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Regulatory Hierarchy

Chilean regulatory structure from Ministry of Health to patient

Regulatory Structure Verified 2026-04-20

Workflow steps

  1. Ministry of Health — Ministerio de Salud (Minsal)
    Sets national medical cannabis policy under Ley 21.020. Oversees ISP and SEREMI. Chile has a well-established medical cannabis framework since 2017.
    • National cannabis policy under Ley 21.020
    • Oversight of ISP pharmaceutical regulation
    • Patient access guidelines
  2. ISP — Instituto de Salud Pública
    Public Health Institute. Primary regulatory authority for medical cannabis. Issues import authorizations, manufacturing licenses, product registrations, and GMP certification. Manages cannabis-specific registry.
    • Import authorization per shipment
    • Manufacturing and GMP certification
    • Product registration (Registro Sanitario)
    • Cannabis-specific regulations under Ley 21.020
  3. SEREMI — Secretaría Regional Ministerial de Salud
    Regional Ministerial Secretariats of Health. Implement ISP policy at regional level. Conduct pharmacy inspections and enforce controlled substance regulations at the local level.
    • Regional enforcement of ISP regulations
    • Pharmacy inspections
    • Controlled substance monitoring
  4. Licensed Producers — Growing sector
    Chile's domestic cannabis production sector is expanding. Several licensed producers operate under ISP oversight for both domestic supply and emerging export ambitions. Magistral preparation pathway supports compounding pharmacies.
    • ISP manufacturing license
    • GMP certification (ISP/Chilean GMP)
    • GACP certification for cultivation sites
  5. Patients — Medical cannabis access
    Patients access medical cannabis through medical prescription. Chile permits magistral preparation (compounding) as the primary access pathway, alongside registered pharmaceutical products.
Import Authorization