The Spanish Council of Ministers approved the Royal Decree regulating the use of magistral formulas made from standardized cannabis preparations. The proposal, presented by the Ministry of Health, meets a request from the Congress of Deputies and represents a decisive step towards integrating the treatment into the healthcare system.

According to the announcement, the new regulation aims to ensure the use of medical cannabis with scientific, clinical, and sanitary support.

Evidence-based regulation of medical cannabis

The Royal Decree does not establish a list of indications. Authorized clinical uses will be defined in monographs published by the Spanish Agency of Medicines and Medical Devices (AEMPS), allowing continuous updates based on new scientific advances.

Cannabis is a substance subject to international control. However, scientific evidence endorsed by global organizations has demonstrated its benefits for conditions such as multiple sclerosis, refractory epilepsy, chemotherapy-associated nausea, and chronic pain.

For these cases, medical cannabis formulations emerge as a therapeutic alternative when traditional medications are insufficient, always under strict medical and pharmaceutical supervision.

Prescription and control of medical cannabis

Medical cannabis formulations must be prescribed exclusively by specialist physicians in a hospital setting, with documented clinical justification. Preparation will be restricted to authorized hospital pharmacy services, following rigorous technical standards.

The decree also establishes a public registry, managed by the AEMPS, for all standardized cannabis preparations. These products will have a defined composition of THC and/or CBD and will comply with stringent manufacturing, traceability, and quality requirements.

Clinical monitoring and safety

Treatment monitoring will be a joint responsibility between the physician and the hospital pharmacist, who will assess effectiveness and potential adverse effects. Autonomous communities may establish remote dispensing mechanisms to ensure equitable access to treatment.

With this regulation, the government reaffirms its commitment to a more personalized and safe medicine. The measure provides an evidence-based alternative for patients who do not find an effective response in conventional medications, consolidating the role of medical cannabis in public health.