First Cannabis‑Based Medications Approved in Spain
Curaleaf announced that it has become the first company to obtain registration for standardized medical cannabis preparations in Spain. The two products — one THC‑dominant and the other CBD‑dominant — were entered into the Spanish Agency for Medicines and Medical Devices (AEMPS) registry under the reference numbers CAN‑1 and CAN‑2.
Details of the registered preparations
The THC‑dominant formulation (CAN‑1) contains a standardized ratio of delta‑9‑tetrahydrocannabinol designed for conditions where psychoactive modulation is clinically indicated. The CBD‑dominant preparation (CAN‑2) delivers a consistent cannabidiol profile intended for therapeutic uses such as epilepsy, anxiety, and inflammatory disorders. Both products meet the purity, potency, and stability criteria set out in the new royal decree.
Regulatory framework behind the approval
On October 7, 2025, the Spanish Council of Ministers adopted Royal Decree 903/2025, which establishes the national regulatory pathway for the production, registration, and use of standardized cannabis‑based medicines. Under this decree, registered preparations are not dispensed directly to patients; instead, they are supplied to hospital pharmacies where they can be incorporated into magistral formulas prescribed by qualified healthcare professionals.
Curaleaf notes that the full operational rollout of the framework is still pending, meaning patient access will follow once the distribution and dispensing infrastructure is fully functional.
Strategic Importance of Spain for Curaleaf
Spain represents a pivotal market for Curaleaf’s European ambitions, bolstered by the company’s existing infrastructure and regulatory track record in the country.
Local operations and licensing milestones
Curaleaf maintains an EU‑GMP‑certified manufacturing facility and a dedicated research laboratory in Alicante. Its Spanish subsidiary, Medalchemy SL, previously secured the first AEMPS license authorizing the processing of medical cannabis derivatives for commercial distribution, a milestone achieved in 2020.
Leadership perspective
Boris Jordan, President and Chief Executive Officer of Curaleaf, highlighted the significance of the recent registration:
“Spain, a country with a population of nearly 50 million, has always played a central role in Curaleaf’s vision for Europe, and this registration marks a decisive turning point for us.”
Jordan added that the achievement reflects the team’s expertise, sustained investment in scientific research, and a commitment to providing patients with standardized, high‑quality cannabis‑based medicines.
By aligning its operations with Spain’s newly established regulatory regime, Curaleaf positions itself to contribute to the evolving landscape of medical cannabis therapy across Europe.
