- AEMPS — Agencia Española de Medicamentos y Productos Sanitarios
Primary medicines regulator. Issues import authorizations, manages GMP certification, oversees pharmaceutical-grade cannabis access. Spain's EU-GMP enforcement authority.
- Import authorizations for pharmaceutical-grade cannabis
- EU-GMP certification and inspections
- Pharmacovigilance
- Narcotic import/export licensing
- Ministry of Health — Ministerio de Sanidad
Sets national cannabis access policy. Oversees AEMPS. Spain permits magistral preparation (Fórmula Magistral) as the primary patient access pathway — no nationally authorized cannabis medicines beyond Sativex.
- National medicinal cannabis policy
- Oversight of AEMPS
- EU treaty obligations
- Authorized Importers — Licensed cannabis importers
Importers licensed by AEMPS to bring in pharmaceutical-grade cannabis for magistral preparation. Must hold EU-GMP compliant wholesale authorization.
- AEMPS wholesale authorization
- EU-GMP Part I compliant supply chain
- Per-shipment import authorization from AEMPS
- Pharmacies (Fórmula Magistral) — Compounding pharmacists — PRIMARY access pathway
THE PRIMARY patient access pathway in Spain. Pharmacies compound cannabis formulations (Fórmula Magistral) from imported pharmaceutical-grade cannabis, against physician prescriptions. Not a dispensing model — a compounding model.
- Spanish pharmacy license
- Magistral preparation capability
- Physician prescription required
- Narcotic dispensing register
- Patients — End recipients
Receive cannabis via magistral preparation at pharmacies. Sativex is the only nationally authorized cannabis medicine. Cannabis clubs operate in legal grey area (Barcelona, Catalonia) — NOT the official pathway.