Medical Cannabis in Spain: Towards a clear, safe and clinically effective regulatory framework
The recent incorporation of standardized cannabis preparations (THC and CBD) to the National Formulas Formulary represents a milestone in the history of medical cannabis in Spain, marking the beginning of a clear, safe and evidence-based regulatory framework. This advance -the result of the new Royal Decree 903/2025- offers a health and pharmaceutical response to the needs of patients who do not obtain relief with the conventional treatments available until now.
A necessary change: from ambiguity to technical-sanitary order
Until the approval of this decree, Spain did not have a specific regulation allowing the regulated prescription and preparation of medical cannabis within the public health system. The new regulation establishes, for the first time, a technical legal framework for master formulas of standardized cannabis preparations, including their specialized prescription, hospital preparation, official registration and quality control.
These preparations are defined as standardized cannabis extracts with a defined composition of THC and/or CBD, registered with the Spanish Agency of Medicines and Health Products (AEMPS) and prepared exclusively in authorized hospital pharmacies, under criteria of quality, traceability and pharmaceutical control similar to those of any medicine.
Fundamental clinical indications and evidence
Scientific evidence supports the therapeutic use of cannabinoids in several medical conditions where other treatments have proven to be insufficient or ineffective. Among the main indications are:
– Spasticity associated with multiple sclerosis.
– Severe forms of refractory epilepsy.
– Chemotherapy-induced nausea and vomiting.
– Chronic pain refractory to conventional treatments.
The regulation does not rigidly limit these indications, but authorizes the AEMPS to publish official monographs in the National Formulary specifying conditions, doses and clinical-pharmaceutical guidelines within a maximum period of three months. This allows the indications to be updated as science advances and clinical evidence increases.
Prescription and monitoring: safety as a priority
The Royal Decree stipulates that only specialist physicians may prescribe these formulations, guaranteeing that the therapeutic decision is based on clinical judgment with documented justification in the clinical history and clear communication of benefits and risks to the patient.
In addition, the preparation of the preparations will be carried out under the standards of correct pharmaceutical preparation, with qualified hospital pharmacy services, ensuring reproducibility, stability and predictable dosage for each patient.
Standardized products will be under a public registry managed by the AEMPS with traceability and control, especially for those containing more than 0.2% THC.
Impact on patients and healthcare professionals
This advance constitutes a substantial improvement in clinical practice in Spain, since:
– It facilitates homogeneous and regulated access to cannabinoid treatments within the health system.
– It protects patient safety by ensuring that formulations have pharmaceutical quality, standardized dosages and active pharmacovigilance mechanisms.
– It provides healthcare professionals with a clear framework for evidence-based prescribing in a context of rigorous health monitoring.
A technical step with great clinical potential
Although there are still challenges ahead – such as expanding clinical research, making access models more flexible in primary care or developing broader public health strategies – the regulation of standardized medical cannabis preparations in Spain is a historic step forward that aligns clinical practice with international standards of quality and therapeutic safety.
From MIVI Salud, as part of our commitment to clinical excellence and scientific evidence, we celebrate this step that promises to improve care for patients with refractory chronic pain, severe epilepsy and other conditions that need safe and effective therapeutic alternatives.
By Jesús De Santiago Moraga, MD, PhD, EDP – MIVI Salud
Director of MIVI Canary Islands Units