Marken Export Compliance Update: Clinical Samples from Mexico


Ensuring delivery of clinical samples to labs outside of Mexico are on time and within temperature spec. requires close attention to, and compliance with, current export regulations.

Exports of clinical samples from Mexico are subject to specific export controls and reporting requirements. Mexico’s General Foreign Trade Rules, sections 3.1.127 states that human sera and tissue samples may only be exported from Mexico when either of the following conditions are met.

  • Under an export permit issued by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios or,
  • As samples classified under 9801.00.01 and covered under an approved study protocol

In order to ensure these export requirements are met, Trade Regulations require that each export shipment be reported to Customs under an individual export pedimento, and that they are made in the name of the exporter identified on the permit or approved named on the approved study protocol.

When shipping clinical samples it is critically important for sites to ensure their designated agents and brokers are compliant with the requirements noted above. Any clearance procedure that does not comply with these requirements may lead to export clearance delays and other serious problems.

The use of consolidated export pedimentos, commonly used for clearing express consignment shipments and other general merchandise, is expressly not permitted for the export of clinical samples.

Exports of clinical samples from Mexico are highly scrutinized by Customs and exporters found not complying with Mexico’s Trade Regulations can may be subject to heavy fines & penalties. These penalties may include the suspension of export privileges, resulting in serious implications for ongoing clinical studies.

We recommend that local operations and customer service staff work closely with clinical sites and exporters to ensure a thorough understanding of their obligations and compliance with export regulations.

For additional information or questions regarding this update, please contact:

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