Exporting Biological Samples From Mexico

24 Mar, 2015 by  Leo Harcha

As a CRO or central lab conducting clinical trials in Latin America, you have probably experienced the regulatory complexities when exporting biological samples from Mexico. Exporting tissue and blood samples from Mexico is subject to specific export controls often requiring Export Permits.

There is however a way to simplify the process: you do not have to request an Export Permit, as long as you have an "Approved Protocol" from an organization in Mexico called COFEPRIS.  

Regulation 3.1.28 from the Mexican General Foreign Trade Association clarifies that Blood Samples pertaining to the “Approved Protocol” from the MOH Authority can be exported only by presenting an Export Document called a PEDIMENTO to Customs through a local Broker. 

In Mexico, the Pedimento is the most important customs form used during the importation or exportation of goods, and can only be completed by a local customs broker at the request of the importer or exporter.

 

Information Required For Creating a PEDIMENTO:

  • Protocol Number / Sponsor Name
  • Commercial invoice including type of samples you are exporting: Blood, Plasma, Serum, amount of milliliters per tube and amount of tubes and value for each item
  • If the protocol has samples from various cities, the consolidated amount of tubes and milliliters must be consolidated, and the broker must be advised
  • A Commercial Invoice to export is not the invoice from each site to the final laboratory, it is a new invoice created at the time of processing the export, (the PEDIMENTO) where it declares the Shipper as the CRO / Sponsor and the Consignee as the Central Lab

 

A final note — the regulations in Mexico do not require an Export Permit for Plasma and Urine samples.

Even though the Pedimento can be reduced to one-page document, the instructions for completion are lengthy, and tend to be complex.  QuickSTAT's logistics team understands the local laws and regulations and can help simplify and expedite the process of completing the PEDIMENTO.

Contact Our Experts with questions regarding export or import of biological samples from Mexico, or any part of the world.

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About Leo Harcha
Director of Latin American Operations

Leo has over 20 years of LATAM operational logistics management experience, and has been been involved in the development of the LATAM region transportation solutions, as well as a service partner and depot network. Leo... Read more.

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