Spain opens up access to medical cannabis for four specific pathologies

Spain has finally seen medical cannabis before France. After the validation last October of the royal decree authorizing medical cannabis, the Spanish Medicines and Healthcare Products Agency (AEMPS) has just published a framework setting out the rules for the indications, dosage, administration and monitoring of medical cannabis.

Four indications and strict oral administration

According to the AEMPS monograph, the medical marijuana can only be prescribed in Spain for four indications: chronic pain, spasticity associated with multiple sclerosis, severe forms of epilepsy and chemotherapy-related nausea and vomiting.

According to Público, «medical cannabis will be administered orally in Spain, in doses determined by the doctor for each patient, which may in no case exceed 32 milligrams per day, and initially for four indications only».

The decision to limit administration to oral solutions excludes flowers and inhaled forms, This choice is justified by the authorities as a means of standardizing dosage and reducing variability. Prescriptions are also restricted to specialist physicians, reinforcing a highly controlled medical pathway.

Individualized THC dosage and limits

Given the limited clinical data available, AEMPS has opted for an individualized approach to dosing. Physicians are instructed to start with the lowest possible dose and gradually increase it until therapeutic effects are observed.

The monograph sets a strict ceiling: no more than 32.4 milligrams THC or 25 milligrams of CBD per day. Pediatric use is even more restrictive, with THC doses capped at 10 milligrams for chemotherapy-related nausea and just 0.6 milligrams for other indications. Health authorities also recommend CBD-dominant formulations wherever possible, due to concerns about THC's impact on neurocognitive development.

As stated, «due to the lack of data to establish a dosage recommendation, the Spanish Agency for Medicines and Health Products (AEMPS) has determined that doses should be individualized for each patient».

Safety, contraindications and monitoring

The monograph details a wide range of precautions. Patients are advised not to drive or operate machinery until they understand how the treatment affects them, as dizziness and drowsiness are common side effects. Particular caution is advised for people with cardiovascular disorders, as cannabis preparations can cause hypotension, hypertension or tachycardia.

Contraindications include pregnancy, breast-feeding, hypersensitivity to components of the formulation and a personal or family history of psychotic disorders. Interactions with benzodiazepines and alcohol are also highlighted, with warnings about additive sedative effects and impaired coordination.

Monitoring treatment is a shared responsibility between prescribing physicians and hospital pharmaceutical departments, who must regularly assess efficacy and adverse effects.

A limited opening for a major producer country

Despite this regulatory breakthrough, the Spanish medical cannabis industry remains largely export-oriented. According to Cannamonitor, the country has approximately 70 medical cannabis companies, With 147 million euros invested and 34 million euros of sales recorded in 2023. In 2025 alone, over eight tonnes of cannabis flowers were exported, mainly to Germany and Great Britain.

Industry representatives claim that the new framework benefits only a small part of the sector. Members of the Spanish Association of Medical Cannabis Companies (AECAME) estimate that up to 90% of companies remain excluded due to restrictions on formats, prescriptions and distribution channels.

The Ministry of Health insists, however, that the regulations are designed to evolve. «The standard responds to the need to offer a therapeutic alternative in cases where conventional treatments are ineffective,» it said when announcing the decree.

For patients, this change represents cautious progress. For Spain's cannabis ecosystem, it's a tightly controlled first step towards a national medical market that has long existed in theory, but not yet in practice.