Spain legalizes medical cannabis!

Spain has officially joined the medical marijuana in its national health care system. The October 7, 2025, the Cabinet approved a royal decree which establishes the regulatory framework for the preparation and prescribing of master formulas derived from standardized cannabis-based preparations.

This measure, proposed by the Ministry of Health, aims to offer a therapeutic alternative to patients who do not respond adequately to conventional treatments. Eligible conditions include chronic, intractable pain, thesevere epilepsy and the spasticity caused by multiple sclerosis, conditions for which existing medications are often insufficient.

Strict medical and pharmaceutical oversight

By virtue of of the new regulations, only the specialists will be authorized to prescribe compounded cannabis-based medications, which must be prepared and dispensed exclusively through hospital pharmacies. Each prescription will be subject to individualized clinical monitoring, ensuring that the treatment remains under continuous medical and pharmaceutical supervision.

These preparations must come from’standardized cannabis extracts registered with the AEMPS (Spanish Agency for Medicines and Health Products). The Cannabis flowers, on the other hand, will not be included requirements.

In practice, this measure incorporates cannabis-derived products into Spain’s existing pharmaceutical monitoring system, with no possibility of distribution outside of hospital settings.

An evidence-based framework and evolving guidelines

The Royal Decree does not define a fixed list of approved indications. Instead, it introduces a dynamic model based on scientific evidence. The AEMPS will publish within three months monographs detailing authorized clinical uses, formulation standards, and prescribing protocols. These monographs, which are part of the National Form, will be updated periodically as new evidence and clinical data become available.

This flexible approach reflects the government's intention to implement a scalable framework that can adapt as research progresses. It leaves open the possibility that future conditions, supported by solid scientific evidence, may also benefit from cannabis-based treatments.

Although cannabis is a substance subject to international control, Spanish authorities recognize the growing scientific support for its use in specific cases. Research validated by international health organizations has demonstrated its therapeutic potential in the treatment of spasticity associated with multiple sclerosis, and treatment-resistant epilepsies, and chemotherapy-induced nausea and vomiting and chronic pain.

Monitoring, Traceability, and Patient Safety

All cannabis-based preparations used in compounded formulations will be listed in a public registry managed by the’AEMPS, ensuring transparency and traceability throughout the supply chain. Each registered product must declare its precise THC and CBD content, comply with strict manufacturing requirements, and undergo a additional monitoring if it exceeds 0.2% of THC.

Manufacturers and laboratories will be required to maintain complete documentation and implement audit processes to ensure pharmaceutical-grade production and appropriate distribution. The decree also requires a pharmacovigilance continuous, meaning ongoing monitoring of patients' responses, side effects, and long-term effectiveness.

The regulations also recognize the need for equitable access. In exceptional cases, such as patients with vulnerable situation or those living in remote areas, regional health authorities may authorize mechanisms for remote issuance.

By approving this decree, Spain joins the other European countries that have already implemented regulatory frameworks for medical cannabis. The government describes this initiative as a commitment to more personalized, evidence-based medicine, ensuring that patients receive scientifically validated treatments under the supervision of professionals.