Marijuana multistate operator Curaleaf Holdings has registered two standardized cannabis preparations in Spain, which the company says clears a regulatory path to supply the country’s hospital pharmacies with THC and CBD products under a new national medical cannabis framework.
The Spanish Agency of Medicines and Medical Devices, known as AEMPS, approved two preparations developed by Curaleaf’s Spanish manufacturing facility, Curaleaf said in a Monday press release.
“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,” Curaleaf Chairman and CEO Boris Jordan said in a statement.
One Curaleaf cannabis preparation is THC-dominant, registered as CAN-1; and the other is CBD-dominant, registered as CAN-2.
The registry numbering confirms Curaleaf is the first to register under the framework, the company said.
Can cannabis be dispensed in European hospitals?
The preparations can be used in hospital pharmacies to produce compounded formulas prescribed by healthcare professionals. The products are expected to reach patients through those pharmacies.
The approvals fall under Royal Decree 903/2025, which Spain’s Council of Ministers passed on Oct. 7.
The decree sets Spain’s first formal national pathway for the medicinal use of standardized cannabis preparations, spelling out requirements for production, quality standards and registration with AEMPS. It gives patients a clear route to access cannabis through the public health system.
How long has Curaleaf operated in Spain?
The registrations build on Curaleaf’s long-established presence in Spain. The company operates an EU-GMP-certified manufacturing facility and research and development laboratory in Alicante, according to the press release.
In May 2020, its EU-GMP lab, Medalchemy SL, secured the first license AEMPS granted to process medicinal cannabis derivatives for commercial distribution, an early step that set the stage for the approval of the cannabis preparations.
Subscribe to the MJBiz Factbook
Exclusive industry data and analysis to help you make informed business decisions and avoid costly missteps. All the facts, none of the hype.
What you will get:
- Monthly and quarterly updates, with new data & insights
- Financial forecasts + capital investment trends
- State-by-state guide to regulations, taxes & market opportunities
- Annual survey of cannabis businesses
- Consumer insights
- And more!
“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,” Jordan said.
“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.”
Curaleaf said it will keep working with healthcare professionals and partners to support patient access as Spain’s regulated system takes shape.
