UK Import of Record/ UK Consignee

  • Include the company’s name, address, and contact details. (MI)
  • Specify the UK Customs registration number (GB EORI) and Value Added Tax Identification number (GB VAT). (MI)
  • Add the Consignee’s information if different from the Importer of Record. (MI)

Product(s) Shipped (for each item)

  • State the quantity of items. (MI)
  • Provide a clear and complete description of the item in plain English. (MI)
  • Any Medium or Preservative of animal origin used as a carrier or stabiliser. (MI)
  • Include the commodity code or ten digits of the UK Tariff code. (MI)
  • Specify the country of origin for each item. (MI)
  • Mention the product value per unit (excluding taxes). (MI)
  • Add a product code and batch number (if applicable). (BRP)
  • Include the CAS number for chemicals or the UN number for the carriage of dangerous goods (if applicable). (BRP)

Intended Use Statement

  • Define the intended use of the product at the destination (i.e. research, diagnosis, clinical study, manufacture) (MI)
  • Clearly state whether the product is of animal or human origin. (MI)
  • Clearly state whether the product is destined for human use or not for human use. (MI)

Compliance Statements

  • Some products, including but not limited to origin, plants, animal products, pathogen carriers, pharmaceuticals, drug precursors, and controlled drugs, are tightly regulated when imported. The customs invoice must show the relevant import permit or licence conditions of the product shipped. (MI)

Total Value

  • State the total invoice price (excluding taxes) (MI)
  • Specify the currency (EURO, USD or GDP) (MI)
  • Include freight costs if they are not printed on any accompanying documents. (BRP)

Weights

  • Provide the net weight in kilograms. (MI)
  • Specify the gross weight in kilograms. (MI)

Incoterms

  • Use the delivery terms proposed by Incoterms 2020 with the applicable English abbreviation and the place of delivery. (i.e. EXW, DAP, DDP) (MI)

Number of Parcels & Pallets

  • Clearly define the type of packaging used. (BRP)

Finalise the Invoice

  • Include a signature, date, and the name of the person who created the invoice. (BRP)

You’ll need various documents depending on where and how you’re sending the samples. These could include an air waybill, a shipper’s declaration for dangerous goods, customs forms, a packing list detailing what’s inside, and any necessary permits or licences. 

It’s a comprehensive list of documents for the International Shipping of Biological Samples:

  • Air Waybill (AWB): A document the carrier (airline) issued acknowledging receipt of goods for transport, detailing the shipment’s destination and contents.
  • Shipper’s Declaration for Dangerous Goods (if applicable): This declaration is required for hazardous materials shipments. It must declare the dangerous goods’ nature, quantity, and handling instructions.
  • Customs Forms: Documentation required by customs authorities to facilitate the clearance of goods across international borders. It may include customs declarations, import/export permits, and other relevant forms.
  • Packing List: An itemised list detailing the shipment’s contents, including descriptions, quantities, and values of each item.
  • Permits or Licences: Any necessary permits or licences required for the import/export of biological samples, such as health permits, import licences, or CITES (Convention on International Trade in Endangered Species) permits for samples derived from protected species.
  • Certificate of Origin (if applicable): A document certifying the country of origin of the goods, which may be required for customs clearance purposes.
  • Documentation Specific to Biological Samples: This may include a Material Safety Data Sheet (MSDS) detailing the hazards and handling precautions associated with the biological samples and any other relevant documentation specific to the nature of the samples being shipped.
  • Invoice: see above
  • Export Control Documents (if applicable): Documents required to export certain controlled goods, such as dual-use items, subject to export controls.
  • Certificate of Analysis (if applicable): A document certifying the quality and composition of the biological samples, which may be required for regulatory compliance or quality assurance purposes.
  • Other Regulatory Documentation: Depending on the destination country and the nature of the samples, additional regulatory documentation may be required to ensure compliance with local regulations and standards.
  • Carrier-Specific Documentation: Any additional documentation required by the chosen carrier (e.g., shipping instructions, booking confirmation, or transport contract).

Transportation

The shipper and the logistics provider must choose a reputable carrier with experience handling biological samples. Ensure the airline follows the regulations and has the proper facilities for safe transportation. Use faster shipping methods to keep transit times short and maintain sample quality.

It is crucial to remember that civil aviation security regulations must be adhered to when shipping via air. Cargos planning to travel by air must undergo security screening by a Civil Aviation Authority (CAA) or equivalent authorities in other countries. Approved screening methods include X-rays, Explosive Detection Devices (ETD), Free Running Explosive Detection Dogs (FREDDS), and hand searches. X-ray screening may destabilise or damage human cells or genes shipped for Cell & Gene Therapy. Hence, shippers need to plan to mitigate such risks. Contact the CRYOPDP team in the UK for comprehensive guidance on safe shipping practices. Our team assesses commodity type and packaging performs risk assessments and advises best practices. 

Regulations Compliance

The shipper must be familiar with the rules for shipping biological samples in your country and any international regulations that apply. Ensure all packaging, labelling, and documentation meet these regulations to avoid delays or rejection during transit. 

Training

Anyone packing and shipping biological samples should receive proper training to handle them safely and comply with regulations. When shipping human biological samples, always consult relevant regulatory authorities and carriers to comply with all applicable regulations. If in doubt, seek advice from professionals experienced in shipping such materials for tailored guidance.

CRYOPDP: Leaders in Temperature-Controlled Logistics

CRYOPDP is a leader in temperature-controlled logistics, specializing in safely transporting human biological samples. We handle various biological materials, ensuring that blood, cells, and other sensitive items are delivered safely and efficiently. Our capabilities include navigating customs regulations, managing documentation, and ensuring compliance for smooth international shipping.

The CRYOPDP UK team plays a crucial role in our success. With extensive experience and knowledge of international shipping, they guide you through the entire process, from packaging and labeling to customs paperwork. The UK team also understands the importance of temperature-controlled logistics, offering reliable door-to-door service while keeping your samples stable throughout transit.

Choose CRYOPDP for a logistics partner that prioritizes safety, compliance, and customer satisfaction.

Author: Alex Frumusache, UK Operations Director @CRYOPDP

References
1. HMRC Help
2. https://www.gov.uk/guidance/apply-for-cites-permits-and-certificates-to-trade-endangered-species
3. http://apha.defra.gov.uk/official-vets/Guidance/bip/iin/abp-not-hum-cons.htm
4. https://www.gov.uk/guidance/importing-live-animals-or-animal-products-from-non-eu-countries-general-licences-and-authorisations
5. https://www.gov.uk/guidance/contact-defra#animal-health-and-welfare
6. https://www.gov.uk/guidance/bringing-specified-animal-pathogens-into-gb#download-and-print-a-general-licence
7. https://www.gov.uk/government/collections/importing-and-exporting-plants-and-plant-products
8. https://www.gov.uk/guidance/controlled-drugs-import-and-export-licences
9. https://www.gov.uk/government/publications/precursor-chemical-import-and-export-authorisation-wallchart