Regulatory Framework · 2.4 Substance Market Regulations

Partial compliance.

Mexico has a solid legal architecture for controlled-substance traceability. The General Health Law establishes controls over narcotics, psychotropics, and medicines containing them, including special prescriptions, dispensing, authorized establishments, control books, importation, exportation, and sanitary documentation. The Health Supplies Regulation complements this framework with administrative rules for establishments, prescriptions, medicine handling, and documentary records.

The most specific source in the evidence block is the Federal Law for the Control of Chemical Precursors, Essential Chemicals, and Machines for Manufacturing Capsules, Tablets, and/or Pills. This law incorporates obligations for activity reporting, operator identification, volume control, transportation, authorizations, and use of the Integrated Substances System. This shows that Mexico has not only general sanitary-control rules, but also a specific framework for tracking substances and materials linked to diversion risk.

There is also operational-programmatic evidence through COFEPRIS’s Integrated Substances System and COFEPRIS-Navy coordination. These sources document a federal platform aimed at procedures, control, registration, and surveillance of regulated substances. However, the existence of the platform is not enough to establish effective end-to-end traceability.

The indicator does not reach full compliance because the available evidence does not demonstrate verifiable national system performance. Public evidence does not confirm real coverage, data quality, inter-agency interoperability, alerts, audits, inspections, sanctions, diversion reduction, end-to-end traceability, or state-level results. Mexico City, Puebla, Oaxaca, Chiapas, and the complementary states remain territorial probatory gaps regarding Integrated Substances System performance, inspections, sanctions, alerts, and effective control.

Consequently, Mexico demonstrates an important legal and administrative basis for registering, controlling, and monitoring regulated substances, but not sufficient evidence of homogeneous, interoperable, evaluated, and effective national traceability.