Regulatory Framework · 2.2 Access to Controlled Medicines

Full compliance with the object of the indicator.

Mexico has a strong, specific, and current federal legal framework for regulating psychotropic medications. The General Health Law classifies psychotropic substances, establishes differentiated controls, and regulates medical prescription, sale, supply, importation, exportation, authorized scientific research, and sanitary surveillance. COFEPRIS complements this framework through procedures, notices, permits, and authorizations applicable to narcotics, psychotropics, and other substances subject to sanitary control.

The evidence block is also supported internationally through the 1971 Convention on Psychotropic Substances and the international control mechanisms of the International Narcotics Control Board, placing Mexico’s regulatory regime within the international system governing lawful psychotropic-substance control.

The reviewed evidence does not establish homogeneous enforcement across the entire territory, complete traceability, absence of diversion, or uniform inspection outcomes across pharmacies, distributors, and federal entities. Subnational probatory gaps also remain in some territories.

However, those limitations concern the effectiveness and uniformity of regulatory implementation. I48 assesses the existence and configuration of the regulatory regime governing psychotropic medications, and that object is fully demonstrated through current legislation and operational administrative mechanisms. The indicator is therefore classified as green. Factor X does not apply.