Regulatory Hierarchy

Workflow steps

1. FAMHP — Federal Agency for Medicines and Health Products (AFMPS/FAGG)
   Primary regulator for all medicines including cannabis. Issues import authorizations, EU-GMP certificates, and manages the magistral preparation framework. Belgium is EEA — FAMHP is a major EU-GMP issuing authority and significant pharma manufacturing hub.
   • Per-shipment import authorizations
   • EU-GMP certification (EEA authority)
   • Wholesale dealer authorizations
   • Magistral preparation oversight
   • Pharmacovigilance
2. Ministry of Health — Policy oversight
   Sets national medicinal cannabis policy. Oversees FAMHP. Belgium permits cannabis access via authorized products (Sativex) and magistral preparation — a significant access pathway.
   • National cannabis access policy
   • Oversight of FAMHP
   • Loi coordonnée sur les médicaments framework
3. Magistral Preparation Pharmacies — Compounding pharmacists
   A SIGNIFICANT access pathway in Belgium. Pharmacists compound preparations from imported cannabis flower or extract under FAMHP-approved magistral preparation formulas. This is distinct from standard dispensing — the pharmacist is the manufacturer.
   • Licensed pharmacist with magistral preparation authorization
   • FAMHP-approved preparation formula
   • Cannabis sourced from FAMHP-authorized imports only
   • GDP and magistral preparation GMP compliance
4. Patients — End recipients
   Access via standard prescription (Sativex) or magistral preparation. Named-patient authorization (ATU-equivalent) also available. Belgium's magistral preparation pathway provides broader access than many EU countries.