The document outlines the removal of review requirements for self-managed Notices submitted to COFEPRIS, outlines continued regulatory oversight, specifies exceptions, and highlights the move toward digital transformation.
This document covers the following information:
- Elimination of express review and approval for most Notices submitted to COFEPRIS
- Clarification that Notices are now considered self-managed procedures
- Equal legal validity for physical and electronic submissions through corresponding acknowledgments of receipt
- Continued responsibility for regulated entities to comply with all relevant health regulations
- Ongoing verification, surveillance, and sanitary control actions by COFEPRIS after submission
- Potential for sanctions and security measures if irregularities or inconsistencies are found in submitted information
- Exceptions for specific import and export Notices, which will continue to require review until technical adjustments are implemented
- Collaboration with the Digital Transformation and Telecommunications Agency to promote good regulatory practices and reduce bureaucracy without compromising public health
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