Regulatory Hierarchy

Workflow steps

1. COFEPRIS — Comisión Federal para la Protección contra Riesgos Sanitarios
   Primary regulatory authority for cannabis in Mexico. Under SADER (Secretaría de Agricultura) and MOH (Secretaría de Salud). Issues import authorizations, manufacturing permits, and sanitary registrations. Per-shipment import authorizations required.
   • Import authorizations (per-shipment)
   • Manufacturing permits
   • Sanitary registrations
   • BPF (Mexican GMP) oversight
2. Secretaría de Salud — Ministry of Health — policy oversight
   Sets national health policy including cannabis. 2017 constitutional reform allowed medical use. 2021 Supreme Court declared recreational prohibition unconstitutional — regulatory framework for adult-use still developing as of 2026.
   • Medical cannabis policy framework
   • Constitutional reform implementation
   • Adult-use regulatory development
3. Licensed Importers / Manufacturers — Growing sector
   Licensed cannabis importers and manufacturers operating under COFEPRIS authorization. Major bilateral agreement with Canada — import of Health Canada-licensed products is established.
   • COFEPRIS import authorization
   • COFEPRIS manufacturing permit
   • BPF (Mexican GMP) compliance
   • Health Canada-licensed products (via bilateral)
4. Pharmacies — Dispensing
   Licensed pharmacies dispense medical cannabis products. Patient access via specialist prescription required.
   • Pharmacy license with cannabis scope
   • Specialist prescription required
   • Patient record-keeping
   • COFEPRIS product registration
5. Patients — End recipients
   Mexican patients access medical cannabis via specialist prescription. Access pathway established by 2017 constitutional reform. Adult-use regulatory framework still developing.