UPDATE (DECEMBER, 2016):
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.
The Mexican Tax Authority (SAT) has revised the new CFDI export reporting regulations, that require electronically filed commercial invoices to accompany exported goods. SAT clarified that the paragraph 3.1.35 of the 2016 General Foreign Trade Rules applies to commercial products exported from Mexico, as defined by the Article 14 of the Foreign Trade Rules.
Since Biological Samples are not a commercial product, they do not fall under the Article 14 and are therefore excluded from the new regulations. CROs in Mexico are not required to accompany exports of biological samples by a legal Commercial Invoice processed by the Tax Authority (SAT).
The new regulations (paragraphs 3.1.35 and 3.1.36 of the General Rules for Foreign Trade 2016 issued by DOF) effective July 1, 2016 were initially believed to have implications for local CROs and brokers in Mexico. Facing potential shipment delays when exporting biological samples ( since only CRO employees would be able to generate the commercial invoices) local CROs and brokers have been sending inquiries to the Customs Authorities and the Service Tax Administration office to address the issues.
If you have questions about the regulations or require further clarification, please Contact Our Experts and we will contact you with additional details.