Curaleaf Becomes First Company Registered Under Spain’s New Medical Cannabis Framework

Curaleaf Holdings (TSX: CURA) (OTCQX: CURLF) has become the first company to secure registration for standardized medical cannabis preparations under Spain’s newly established regulatory framework, marking a significant milestone in the country’s long-awaited rollout of regulated medical cannabis.

The Spanish Agency of Medicines and Medical Devices (AEMPS) approved two pharmaceutical-grade cannabis preparations developed by Curaleaf’s Spanish manufacturing subsidiary—one THC-dominant and one CBD-dominant. Registered as CAN-1 and CAN-2, the products are expected to supply hospital pharmacies, where they can be used to prepare magistral formulas prescribed by physicians.

The registrations are among the first tangible outcomes of Royal Decree 903/2025, which established Spain’s national framework for standardized medical cannabis preparations after receiving approval from the Council of Ministers last October.

A First-Mover Advantage In One Of Europe’s Largest Markets

For Curaleaf, the announcement represents more than another regulatory approval.

Spain, with nearly 50 million residents, is widely viewed as one of Europe’s most important long-term medical cannabis markets. Until now, however, the country lacked a national pathway allowing standardized cannabis preparations to move through the healthcare system.

Royal Decree 903/2025 changes that by establishing manufacturing standards, quality requirements, and a formal registration process overseen by AEMPS.

Curaleaf says its products are the first to complete that process.

“Spain has always been central to Curaleaf’s vision for Europe,” Chairman and CEO Boris Jordan said in a statement.

“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 added that the registration reflects the company’s long-term investment in pharmaceutical manufacturing and research.

“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.”

Building On An Existing European Footprint

The latest approval builds on Curaleaf’s existing infrastructure in Spain.

The company operates an EU-GMP-certified manufacturing facility and research laboratory in Alicante, where its subsidiary Medalchemy has been active for several years.

In 2020, Medalchemy became the first company to receive an AEMPS license authorizing the processing of medicinal cannabis derivatives for commercial distribution in Spain—a milestone that positioned Curaleaf well ahead of many international competitors as the country’s regulatory framework evolved.

The new registrations extend that first-mover advantage into commercial supply.

Once implementation of the decree progresses, hospital pharmacies will be able to use Curaleaf’s standardized preparations in magistral formulations prescribed by physicians under Spain’s healthcare system.

Europe Continues To Drive Curaleaf’s International Strategy

The announcement also reinforces Europe’s growing importance within Curaleaf’s broader business strategy.

During the recent IgniteIt Cannabis Capital Conference in Chicago, Jordan described the company’s European operations as one of its most valuable strategic assets, noting that the region’s regulated medical markets continue to expand while offering significantly larger long-term growth opportunities than many investors currently recognize.

Spain represents another step in that expansion.

Rather than waiting for broader recreational legalization, Curaleaf has continued investing in pharmaceutical-grade manufacturing, regulatory compliance, and medical distribution infrastructure designed to serve emerging European medical cannabis markets.

The company said it will continue working with healthcare providers and regulatory partners as Spain’s new medical cannabis framework moves toward full implementation and patient access expands through hospital pharmacies.

As more European countries establish standardized medical cannabis systems, first movers with established manufacturing capacity and regulatory approvals may be well positioned to capture market share as physician prescribing increases.