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Regulatory Update: New CFDI Export Regulations in Mexico in Logistics Blog



UPDATE (February, 2017):

Mexico's Tax Authority (SAT) has confirmed that the CFDI (electronic invoice process) will be mandatory for the export of patient samples from Mexico effective March 1, 2017. The following process will be required:  


1. Exporter (CRO and/or Pharmaceutical Company) submits a digital invoice via internet (CFDI) to SAT with all pertinent information including income (sale) or transfer (non-sale) 


2. PAC (Companies who are authorized by SAT to process electronic invoices) receive the invoice back from SAT with a unique certificate number  


3. Broker will present the invoice with the certificate number when creating the Pedimento. The invoice must be present in the SAT system or the Pedimento will be denied. 


If the invoice is generated with the incorrect sample/vial/tube information, there can be a delay in revising the invoice since it can only be modified by the CRO, unless proper authorizations is given to the broker to process the invoice on their behalf.


Note: Brokers and CROs in Mexico are still engaged with the Mexican Authorities to exclude Biological Samples from this regulation, as they have no commercial value. 


QuickSTAT is working closely with our customs broker, CROs, and sponsors to ensure that we are in communication with SAT to stay updated on their decision and timeline for the implementation of the electronic invoice process in Mexico.




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Mexico's Tax Authority (SAT) has decided to revisit their stance on whether the export of patient specimens will require the use of the electronic invoice system. They are now considering March 1, 2017 as the implementation date for the electronic invoice process if they decide to move forward with its application to patient samples. 


Initially, SAT clarified paragraph 3.1.35 of the 2016 General Foreign Trade Rules stating that biological samples are not a commercial product and do not fall under Article 14, therefore they are excluded from the new regulations. 


SAT has not officially confirmed that the electronic invoice process will need to be used for the export of patient samples from Mexico as yet.

QuickSTAT is working closely with our customs broker, CROs, and sponsors to ensure that we are in communication with SAT to stay updated on their decision and timeline for the implementation of the electronic invoice process in Mexico.


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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 has created... Read more.
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