COFEPRIS announced the publication of an Agreement in the Diario Oficial de la Federación (DOF) introducing regulatory simplification measures for procedures related to narcotics, psychotropics, chemical precursors, and essential chemicals. The update aims to optimize the sanitary regulatory framework and advance digital transformation across controlled-substance regulatory pathways.
The Agreement strengthens traceability and sanitary control by reducing administrative burden, harmonizing technical criteria for regulated establishments, and enabling the transition toward digital processing through SISUS and updated homoclaves. The Agreement enters into force 30 business days after publication in the DOF.
Key Highlights
- Regulatory Simplification Measures
Eliminates 44 mandatory physical requirements and consolidates 18 homoclaves into 13, supporting faster and more predictable processing. - Digital Registration via SISUS (COFEPRIS-03-022)
Implements digital registration for essential chemical products through the COFEPRIS-03-022 homoclave in the Sistema Integral de Sustancias (SISUS). - New Homoclave for Authorizations (COFEPRIS-03-021)
Establishes COFEPRIS-03-021 for authorizations related to the use or commercialization of narcotics and psychotropics. - Implementation and Transition Timeline
Once the corresponding digital tools become operational, applicable procedures will migrate entirely to the new scheme. The Agreement becomes effective 30 business days after its DOF publication. - Operational Impact for Regulated Establishments
Relevant for establishments handling controlled substances for industrial, medical, and scientific activities, improving regulatory traceability and supporting compliance through digital modernization.
This update reinforces COFEPRIS’ commitment to strengthening the sanitary regulatory framework for the lawful use of controlled substances while improving efficiency and transparency through digital tools.
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