Curaleaf First to Register Cannabis Preparations in Spain

Spain’s medical cannabis system has its first registered products, and Curaleaf International got there before anyone else. Spain’s medicines regulator has approved two standardized cannabis oils — one THC-dominant, one CBD-dominant — clearing them for supply to hospital pharmacies under Spain’s new national medical cannabis framework.

The two preparations carry the registry numbers CAN-1 and CAN-2, the sequence that confirms Curaleaf as the first company through the door. Both were developed at the company’s EU-GMP-certified manufacturing site in Alicante and registered with the Spanish Agency of Medicines and Medical Devices, known as AEMPS.

What the registration actually clears

Getting registered is not the same as reaching patients, and Spain’s framework draws that line sharply. Under Royal Decree 903/2025, which Spain’s Council of Ministers approved on October 7, 2025, standardized cannabis preparations can only be turned into finished medicines inside authorized hospital pharmacies, which compound them into individually prescribed magistral formulas. Prescriptions are reserved for hospital-based specialists treating specific conditions; general practitioners and private clinics are shut out. Raw flower is excluded entirely, and the system runs on standardized extracts with a defined THC and CBD content.

The registry Curaleaf just entered is the gate to the whole system. AEMPS maintains a public register of standardized preparations, and a product has to be listed there before any hospital pharmacy is allowed to use it. Preparations that contain 0.2% THC or more are treated as controlled psychotropic substances, which brings tighter oversight on manufacturing, distribution and traceability. Manufacturers also have to be established in the European Union and to meet EU good-manufacturing-practice standards, with documented supply-chain auditing.

The decree does not fix a closed list of conditions. It points instead to monographs that AEMPS publishes in the National Formulary, which set the indications, dosing and preparation standards for each formula. The government leaned on evidence that is strongest for four uses: spasticity in multiple sclerosis, severe treatment-resistant epilepsy, nausea and vomiting caused by chemotherapy, and chronic pain that has not responded to other treatment.

A market built for oils, not flower

The commercial shape of the Spanish market is unusual, and it favors exactly the kind of product Curaleaf registered. Patients do not pay for the cannabis preparations dispensed through hospital pharmacies. That pushes revenue through institutional hospital procurement rather than the retail or direct-to-patient channels that define the UK’s growing import market and Germany’s, a structure that rewards pharmaceutical-grade extract makers over flower importers.

That distinction is becoming the European pattern. Spain and France both launched hospital-oriented programs that leave flower out, and Germany, the continent’s largest market, has moved to strip cannabis flower from statutory health insurance and impose an extract-only trial period. The advantage is tilting toward standardized oils, capsules and device-delivered formats that clinicians can dose and monitor like conventional medicines. Germany and Austria have already cleared standardized cannabis extracts as approved pain medicines, a sign of where prescribing is heading.

Curaleaf has spent years positioning for that outcome. Its Spanish subsidiary secured the first AEMPS license to process medicinal cannabis derivatives in May 2020, and the company has built its European supply chain around extract manufacturing rather than dried flower. Boris Jordan, the company’s chairman and chief executive, called the Spanish registration “a defining moment,” noting that Curaleaf was both the first company licensed in the country in 2020 and, it believes, the first to register under the new rules.

What patients and operators should watch

The registration clears a regulatory path; it does not yet put oil in patients’ hands. Hospital pharmacies still have to procure the preparations, and the products are expected to reach patients through those pharmacies over the coming months rather than immediately. How quickly that happens depends on hospital capacity, the monographs AEMPS finalizes, and how many specialists are ready to prescribe.

The framework’s central restriction is also contested. Trade coverage has reported that Spain’s community pharmacists have challenged the hospital-only limit before the country’s Supreme Court, arguing that neighborhood pharmacies are legally capable of compounding these formulas and that confining preparation to hospitals restricts access, especially for patients in rural areas. A ruling in their favor could reshape where Spanish patients eventually collect their medicine.

For now the domestic supply base is thin. Spain has allowed cannabis cultivation and processing for years, but only for export, and as of mid-2026 just four companies held AEMPS cultivation licenses. Curaleaf’s head start, first to process and first to register, gives it the strongest position in a market that is finally opening to its own patients, on terms that happen to suit the way the company already builds its medicines.