Import Authorization

Workflow steps

1. Import Intent
   COFEPRIS issues import authorizations on a per-shipment basis. Requires sanitary registration or special authorization. Major bilateral agreement with Canada — import of Health Canada-licensed products is established. Patient access via specialist prescription.
   • COFEPRIS import authorization (per-shipment)
   • Sanitary registration or special authorization
   • Health Canada-licensed products (bilateral)
   • Specialist prescription for patient access
2. COFEPRIS Import Authorization
   Apply to COFEPRIS for per-shipment import authorization. Sanitary registration of the product in Mexico is typically required, or special authorization for unregistered products. Canada bilateral: Health Canada-licensed products have established import pathway.
   • COFEPRIS import authorization application
   • Sanitary registration (or special auth)
   • Product COA and specifications
   • Exporting country export permit
   • Bilateral: Health Canada license reference (Canada)
3. Authorization granted?
   COFEPRIS evaluates import application. Per-shipment basis means each import requires separate authorization. Bilateral agreement with Canada streamlines Canadian product imports.
4. Address COFEPRIS Queries
   Respond to COFEPRIS requests. Common issues: missing sanitary registration, insufficient product documentation, or end-use justification gaps.
   • Additional product documentation
   • Sanitary registration application (if missing)
   • End-use justification
5. Mexican Customs
   Customs clearance at Mexico City (MEX), Guadalajara (GDL), or other ports. COFEPRIS authorization must be presented. Narcotic import declaration under Single Convention 1961.
   • COFEPRIS import authorization (original)
   • Exporting country export permit
   • COA per batch
   • Customs narcotic declaration
6. Import Cleared ✓
   Product released for authorized use in Mexico. Patient access via specialist prescription. Canada bilateral agreement facilitates significant import volume.