Curaleaf Says It Won Spain's First Medical Cannabis Registrations. AEMPS Is Silent

Spain's medical cannabis framework may have its first registered products. On July 13, Curaleaf announced that AEMPS, Spain's medicines agency, registered two of its standardized cannabis preparations. One is THC-dominant, registered as CAN-1. One is CBD-dominant, registered as CAN-2. The company said it believes it is the first to register under Spain's new rules.

One thing the announcement did not include: independent confirmation. As of this week, AEMPS's public cannabis-registration page explained how companies apply but did not visibly list CAN-1 or CAN-2. The agency issued no release of its own. Every report of the registration traces back to Curaleaf's press release.

What got registered, and what did not

The registrations fall under Royal Decree 903/2025, the framework Spain's government approved in October 2025.^[1] The decree does not create a retail market. Registered preparations are manufacturing inputs. They can be shipped to authorized hospital pharmacies, where pharmacists compound them into prescription-specific medicines called fórmulas magistrales tipificadas.

Under the decree, only specialist physicians can prescribe, and only when authorized industrial medicines do not exist or have failed a particular patient. Only hospital pharmacies can compound and dispense. Preparations with at least 0.2% THC by weight fall under Spain's psychotropic-substance controls.

Curaleaf's preparations came out of its EU-GMP facility in Alicante. The company did not announce a dispensing date, price, reimbursement deal, hospital contract, or the exact concentrations of CAN-1 and CAN-2.

Boris Jordan, Curaleaf's chairman and CEO, framed the moment carefully. "Spain, a country of nearly 50 million people, has always been central to Curaleaf's vision for Europe, and this registration is a defining moment for us. We were the first company to be licensed here in 2020, and we believe we are the first to register under this new framework today," he said.

Patients get oral oil, nothing else

The only authorized formula so far is an oily oral solution, defined in AEMPS monograph FN/2026/FMT/043. It allows THC-dominant inputs of 5 to 150 mg THC/ml and CBD-dominant inputs of 10 to 150 mg CBD/ml, diluted in MCT oil. Adult dosing is capped at 32.4 mg of THC per day and 25 mg of CBD per kilogram per day. The finished formula has a 30-day shelf life.

Four last-line indications qualify: spasticity from multiple sclerosis, severe refractory epilepsy, chemotherapy-induced nausea and vomiting, and refractory chronic pain.^[1]

For our readers, the key point is what the monograph excludes. It does not authorize dried flower, smoking, vaporized flower, liquid vape cartridges, or topicals. A Spanish patient cannot get a cannabis vape through this program. Curaleaf does own certified inhalation hardware: in May 2025 it secured EU Class IIa medical-device certification for a rechargeable liquid-inhalation vape built with Jupiter Research. But device certification does not authorize a cannabis formulation, and no Spanish inhalation monograph existed as of this week. The decree lets AEMPS add monographs as evidence evolves, so an inhalation route remains possible but not current.

Doctors and pharmacists urge caution

The Spanish Society of Hospital Pharmacy, which says it represents about 4,500 specialists, called in March for careful rollout. "Given the current absence of solid clinical evidence for certain indications, it is imperative that the integration of medicinal cannabis into clinical practice be carried out under a scientific and evaluable approach," the society said, calling for "a unified monitoring system for effectiveness and safety."

The evidence base is uneven. A 2023 umbrella review of 101 meta-analyses found that "cannabidiol is effective in people with epilepsy. Cannabis based medicines are effective in people with multiple sclerosis, chronic pain, inflammatory bowel disease, and in palliative medicine but not without adverse events."^[3] Eduard Vieta, head of psychiatry at Hospital Clínic Barcelona and a coauthor of that review, said the medicinal program "not be the back door to facilitate the use of cannabis in the general population."

Chronic pain, potentially the largest eligible group, has the most contested data. David Finn, professor of pharmacology at the University of Galway, said preclinical evidence for cannabinoid pain relief is strong "but the clinical evidence is weaker, in large part due to low quality studies with low sample size or short duration of treatment."

Others worry the hospital-only design will choke access. Guillermo Velasco, a cannabinoid researcher at Universidad Complutense de Madrid, told High Times the model "could end up making access difficult for patients, because this medication has to be dispensed in hospital pharmacies, which might create bottlenecks if there is high demand and few specialists to handle it."^[4] Spain's General Council of Official Colleges of Pharmacists has taken that fight to court. The Supreme Court proceeding, recorded as 1/386/2025, challenges the exclusion of community pharmacies. The decree stays in force while the case proceeds.

Five years of North American money built this position

Spain's hospital-first, pharmaceutical-grade model rewards exactly the infrastructure Curaleaf spent five years buying. In April 2021, the company acquired EMMAC Life Sciences for about $50 million in cash plus 17.5 million Curaleaf shares, gaining Alicante-based Medalchemy and assets across five European countries. An institutional investor put $130 million into Curaleaf International for a 31.5% stake at the same time. Curaleaf bought that partner out in July 2025, taking full ownership. We traced this pattern of North American capital buying European licenses in our earlier coverage.

The build-out shows in the numbers. International revenue nearly tripled in two years and reached roughly 13.6% of Curaleaf's $1.268 billion consolidated 2025 revenue.^[2] The company does not break out Spanish sales, and Spain has none to report yet.

The tests that matter now are concrete: AEMPS listing CAN-1 and CAN-2 in its public register, a first hospital supply contract, and a first documented dispensation to a patient. Curaleaf offered no date for any of them. It said availability through hospital pharmacies was expected "in due course," and its own release carried a securities-law warning that implementation could be delayed or might not occur as anticipated.