STAMFORD, Conn. — The Spanish Agency of Medicines and Medical Devices (“AEMPS”) has formally approved the registration of two standardized cannabis preparations (THC-dominant and CBD-dominant) developed by Curaleaf Holdings Inc.’s Spanish manufacturing subsidiary. These registrations clear the regulatory pathway for the supply of preparations to hospital pharmacies, where they can be used in the production of magistral formulas for medical prescription. Based on the official registry numbering (CAN-1 and CAN-2), Curaleaf is the first company to register standardized cannabis preparations in Spain under the country’s new regulatory framework, Royal Decree 903/2025.
Approved by Spain’s Council of Ministers on October 7, 2025, Royal Decree 903/2025 establishes Spain’s regulatory framework for the medicinal use of standardized cannabis preparations, setting out the requirements for their production, quality standards, and registration with AEMPS. It provides, for the first time, a clear national pathway for patients to access standardized cannabis preparations through the healthcare system.
Curaleaf operates an EU-GMP certified manufacturing facility and R&D laboratory in Alicante, Spain. In May 2020, Curaleaf’s EU-GMP laboratory, Medalchemy SL, secured the first-ever license granted by AEMPS to process medicinal cannabis derivatives for commercial distribution.
