The Spanish Government has approved a Royal Decree regulating the use of cannabis preparations in hospital care and under specialist prescription. In the next three months, the Spanish Agency of Medicines and Medical Devices (AEMPS) will establish the clinical indications, along with the specific conditions for preparation, dosage and prescription.
The decree also creates a public register, managed by the AEMPS, for standardized cannabis preparations manufactured by laboratories. These laboratories will be obliged to ensure strict controls on THC/CBD content, production quality and traceability.
The follow-up of the treated patients will be shared by the prescribing physician and the hospital pharmacy service, which must periodically assess the clinical effectiveness and the occurrence of possible adverse effects.
More information (in Spanish): Ministry of Health press release https://www.sanidad.gob.es/gabinete/notasPrensa.do?id=6761; Royal Decree 903/2025 https://boe.es/diario_boe/txt.php?id=BOE-A-2025-20077