Medicinal cannabis in Spain

Last Tuesday, the Council of Ministers approved the Royal Decree 903/2025 establishing the conditions for the preparation and dispensing of standardized medicinal cannabis prescriptions, which regulates for the first time the medicinal use of cannabis in Spain. This regulation creates a specific framework for the prescription, preparation, dispensing, and monitoring of magistral prescriptions (fórmulas magistrales) based on standardized cannabis preparations.

Until now, Spain lacked a system allowing for systematic, safe, and supervised access to cannabis-based medicinal products. Clinical practice was limited to the use of authorized medicines for specific indications, while cannabis-based formulas operated in a regulatory legal void, despite the existence of cultivation licenses and research activities under the supervision of the Spanish Agency for Medicines and Health Products ("AEMPS") and the international control of cannabis as a narcotic. Meanwhile, the cannabidiol market("CBD") has coexisted with authorized cosmetic uses and consumer practices for unapproved indications, outside the healthcare circuit and without medical supervision.

Main developments introduced by the Royal Decree

• The Royal Decree authorizes the use of standardized magistral prescriptions made from cannabis preparations when existing treatments have proven insufficient, such as for:
• spasticity associated with multiple sclerosis;
• certain forms of refractory epilepsy;
• nausea and vomiting induced by chemotherapy; and
• refractory chronic pain.

Unlike earlier drafts that explicitly limited use to these four indications, the Royal Decree establishes an open framework for additional authorized clinical uses, which will be further specified in the monographs to be published by the AEMPS.

• Preparation is restricted to authorized hospital pharmacy services, and prescription is limited to specialist physicians in the relevant pathologies, with prior documented clinical justification.
• The preparations must specify a defined composition of tetrahydrocannabinol ("THC") and/or CBD. Products containing more than 0.2% THC will be subject to additional oversight, reinforcing control and traceability guarantees.
• The AEMPS will manage a public registry of standardized cannabis preparations eligible for use in magistral prescriptions and will require compliance with standards of proper manufacturing, distribution, traceability, and supply chain auditing.
• The regulation also establishes a shared clinical monitoring system between the prescribing physician and the hospital pharmacy service to assess efficacy and adverse effects periodically.

Impact on patients, healthcare professionals, and other stakeholders 

For patients, the Royal Decree opens formal, safe, and supervised access to cannabis-based therapies in cases where available alternatives have proven ineffective. The exclusive use within the hospital setting and under specialist medical supervision enhances clinical safety and consistency, though it will likely concentrate demand within hospital pharmacy services. Individualized assessment and periodic follow-up will allow for real-time dosage adjustments and evaluation of the benefit-risk balance.

For healthcare professionals, the limitation of prescription rights to specialists entails heightened clinical responsibility in both the indication and documentation of therapeutic need. This will require updated training in cannabinoid pharmacology, drug interactions, contraindications, pharmacovigilance, and in the use of the monographs to be issued by the AEMPS.

For hospital pharmacy services, the regulation introduces a new line of compounding activity under Good Compounding Practices, with stringent standards for quality, traceability, and auditing.

For the industry and authorized operators, the new framework opens the possibility of developing standardized cannabis preparations for hospital use, subject to AEMPS authorization and registration in the public registry.

Entry into force and technical implementation

The regulation will enter into force the day after its publication in the Official State Gazette ("BOE"). Within three months, the AEMPS must publish the monographs for the standardized magistral preparations that will govern clinical practice, including criteria for indication, composition, dosage, preparation conditions, and monitoring guidelines.

We now await the publication of these monographs in order to assess the implementation and practical operation of the new regulatory framework, as well as its real impact on patient care, hospital organization, and the activities of regulated operators.