Overview

• Prescriptions will be limited to hospital specialists, with compounding and dispensing restricted to authorized hospital pharmacies under a new AEMPS registry and extra controls for products over 0.2% THC.
• AEMPS is tasked with setting the authorized clinical uses and technical rules through National Formulary monographs on a three‑month timeline.
• The decree avoids a closed list of indications, citing evidence for multiple sclerosis–related spasticity, severe refractory epilepsy, chemotherapy‑induced nausea and vomiting, and refractory chronic pain.
• Laboratories must ensure quality manufacturing, distribution, and audited supply chains, and treatment monitoring will be shared by the prescriber and hospital pharmacy with periodic efficacy and safety evaluations.
• Spain’s pharmacists’ council criticized the hospital‑only dispensing model, arguing community pharmacies could safely supply these formulations and improve access for chronic patients.