Curaleaf Holdings, Inc., a leading international provider of consumer cannabis products, today announced that 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'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 pursuant to 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's registrations under this new framework mark one of the first steps in bringing that pathway to life.
The registrations build on Curaleaf's long-established presence in Spain, where the Company operates an EU-GMP certified manufacturing facility and R&D laboratory in Alicante. 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, an early milestone that laid the foundation for today's achievement.
'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," said Boris Jordan, CEO and Chairman of Curaleaf. "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. This achievement reflects the strength of our team, our sustained investment in science, and our conviction that patients deserve access to standardized, high-quality cannabis medicines."
The standardized preparations are expected to become available to patients through hospital pharmacies in due course, in line with the requirements of the new framework. Curaleaf will continue to work alongside healthcare professionals and partners to support access as Spain's regulated system takes shape.
