Key Takeaways:
Curaleaf Holdings Inc. received formal approval from the Spanish Agency of Medicines and Medical Devices to register two standardized cannabis preparations, making it the first company to clear the regulatory pathway under the country's new medicinal cannabis framework.
"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," Boris Jordan, chief executive officer and chairman of Curaleaf, said. "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."
The AEMPS approved a THC-dominant and a CBD-dominant preparation developed by Curaleaf's Spanish manufacturing subsidiary, assigning them registry numbers CAN-1 and CAN-2. The registrations clear the way for the preparations to be supplied to hospital pharmacies, where they can be used in magistral formulas under medical prescription, according to a company statement Monday.
The approvals come under Royal Decree 903/2025, which Spain's Council of Ministers approved on Oct. 7, 2025, establishing for the first time a national regulatory framework for medicinal cannabis. The decree sets requirements for production, quality standards and registration with AEMPS, creating a formal pathway for patients to access standardized cannabis preparations through the public healthcare system.
Curaleaf's registrations build on a long-established presence in Spain. The company operates an EU-GMP certified manufacturing facility and research-and-development laboratory in Alicante. In May 2020, its EU-GMP laboratory Medalchemy SL secured the first license ever granted by AEMPS to process medicinal cannabis derivatives for commercial distribution.
The milestone positions Curaleaf as a first-mover in Spain's emerging pharmaceutical cannabis market, a country of about 50 million people. The standardized preparations are expected to become available through hospital pharmacies in due course as the regulated system takes shape, the company said. Curaleaf will continue working with health-care professionals and partners to support patient access.
The registration signals management expects Spain's regulated cannabis market to open a new revenue stream for international operations. Investors will watch the pace of hospital pharmacy adoption and any subsequent regulatory expansions across Europe as key catalysts.
This article is for informational purposes only and does not constitute investment advice.
