Clinical experience and scientific rigor applied to Medical Cannabis

Yes. Royal Decree 903/2025 governs the therapeutic use of Medical Cannabis in Spain under specialist medical prescription within the National Health System (SNS). The statutory framework is supplemented by the AEMPS National Formulary monographs, which standardize the preparation of standardized Cannabis compounding formulations (THC, CBD) in oral oil solutions. Spain aligns with the most stringent European clinical models, prioritizing patient safety, pharmaceutical traceability, and legal certainty for the prescribing physician.

RD 903/2025 comprehensively defines the full clinical and regulatory framework for Medical Cannabis in Spain:

• Authorized standardized compounded formulations and permitted dosage forms
• Qualified medical specialists authorized to prescribe Medical Cannabis and common clinical indications
• The complete healthcare circuit: from clinical specialist evaluation to hospital pharmacy compounding and dispensing
• Mandatory pharmacovigilance reporting and professional medico-legal responsibilities of the prescriber
• The AEMPS National Formulary monographs (FN 2026 FMT 043), establishing the composition, preparation method, storage parameters, and safety profile of standardized Cannabis preparations (THC, CBD) in oral solution

The AEMPS has incorporated into the National Formulary the monograph for standardized Cannabis preparations (THC, CBD) in oral solution (FN 2026 FMT 043). This is the binding technical document defining quantitative composition, compounding methodology, packaging, shelf-life, clinical indications, posology, and adverse event profiles.

It represents the mandatory reference for Hospital Pharmacy Departments responsible for compounding and dispensing Medical Cannabis in Spain, marking a pivotal milestone: the AEMPS may introduce new standardized formulations and expand indications as scientific evidence progresses.

Prescription is restricted exclusively to medical specialists practicing within public hospitals of the National Health System (SNS) or accredited affiliated healthcare centers. The specialties most frequently involved in prescribing Medical Cannabis in Spain are neurology, medical oncology, pain management units, and palliative care. Primary care physicians and non-accredited private practitioners are excluded during this initial regulatory phase, unless specific institutional authorization is granted.

Royal Decree 903/2025, together with AEMPS National Formulary monographs (FN 2026 FMT 043), currently authorizes 4 clinical conditions supported by Level A-B clinical evidence:

• Multiple sclerosis spasticity (moderate to severe) refractory to first-line pharmacotherapies
• Chemotherapy-induced nausea and vomiting (CINV) refractory to standard antiemetic protocols
• Severe refractory epilepsies — Dravet or Lennox-Gastaut syndromes with failure of ≥2 antiepileptic drugs
• Refractory chronic pain (neuropathic or cancer-related) with failure of ≥2 therapeutic lines

This framework is dynamic: the AEMPS has statutory authority to introduce additional standardized formulations and expand recognized indications as clinical trials and real-world evidence mature.

The AEMPS National Formulary monograph (FN 2026 FMT 043) specifically standardizes standardized Cannabis preparations (THC, CBD) in oral oil solutions, prepared exclusively within Hospital Pharmacy Departments using certified active pharmaceutical ingredients (APIs) of verified pharmaceutical grade, with defined, reproducible cannabinoid titers.

Any alternative pharmaceutical formulation requires individual compounding validation under the technical oversight of the hospital pharmacy service.

Dosage forms NOT permitted under this decree: dried flowers/flos for inhalation/vaporization, topical compounded products, and edible formulations. Prescribing outside the established framework incurs professional medico-legal liability.

RD 903/2025 establishes two mandatory clinical documents prior to issuing any prescription for Medical Cannabis in Spain:

• Specific Informed Consent Form: signed by the patient and the physician, conforming to the template approved by the hospital's Clinical Research Ethics Committee
• Clinical Justification Report: a detailed medical record documenting clinical refractoriness to authorized lines, a documented benefit-risk evaluation, and the defined therapeutic monitoring plan

Thorough documentation serves as the primary legal and professional safeguard for the prescribing physician.

Compassionate use allows exceptional access to Medical Cannabis in Spain for conditions outside the officially designated indications, specifically in severe, life-threatening, or chronically debilitating diseases lacking satisfactory therapeutic alternatives. The procedure requires:

• Detailed clinical justification and formal application by the treating specialist
• Specific compassionate-use informed consent form
• Formal approval by the hospital's Pharmacy and Therapeutics Committee (CFT)
• Official notification submitted to the AEMPS by the hospital administration

Royal Decree 903/2025 and monograph FN 2026 FMT 043 of the AEMPS National Formulary define the following absolute contraindications for Medical Cannabis:

• Pregnancy and breastfeeding
• Active psychosis or a documented personal history of psychotic disorders (e.g., schizophrenia, bipolar disorder in manic phase)
• Known hypersensitivity to cannabinoids or excipients (e.g., MCT carrier oil)
• Severe hepatic impairment (Child-Pugh Class C) or uncompensated severe cardiovascular disease
• Patients under 18 years of age, except in approved pediatric refractory epilepsies managed with purified CBD

Specialists prescribing Medical Cannabis in Spain must report adverse drug reactions through the Yellow Card system of the Spanish Pharmacovigilance System (SEFV-H) via notificaram.es:

• Serious adverse reactions (resulting in death, hospitalization, or persistent disability): mandatory reporting within 24 to 48 hours
• Non-serious and unexpected adverse reactions: reporting within a maximum period of 15 calendar days
• Suspected lack of therapeutic efficacy during Medical Cannabis therapy

The National Formulary monograph (FN 2026 FMT 043) also establishes specific safety precautions and monitoring parameters for standardized oral solutions.

The prescribing specialist carries a legal obligation to counsel the patient on this matter. Spanish Traffic Law penalizes the detectable presence of THC in oral fluid (saliva) on a zero-tolerance basis, without legal distinction between medicinal and non-medicinal use. Monograph FN 2026 FMT 043 explicitly highlights the neurocognitive impact of THC on operating motor vehicles. Specialists must instruct:

• Strict avoidance of driving during the initial dosage titration phase of Medical Cannabis
• An individualized driving abstention period following administration, calibrated to prescribed dosage, tolerance, and pharmacokinetics
• Carrying formal medical documentation and the active specialist prescription at all times

Compounded preparations of Medical Cannabis in Spain are compounded exclusively in Hospital Pharmacy Departments, utilizing certified pharmaceutical-grade active ingredients in compliance with monograph FN 2026 FMT 043 of the AEMPS National Formulary. This system ensures:

• Accurate, reproducible cannabinoid concentrations (titrated THC and CBD ratios)
• Stringent analytical screening for contaminants: heavy metals, pesticide residues, and microbial bioburden
• End-to-end pharmaceutical traceability from raw materials to patient administration
• Formal pharmaceutical validation prior to patient dispensing

The hospital pharmacist is a cornerstone of the healthcare circuit regulated by RD 903/2025. Responsibilities include:

• Compounding standardized formulations in compliance with the AEMPS National Formulary monograph
• Overseeing quality control, pharmaceutical release testing, cold-chain/storage compliance, and shelf-life monitoring
• Performing technical and pharmacological validation of medical prescriptions prior to dispensing
• Dispensing medication directly to patients with pharmaceutical counseling, and actively participating in pharmacovigilance

This oversight provides technical assurance that formulations precisely meet established therapeutic specifications.

These represent distinct regulatory categories under Spanish and European pharmaceutical law:

• Standardized compounded Medical Cannabis preparations (the core of RD 903/2025): customized hospital preparations for individual patients with flexible THC:CBD ratios, compounded under AEMPS National Formulary monographs, Royal Decree 1015/2009, and the 1971 UN Convention on Psychotropic Substances
• Manufactured industrial pharmaceuticals such as Sativex® or Epidiolex®: authorized through standard AEMPS/EMA marketing authorization procedures with fixed active dosages and specific closed indications, separate from the newly regulated compounding framework

Our Medical Cannabis training program in Spain is designed specifically for medical specialists within the National Health System (SNS) and affiliated centers seeking to incorporate cannabinoid therapies into clinical practice with scientific rigor, clinical precision, and full medico-legal compliance under RD 903/2025. It is especially pertinent for specialists in neurology, medical oncology, pain management, and palliative medicine, as well as hospital pharmacists overseeing compounding and dispensing.

Receta Cannabis has been a clinical leader in Medical Cannabis since 2017, with over 9 years of active medical practice and more than 27,000 patients monitored under structured clinical protocols. As the platform with the deepest clinical experience in cannabinoid therapeutics in Latin America, this validated real-world clinical data serves as the foundation for our educational program in Spain.

The Medical Cannabis training program in Spain is currently in its pre-registration phase. Register today to receive priority notifications regarding start dates, eligibility criteria, and enrollment details. Enrollment is capped to ensure high-quality clinical mentorship.