Risk and Common Mistakes in Import and Export Documentation for Clinical Trials

April 11, 2018 James Linnington

International trade was never a simple business as it involves different countries, regulations, licenses and documentation requirements. Good control of documents is something which can always make the whole process smoother and reduce risks.  For clinical trials, we import and export medication and different materials around the world which are accompanied by various documentation for smooth custom clearance. Two such documents are the Customs Invoice (CI) and Air Way Bill (AWB).  When import or export license applications are submitted at various health agencies, these documents are often used as reference.

If the documents are incorrect, then the license application and the final IL/EL (import/export license) will also be incorrect.

Risks of incorrect documentation include:

  • Losing importer/exporter authorization
  • Monetary fine
  • Shipments getting stuck at customs

Ultimately, in clinical research, these risks can jeopardize the delivery of clinical supplies to the trial subjects.

The Customs Invoice

An accurate customs invoice should have following information to ensure a smooth international shipping process:

  • Shipper: Identifies shipping country, which may be required on the IL (import license) application.
  • Importer of Records: Identifies who is legally responsible for the goods in the importing country.
  • Broker: Customs Agency that will provide support to the importer during customs clearance.
  • Consignee: Receiver of the goods.
  • Invoice title: Customs or Commercial may be preferred depending on local regulations.
  • Incoterm: States shipping terms that will determine responsibilities in payment of duties and taxes.
  • Material description: Identifies items to be imported.
  • Quantity: Informs customs quantity of items in the package, and helps verify availability if IL is required
  • Harmonized System Code: Classifies the item for customs clearance.
  • Values: For customs clearance purposes.
  • Weight: For shipping and customs clearance purposes.
  • Informs the purpose of the import, and specific components/ingredients.

Where we can find common mistakes in the customs invoice?

  • Lot number
  • Expiration date
  • Value of the merchandise
  • Drug description
  • Country of origin
  • Incoterm
  • Concentration and/or presentation of the medication
  • Quantity of units
  • Exporter/Consignee/Importer of Record

The Air Waybill

While reviewing an Air Way Bill we should check the following details

  • Shipper: Full and detailed information
  • Consignee: Who should receive the shipment?
  • Airport of departure and destination
  • Description of product: Depending on type of goods, the regulations could require additional permits.
  • Information of temperature: Handling instructions.
  • Net and gross weight.
  • Freight value is mandatory fields and in some countries must be provided in advance to obtain licenses.  

 Where we can find common mistakes in the Air Way Bill?

  • Consignee information
  • Storage conditions
  • Temperature
  • Freight value
  • Weight
  • Quantity of pieces
  • Change of AWB: Some import licenses include the AWB number. It’s possible that then AWB number changes, so import license will be not valid.

Foreign trade operations  require  a  large amount of information and documents.

Before a study is submitted at the health agencies, it’s necessary to do a quality check of the materials list to be imported/exported, against the draft documents, such as the Customs Invoice and Air Way Bill.

Once the operation starts, it’s very important that new quality checks are performed for specific shipments. There will be a second review that all information matches between the final documents and to achieve the customs clearance processes.

With these two controls we will achieve successful delivery of the clinical material to the clinical trial sites and patients in a timely manner.

Prakash Singh and
Juan Bamberger

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